AU2024204066A1

AU2024204066A1 - Feedback for sleep conditions

Info

Publication number: AU2024204066A1
Application number: AU2024204066A
Authority: AU
Inventors: Sam COFFEY; Niall Andrew FOX; Christopher Andrew Wakeley GILL; Graeme Alexander Lyon; Richard Charles Napper; Roxana TIRON; Alison Jane WIMMS
Original assignee: Resmed Pty Ltd; Resmed Asia Pacific Ltd; Resmed Sensor Technologies Ltd
Current assignee: Resmed Pty Ltd; Resmed Asia Pacific Ltd; Resmed Sensor Technologies Ltd
Priority date: 2023-06-20
Filing date: 2024-06-14
Publication date: 2025-01-16

Abstract

A feedback system for assisting one or more sleep condition of a patient with is disclosed. The feedback system comprises: one or more sensors configured to generate sensor data associated with the patient; a memory storing machine-readable instructions; and a computing system including one or more processors. The one or more processors are configured to execute the machine-readable instructions to implement a patient feedback process, by: receiving sensor data from the one or more sensors relating to at least two of the following conditions of the patient: i) sleep hygiene; ii) sleep performance; iii) risk of having an undiagnosed sleeping disorder, and iv) respiratory therapy; processing the sensor data to determine a correlation between the at least two of: i), ii), iii) and iv); and generating a feedback response to the patient responsive to the determined correlation. A2578192 12.0 73 20913400_1 (GHMatters) P120887.AU.1

Description

FEEDBACK FOR SLEEP CONDITIONS

1 BACKGROUND OF THE TECHNOLOGY 1.1 FIELD OF THE TECHNOLOGY

[0001] The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and amelioration of sleep conditions including sleep disorders including sleep disordered breathing and/or respiratory-related disorders. The present technology also relates to medical devices or apparatus, and their use.

1.2 DESCRIPTION OF THE RELATED ART

1.2.1 Human Respiratory System and its Disorders

[0002] The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the airways of a patient.

[0003] The airways include a series of branching tubes, which become narrower, shorter and more numerous as they penetrate deeper into the lung. The prime function of the lung is gas exchange, allowing oxygen to move from the inhaled air into the venous blood and carbon dioxide to move in the opposite direction. The trachea divides into right and left main bronchi, which further divide eventually into terminal bronchioles. The bronchi make up the conducting airways, and do not take part in gas exchange. Further divisions of the airways lead to the respiratory bronchioles, and eventually to the alveoli. The alveolated region of the lung is where the gas exchange takes place, and is referred to as the respiratory zone. See "RespiratoryPhysiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0004] A range of respiratory disorders exist. Certain disorders may be characterised by particular events, e.g. apneas, hypopneas, and hyperpneas.

[0005] Examples of respiratory disorders include Obstructive Sleep Apnea (OSA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD) and Chest wall disorders.

[0006] Obstructive Sleep Apnea (OSA), a form of Sleep Disordered Breathing (SDB), is characterised by events including occlusion or obstruction of the upper air passage during sleep. It results from a combination of an abnormally small upper

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20913400_1 (GHMatters) P120887.AU.1 airway and the normal loss of muscle tone in the region of the tongue, soft palate and posterior oropharyngeal wall during sleep. The condition causes the affected patient to stop breathing for periods typically of 30 to 120 seconds in duration, sometimes 200 to 300 times per night. It often causes excessive daytime somnolence, and it may cause cardiovascular disease and brain damage. The syndrome is a common disorder, particularly in middle aged overweight males, although a person affected may have no awareness of the problem, e.g. see US Patent No. 4,944,310 (Sullivan).

[0007] Cheyne-Stokes Respiration (CSR) is another form of sleep disordered breathing. CSR is a disorder of a patient's respiratory controller in which there are rhythmic alternating periods of waxing and waning ventilation known as CSR cycles. CSR is characterised by repetitive de-oxygenation and re-oxygenation of the arterial blood. It is possible that CSR is harmful because of the repetitive hypoxia. In some patients CSR is associated with repetitive arousal from sleep, which causes severe sleep disruption, increased sympathetic activity, and increased afterload, e.g. see US Patent No. 6,532,959 (Berthon-Jones).

[0008] Respiratory failure is an umbrella term for respiratory disorders in which the lungs are unable to inspire sufficient oxygen or exhale sufficient C02 to meet the patient's needs. Respiratory failure may encompass some or all of the following disorders.

[0009] A patient with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath on exercise.

[0010] Obesity Hypoventilation Syndrome (OHS) is defined as the combination of severe obesity and awake chronic hypercapnia, in the absence of other known causes for hypoventilation. Symptoms include dyspnea, morning headache and excessive daytime sleepiness.

[0011] Chronic Obstructive Pulmonary Disease (COPD) encompasses any of a group of lower airway diseases that have certain characteristics in common. These include increased resistance to air movement, extended expiratory phase of respiration, and loss of the normal elasticity of the lung. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (primary risk factor), occupational exposures, air pollution and genetic factors. Symptoms include: dyspnea on exertion, chronic cough and sputum production.

[0012] Neuromuscular Disease (NMD) is a broad term that encompasses many diseases and ailments that impair the functioning of the muscles either directly via A2578192 12.0 2

20913400_1 (GHMatters) P120887.AU.1 intrinsic muscle pathology, or indirectly via nerve pathology. Some NMD patients are characterised by progressive muscular impairment leading to loss of ambulation, being wheelchair-bound, swallowing difficulties, respiratory muscle weakness and, eventually, death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) Rapidly progressive disorders: Characterised by muscle impairment that worsens over months and results in death within a few years (e.g. Amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) Variable or slowly progressive disorders: Characterised by muscle impairment that worsens over years and only mildly reduces life expectancy (e.g. Limb girdle, Facioscapulohumeral and Myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing generalised weakness, dysphagia, dyspnea on exertion and at rest, fatigue, sleepiness, morning headache, and difficulties with concentration and mood changes.

[0013] Chest wall disorders are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the thoracic cage. The disorders are usually characterised by a restrictive defect and share the potential of long term hypercapnic respiratory failure. Scoliosis and/or kyphoscoliosis may cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral oedema, orthopnea, repeated chest infections, morning headaches, fatigue, poor sleep quality and loss of appetite.

[0014] A range of therapies have been used to treat or ameliorate such conditions. Furthermore, otherwise healthy individuals may take advantage of such therapies to prevent respiratory disorders from arising. However, these have a number of shortcomings. 1.2.2 Therapies

[0015] Various respiratory therapies, such as Continuous Positive Airway Pressure (CPAP) therapy, Non-invasive ventilation (NIV), Invasive ventilation (IV), and High Flow Therapy (HFT) have been used to treat one or more of the above respiratory disorders. 1.2.2.1 Respiratory pressure therapies

[0016] Respiratory pressure therapy is the application of a supply of air to an entrance to the airways at a controlled target pressure that is nominally positive with

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20913400_1 (GHMatters) P120887.AU.1 respect to atmosphere throughout the patient's breathing cycle (in contrast to negative pressure therapies such as the tank ventilator or cuirass).

[0017] Continuous Positive Airway Pressure (CPAP) therapy has been used to treat Obstructive Sleep Apnea (OSA). The mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and may prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by CPAP therapy may be voluntary, and hence patients may elect not to comply with therapy if they find devices used to provide such therapy one or more of: uncomfortable, difficult to use, expensive and aesthetically unappealing.

[0018] Non-invasive ventilation (NIV) provides ventilatory support to a patient through the upper airways to assist the patient breathing and/or maintain adequate oxygen levels in the body by doing some or all of the work of breathing. The ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure, in forms such as OHS, COPD, NMD and Chest Wall disorders. In some forms, the comfort and effectiveness of these therapies may be improved.

[0019] Invasive ventilation (IV) provides ventilatory support to patients that are no longer able to effectively breathe themselves and may be provided using a tracheostomy tube or endotracheal tube. In some forms, the comfort and effectiveness of these therapies may be improved. 1.2.2.2 Flow therapies

[0020] Not all respiratory therapies aim to deliver a prescribed therapeutic pressure. Some respiratory therapies aim to deliver a prescribed respiratory volume, by delivering an inspiratory flow rate profile over a targeted duration, possibly superimposed on a positive baseline pressure. In other cases, the interface to the patient's airways is 'open' (unsealed) and the respiratory therapy may only supplement the patient's own spontaneous breathing with a flow of conditioned or enriched gas. In one example, High Flow therapy (HFT) is the provision of a continuous, heated, humidified flow of air to an entrance to the airway through an unsealed or open patient interface at a "treatment flow rate" that may be held approximately constant throughout the respiratory cycle. The treatment flow rate is nominally set to exceed the patient's peak inspiratory flow rate. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One A2578192 12.0 4

20913400_1 (GHMatters) P120887.AU.1 mechanism of action is that the high flow rate of air at the airway entrance improves ventilation efficiency by flushing, or washing out, expired C02 from the patient's anatomical deadspace. Hence, HFT is thus sometimes referred to as a deadspace therapy (DST). Other benefits may include the elevated warmth and humidification (possibly of benefit in secretion management) and the potential for modest elevation of airway pressures. As an alternative to constant flow rate, the treatment flow rate may follow a profile that varies over the respiratory cycle.

[0021] Another form of flow therapy is long-term oxygen therapy (LTOT) or supplemental oxygen therapy. Doctors may prescribe a continuous flow of oxygen enriched air at a specified oxygen concentration (from 21%, the oxygen fraction in ambient air, to 100%) at a specified flow rate (e.g., 1 litre per minute (LPM), 2 LPM, 3 LPM, etc.) to be delivered to the patient's airway. 1.2.2.3 Supplementary oxygen

[0022] For certain patients, oxygen therapy may be combined with a respiratory pressure therapy or HFT by adding supplementary oxygen to the pressurised flow of air. When oxygen is added to respiratory pressure therapy, this is referred to as RPT with supplementary oxygen. When oxygen is added to HFT, the resulting therapy is referred to as HFT with supplementary oxygen. 1.2.3 Respiratory Therapy Systems

[0023] These respiratory therapies may be provided by a respiratory therapy system or device. Such systems and devices may also be used to screen, diagnose, or monitor a condition without treating it.

[0024] A respiratory therapy system may comprise a Respiratory Pressure Therapy Device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0025] Another form of therapy system is a mandibular repositioning device. 1.2.3.1 Patient Interface

[0026] A patient interface may be used to interface respiratory equipment to its wearer, for example by providing a flow of air to an entrance to the airways. The flow of air may be provided via a mask to the nose and/or mouth, a tube to the mouth or a tracheostomy tube to the trachea of a patient. Depending upon the therapy to be applied, the patient interface may form a seal, e.g., with a region of the patient's face, to facilitate the delivery of gas at a pressure at sufficient variance with ambient

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20913400_1 (GHMatters) P120887.AU.1 pressure to effect therapy, e.g., at a positive pressure of about 10 cmH20 relative to ambient pressure. For other forms of therapy, such as the delivery of oxygen, the patient interface may not include a seal sufficient to facilitate delivery to the airways of a supply of gas at a positive pressure of about 10 cmH20. For flow therapies such as nasal HFT, the patient interface is configured to insufflate the nares but specifically to avoid a complete seal. One example of such a patient interface is a nasal cannula. 1.2.3.2 Seal-forming structure

[0027] Patient interfaces may include a seal-forming structure. Since it is in direct contact with the patient's face, the shape and configuration of the seal-forming structure can have a direct impact the effectiveness and comfort of the patient interface.

[0028] A patient interface may be partly characterised according to the design intent of where the seal-forming structure is to engage with the face in use. In one form of patient interface, a seal-forming structure may comprise a first sub-portion to form a seal around the left naris and a second sub-portion to form a seal around the right naris. In one form of patient interface, a seal-forming structure may comprise a single element that surrounds both nares in use. Such single element may be designed to for example overlay an upper lip region and a nasal bridge region of a face. In one form of patient interface a seal-forming structure may comprise an element that surrounds a mouth region in use, e.g. by forming a seal on a lower lip region of a face. In one form of patient interface, a seal-forming structure may comprise a single element that surrounds both nares and a mouth region in use. These different types of patient interfaces may be known by a variety of names by their manufacturer including nasal masks, full-face masks, nasal pillows, nasal puffs and oro-nasal masks.

[0029] A seal-forming structure that may be effective in one region of a patient's face may be inappropriate in another region, e.g. because of the different shape, structure, variability and sensitivity regions of the patient's face. For example, a seal on swimming goggles that overlays a patient's forehead may not be appropriate to use on a patient's nose.

[0030] Certain seal-forming structures may be designed for mass manufacture such that one design is able to fit and be comfortable and effective for a wide range of different face shapes and sizes. To the extent to which there is a mismatch between

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20913400_1 (GHMatters) P120887.AU.1 the shape of the patient's face, and the seal-forming structure of the mass manufactured patient interface, one or both must adapt in order for a seal to form.

[0031] One type of seal-forming structure extends around the periphery of the patient interface, and is intended to seal against the patient's face when force is applied to the patient interface with the seal-forming structure in confronting engagement with the patient's face. The seal-forming structure may include an air or fluid filled cushion, or a moulded or formed surface of a resilient seal element made of an elastomer such as a rubber. With this type of seal-forming structure, if the fit is not adequate, there will be gaps between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face in order to achieve a seal.

[0032] Another type of seal-forming structure incorporates a flap seal of thin material positioned about the periphery of the mask so as to provide a self-sealing action against the face of the patient when positive pressure is applied within the mask. Like the previous style of seal-forming portion, if the match between the face and the mask is not good, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match that of the patient, it may crease or buckle in use, giving rise to leaks.

[0033] Another type of seal-forming structure may comprise a friction-fit element, e.g. for insertion into a naris, however some patients find these uncomfortable.

[0034] A range of patient interface seal-forming structure technologies are disclosed in the following patent applications: WO 1998/004310; WO 2006/074513; WO 2010/135785.

[0035] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow, or nasal puff is the subject of US Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0036] ResMed Inc. has manufactured the following products that incorporate nasal pillows: SWIFTTM nasal pillows mask, SWIFTTM II nasal pillows mask, SWIFTTM LT nasal pillows mask, SWIFTTM FX nasal pillows mask and MIRAGE LIBERTYTM full-face mask. The following patent applications describe examples of nasal pillows masks: International Patent Application WO 2004/073778 (describing amongst other things aspects of the SWIFTTM nasal pillows mask), US Patent Application 2009/0044808 (describing amongst other things aspects of the SWIFTTM A2578192 12.0 7

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LT nasal pillows mask); International Patent Applications WO 2005/063328 and WO 2006/130903 (describing amongst other things aspects of the MIRAGE LIBERTYTM full-face mask); International Patent Application WO 2009/052560 (describing amongst other things aspects of the SWIFTTM FX nasal pillows mask). 1.2.3.3 Positioning and Stabilising Structure

[0037] A seal-forming structure of a patient interface used for positive air pressure therapy is subject to the corresponding force of the air pressure to disrupt a seal. Thus a variety of techniques have been used to position the seal-forming structure, and to maintain it in sealing relation with the appropriate portion of the face. Several factors may be considered when comparing different positioning and stabilising techniques. These include: how effective the technique is at maintaining the seal-forming structure in the desired position and in sealed engagement with the face during use of the patient interface; how comfortable the interface is for the patient; whether the patient feels intrusiveness and/or claustrophobia when wearing the patient interface; and aesthetic appeal.

[0038] One technique is the use of adhesives, e.g. see US Patent Application Publication No. US 2010/0000534.

[0039] Another technique is the use of one or more straps and/or stabilising harnesses. Many such harnesses suffer from being one or more of ill-fitting, bulky, uncomfortable and awkward to use. 1.2.3.4 Pressurised Air Conduit

[0040] In one type of treatment system, a flow of pressurised air is provided to a patient interface through a conduit in an air circuit that fluidly connects to the patient interface at a location that is in front of the patient's face when the patient interface is positioned on the patient's face during use. The conduit may extend from the patient interface forwards away from the patient's face. 1.2.3.4.1 Pressurised Air Conduit used for Positioning / Stabilising the Seal Forming Structure

[0041] Another type of treatment system comprises a patient interface in which a tube that delivers pressurised air to the patient's airways also functions as part of the headgear to position and stabilise the seal-forming portion of the patient interface at the appropriate part of the patient's face. This type of patient interface may be referred to as having "conduit headgear" or "headgear tubing". Such patient interfaces allow the conduit in the air circuit providing the flow of pressurised air from a A2578192 12.0 8

20913400_1 (GHMatters) P120887.AU.1 respiratory pressure therapy (RPT) device to connect to the patient interface in a position other than in front of the patient's face. One example of such a treatment system is disclosed in US Patent Publication No. US 2007/0246043, the contents of which are incorporated herein by reference, in which the conduit connects to a tube in the patient interface through a port positioned in use on top of the patient's head.

[0042] It is desirable for patient interfaces incorporating headgear tubing to be comfortable for a patient to wear over a prolonged duration when the patient is asleep, form an air-tight and stable seal with the patient's face, while also able to fit a range of patient head shapes and sizes. 1.2.3.5 Respiratory Pressure Therapy (RPT) Device

[0043] A respiratory pressure therapy (RPT) device may be used individually or as part of a system to deliver one or more of a number of therapies described above, such as by operating the device to generate a flow of air for delivery to an interface to the airways. The flow of air may be pressure-controlled (for respiratory pressure therapies) or flow-controlled (for flow therapies such as HFT). Thus RPT devices may also act as flow therapy devices. Examples of RPT devices include a CPAP device and a ventilator.

[0044] Air pressure generators are known in a range of applications, e.g. industrial-scale ventilation systems. However, air pressure generators for medical applications have particular requirements not fulfilled by more generalised air pressure generators, such as the reliability, size and weight requirements of medical devices. In addition, even devices designed for medical treatment may suffer from shortcomings, pertaining to one or more of: comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost, and reliability.

[0045] An example of the special requirements of certain RPT devices is acoustic noise.

[0046] Table of noise output levels of prior RPT devices (one specimen only, measured using test method specified in ISO 3744 in CPAP mode at 10 cmH20). RPT Device name A-weighted sound Year (approx.) pressure level dB(A) C-Series Tango TM 31.9 2007 C-Series Tango TM with Humidifier 33.1 2007 S8 Escape TM II 30.5 2005

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S8 Escape TM II with H4i TM Humidifier 31.1 2005 S9 AutoSetTM 26.5 2010 S9 AutoSetTM with H5i Humidifier 28.6 2010

[0047] One known RPT device used for treating sleep disordered breathing is the S9 Sleep Therapy System, manufactured by ResMed Inc. Another example of an RPT device is a ventilator. Ventilators such as the ResMed StellarTM Series of Adult and Paediatric Ventilators may provide support for invasive and non-invasive non dependent ventilation for a range of patients for treating a number of conditions such as but not limited to NMD, OHS and COPD.

[0048] The ResMed Elis6e TM 150 ventilator and ResMed VS IIITM ventilator may provide support for invasive and non-invasive dependent ventilation suitable for adult or paediatric patients for treating a number of conditions. These ventilators provide volumetric and barometric ventilation modes with a single or double limb circuit. RPT devices typically comprise a pressure generator, such as a motor-driven blower or a compressed gas reservoir, and are configured to supply a flow of air to the airway of a patient. In some cases, the flow of air may be supplied to the airway of the patient at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface such as those described above.

[0049] The designer of a device may be presented with an infinite number of choices to make. Design criteria often conflict, meaning that certain design choices are far from routine or inevitable. Furthermore, the comfort and efficacy of certain aspects may be highly sensitive to small, subtle changes in one or more parameters. 1.2.3.6 Air circuit

[0050] An air circuit is a conduit or a tube constructed and arranged to allow, in use, a flow of air to travel between two components of a respiratory therapy system such as the RPT device and the patient interface. In some cases, there may be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single limb air circuit is used for both inhalation and exhalation. 1.2.3.7 Humidifier

[0051] Delivery of a flow of air without humidification may cause drying of airways. The use of a humidifier with an RPT device and the patient interface produces humidified gas that minimizes drying of the nasal mucosa and increases

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20913400_1 (GHMatters) P120887.AU.1 patient airway comfort. In addition, in cooler climates, warm air applied generally to the face area in and about the patient interface is more comfortable than cold air.

[0052] A range of artificial humidification devices and systems are known, however they may not fulfil the specialised requirements of a medical humidifier.

[0053] Medical humidifiers are used to increase humidity and/or temperature of the flow of air in relation to ambient air when required, typically where the patient may be asleep or resting (e.g. at a hospital). A medical humidifier for bedside placement may be small. A medical humidifier may be configured to only humidify and/or heat the flow of air delivered to the patient without humidifying and/or heating the patient's surroundings. Room-based systems (e.g. a sauna, an air conditioner, or an evaporative cooler), for example, may also humidify air that is breathed in by the patient, however those systems would also humidify and/or heat the entire room, which may cause discomfort to the occupants. Furthermore, medical humidifiers may have more stringent safety constraints than industrial humidifiers

[0054] While a number of medical humidifiers are known, they can suffer from one or more shortcomings. Some medical humidifiers may provide inadequate humidification, some are difficult or inconvenient to use by patients. 1.2.3.8 Data Management

[0055] There may be clinical reasons to obtain data to determine whether the patient prescribed with respiratory therapy has been "compliant", e.g. that the patient has used their RPT device according to one or more "compliance rules". One example of a compliance rule for CPAP therapy is that a patient, in order to be deemed compliant, is required to use the RPT device for at least four hours a night for at least 21 of 30 consecutive days. In order to determine a patient's compliance, a provider of the RPT device, such as a health care provider, may manually obtain data describing the patient's therapy using the RPT device, calculate the usage over a predetermined time period, and compare with the compliance rule. Once the health care provider has determined that the patient has used their RPT device according to the compliance rule, the health care provider may notify a third party that the patient is compliant.

[0056] There may be other aspects of a patient's therapy that would benefit from communication of therapy data to a third party or external system.

[0057] Existing processes to communicate and manage such data can be one or more of costly, time-consuming, and error-prone.

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1.2.3.9 Vent technologies

[0058] Some forms of treatment systems may include a vent to allow the washout of exhaled carbon dioxide. The vent may allow a flow of gas from an interior space of a patient interface, e.g., the plenum chamber, to an exterior of the patient interface, e.g., to ambient.

[0059] The vent may comprise an orifice and gas may flow through the orifice in use of the mask. Many such vents are noisy. Others may become blocked in use and thus provide insufficient washout. Some vents may be disruptive of the sleep of a bed partner 1100 of the patient 1000, e.g. through noise or focussed airflow.

[0060] ResMed Inc. has developed a number of improved mask vent technologies, e.g. see International Patent Application Publication No. WO 1998/034665; International Patent Application Publication No. WO 2000/078381; US Patent No. 6,581,594; US Patent Application Publication No. US 2009/0050156; US Patent Application Publication No. 2009/0044808.

[0061] Table of noise of prior masks (ISO 17510-2:2007, 10 cmH20 pressure at im) Mask name Mask type A-weighted A-weighted Year (approx.) sound power sound pressure level dB(A) dB(A) (uncertainty) (uncertainty) Glue-on(*) nasal 50.9 42.9 1981 ResCare nasal 31.5 23.5 1993 standard(*) ResMed nasal 29.5 21.5 1998 MirageTM(*) ResMed nasal 36(3) 28(3) 2000 UltraMirageT M ResMed nasal 32(3) 24(3) 2002 Mirage ActivaTM

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ResMed nasal 30(3) 22(3) 2008 Mirage MicroTM ResMed nasal 29(3) 22(3) 2008 MirageTM SoftGel ResMed nasal 26(3) 18(3) 2010 MirageTM FX ResMed nasal pillows 37 29 2004 Mirage SwiftTM(*) ResMed nasal pillows 28(3) 20(3) 2005 Mirage SwiftTM II ResMed nasal pillows 25(3) 17(3) 2008 Mirage SwiftTM LT ResMed AirFit nasal pillows 21(3) 13 (3) 2014 P1O

[0062] (*one specimen only, measured using test method specified in ISO 3744 in CPAP mode at 10 cmH20)

[0063] Sound pressure values of a variety of objects are listed below Object A-weighted sound pressure dB(A) Notes Vacuum cleaner: Nilfisk 68 ISO 3744 at Im Walter Broadly Litter Hog: B+ distance Grade Conversational speech 60 1m distance Average home 50 Quiet library 40 Quiet bedroom at night 30 Background in TV studio 20

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1.2.4 Screening, Diagnosis, and Monitoring Systems

[0064] Polysomnography (PSG) is a conventional system for diagnosis and monitoring of cardio-pulmonary disorders, and typically involves expert clinical staff to apply the system. PSG typically involves the placement of 15 to 20 contact sensors on a patient in order to record various bodily signals such as electroencephalography (EEG), electrocardiography (ECG), electrooculograpy (EOG), electromyography (EMG), etc. PSG for sleep disordered breathing has involved two nights of observation of a patient in a clinic, one night of pure diagnosis and a second night of titration of treatment parameters by a clinician. PSG is therefore expensive and inconvenient. In particular, it is unsuitable for home screening / diagnosis/ monitoring of sleep disordered breathing.

[0065] Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening typically gives a true / false result indicating whether or not a patient's SDB is severe enough to warrant further investigation, while diagnosis may result in clinically actionable information. Screening and diagnosis tend to be one-off processes, whereas monitoring the progress of a condition can continue indefinitely. Some screening / diagnosis systems are suitable only for screening / diagnosis, whereas some may also be used for monitoring.

[0066] Clinical experts may be able to screen, diagnose, or monitor patients adequately based on visual observation of PSG signals. However, there are circumstances where a clinical expert may not be available, or a clinical expert may not be affordable. Different clinical experts may disagree on a patient's condition. In addition, a given clinical expert may apply a different standard at different times.

2 BRIEF SUMMARY OF THE TECHNOLOGY

[0067] The present technology is directed towards providing devices used in the screening, diagnosis, monitoring, amelioration, treatment, or prevention of one or more sleep condition including poor sleep hygiene, sleep performance, sleep breathing disorders, or respiratory disorders having one or more of improved comfort, cost, efficacy, ease of use and manufacturability. In the context of the present disclosure, the term "sleep condition" encompasses any sleep characteristic (including

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20913400_1 (GHMatters) P120887.AU.1 sleep hygiene, sleep performance, sleep disorder) as well as therapy that may impact sleep such as respiratory therapy which is often applied whilst a patient is sleeping.

[0068] A first aspect of the present technology relates to apparatus used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of one or more sleep condition.

[0069] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of one or more sleep condition.

[0070] An aspect of certain forms of the present technology is to provide methods and/or apparatus that improve the compliance of patients with respiratory therapy.

[0071] An aspect of certain forms of the present technology is a medical device that is easy to use, e.g. by a person who does not have medical training, by a person who has limited dexterity, vision or by a person with limited experience in using this type of medical device.

[0072] One form of the present technology comprises a feedback system for assisting a patient with i a sleep condition. The patient is provided with assistance by a feedback process set forth below. The feedback system comprises one or more sensors configured to generate sensor data associated with the patient. The feedback system also comprises a memory storing machine-readable instructions. The feedback system also comprises a computing system including one or more processors configured to execute the machine-readable instructions to implement a patient feedback process.

[0073] The patient feedback process is implemented by receiving patient related data relating to at least two of the following conditions of the patient: sleep hygiene; sleep performance; risk of having an undiagnosed sleeping disorder, and respiratory therapy. The patient feedback process is also implemented by processing the patient data to determine a correlation between the at least two of: sleep hygiene; sleep performance; risk of having an undiagnosed sleeping disorder, and respiratory therapy. The patient feedback process is also implemented by generating a feedback response responsive to the determined correlation.

[0074] An aspect of the present technology is that the determined correlation may include a correlation between sleep hygiene and sleep performance. The determined correlation may also include a correlation between sleep hygiene and risk of having an undiagnosed sleeping disorder. The determined correlation may also include a A2578192 12.0 15

20913400_1 (GHMatters) P120887.AU.1 correlation between sleep performance and risk of having an undiagnosed sleeping disorder.

[0075] Another aspect of the present technology is that the determined correlation includes a correlation to, or including, respiratory therapy. For example, the respiratory therapy may include PAP therapy.

[0076] Another aspect of the present technology is that the received patient data includes data associated with a plurality of factors, e.g., heart rate, room temperature, etc., contributing to the patient condition.

[0077] Another aspect of the present technology is that the patient related data may be from sensor data and/or manually inputted data.

[0078] The feedback process further comprises identifying one or more of the factors in the determined correlation. The feedback process further comprises including the identified one or more factors in the generated feedback response.

[0079] Another aspect of the present technology is that the computing system includes a mobile device.

[0080] Another aspect of the present technology is that at least some of the sensor data is derived from a wearable device on the patient.

[0081] Another aspect of the present technology is that the sensor data includes one or more physiological characteristics of the patient.

[0082] Another aspect of the present technology is that at least some of the sensor data is derived from at least one of electroencephalography (EEG), electrocardiography (ECG), electrooculograpy (EOG), and electromyography (EMG) signals of the patient.

[0083] Another aspect of the present technology is that the sensor data is environmental data derived from at least one sensor.

[0084] Another aspect of the present technology is that the environmental data is derived from at least one of a motion sensor, temperature sensor, humidity sensor, light sensor, sonar sensor, tactile sensor, altitude sensor, gas sensor, accelerometer, gyroscope, GPS, or any combination thereof.

[0085] Another aspect of the present technology is that the feedback response is delivered through an output device configured to provide an acoustic, visual, or video output, or combination thereof.

[0086] Another aspect of the present technology is that the feedback response is configured to provide positive reinforcement to the patient. A2578192 12.0 16

20913400_1 (GHMatters) P120887.AU.1

[0087] Another aspect of the present technology is that the feedback response is configured to provide information to assist the patient improving their sleep hygiene and/ or sleep performance and/or respiratory therapy.

[0088] One form of the present technology comprises a system for delivery of pressurised air or breathable gas to a patient. The system comprises a flow generator configured to generate a flow of air. The system also comprises a patient interface constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways. The patient interface can be configured to deliver the pressurised air or breathable gas to the patient's airways for respiratory therapy. The system also comprises an air delivery tube coupled between the flow generator and the patient interface to deliver the flow of air from the flow generator to the patient interface as the pressurised air or breathable gas. The system further comprises one or more first sensors configured to generate sensor data associated with the patient under respiratory therapy.

[0089] The system further comprises a feedback system comprising a memory storing machine-readable instructions. The feedback system also comprises a computing system including one or more processors configured to execute the machine-readable instructions to implement a patient feedback process to assist the patient under respiratory therapy.

[0090] The patient feedback process is implemented by receiving sensor data from the one or more sensors generated under respiratory therapy. The patient feedback process is also implemented by receiving patient related data independent of the respiratory therapy.

[0091] The patient feedback process is also implemented by processing the sensor data and the independent patient data to determine one or more sleep characteristics of the patient. The patient feedback process is also implemented by generating a feedback response responsive to the determined one or more sleep characteristics.

[0092] Another aspect of the present technology is that the one or more sleep characteristic is selected from the group comprising: sleep hygiene; sleep performance; and risk of having an undiagnosed sleeping disorder.

[0093] Another aspect of the present technology is that the computing system includes a mobile device.

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[0094] Another aspect of the present technology is that the patient related independent data includes patient data derived whilst the patient is undergoing respiratory therapy.

[0095] Another aspect of the present technology is that the patient related independent data includes patient data derived whilst the patient is not undergoing respiratory therapy.

[0096] Another aspect of the present technology is that at least some of the patient related independent data is derived from a wearable device on the patient.

[0097] Another aspect of the present technology is that the patient related independent data includes one or more physiological characteristics of the patient.

[0098] Another aspect of the present technology is that at least some of the patient related independent data is derived from at least one of electroencephalography (EEG), electrocardiography (ECG), electrooculograpy (EOG), and electromyography (EMG) signals of the patient.

[0099] Another aspect of the present technology is that the patient related independent data is environmental data derived from at least one sensor.

[0100] Another aspect of the present technology is that the environmental data is derived from at least one of a motion sensor, temperature sensor, humidity sensor, light sensor, sonar sensor, tactile sensor, altitude sensor, gas sensor, accelerometer, gyroscope, GPS, or any combination thereof.

[0101] Another aspect of the present technology is that the feedback response is delivered through an output device configured to provide an acoustic, visual, or video output, or combination thereof.

[0102] Another aspect of the present technology is that the feedback response is an indication of the one or more sleep characteristics.

[0103] Another aspect of the present technology is that the feedback response is an indication of the efficacy of the respiratory therapy.

[0104] Another aspect of the present technology is that the feedback response is configured to provide positive reinforcement to the patient under respiratory therapy.

[0105] Another aspect of the present technology is that the feedback response is configured to provide information to assist in improving efficacy of the respiratory therapy and/or the one or more sleep characteristics identified.

[0106] The methods, systems, devices and apparatus described may be implemented so as to improve the functionality of a processor, such as a processor of A2578192 12.0 18

20913400_1 (GHMatters) P120887.AU.1 a specific purpose computer, respiratory monitor and/or a respiratory therapy apparatus. Moreover, the described methods, systems, devices and apparatus can provide improvements in the technological field of automated management, monitoring and/or treatment of respiratory conditions, including, for example, sleep disordered breathing.

[0107] Of course, portions of the aspects may form sub-aspects of the present technology. Also, various ones of the sub-aspects and/or aspects may be combined in various manners and also constitute additional aspects or sub-aspects of the present technology.

[0108] Other features of the technology will be apparent from consideration of the information contained in the following detailed description, abstract, drawings and claims.

3 BRIEF DESCRIPTION OF THE DRAWINGS

[0109] The present technology is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings, in which like reference numerals refer to similar elements including: 3.1 RESPIRATORY THERAPY SYSTEMS

[0110] Fig. 1A shows a system including a patient 1000 wearing a patient interface 2000, in the form of nasal pillows, receiving a supply of air at positive pressure from an RPT device 3000. Air from the RPT device 3000 is humidified in a humidifier 4000, and passes along an air circuit 3170 to the patient 1000. A bed partner 1100 is also shown. The patient is sleeping in a supine sleeping position.

[0111] Fig. lB shows a system including a patient 1000 wearing a patient interface 2000, in the form of a nasal mask, receiving a supply of air at positive pressure from an RPT device 3000. Air from the RPT device is humidified in a humidifier 4000, and passes along an air circuit 3170 to the patient 1000.

[0112] Fig. IC shows a system including a patient 1000 wearing a patient interface 2000, in the form of a full-face mask, receiving a supply of air at positive pressure from an RPT device 3000. Air from the RPT device is humidified in a humidifier 4000, and passes along an air circuit 3170 to the patient 1000. The patient is sleeping in a side sleeping position.

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3.2 RESPIRATORY SYSTEM AND FACIAL ANATOMY

[0113] Fig. 2A shows an overview of a human respiratory system including the nasal and oral cavities, the larynx, vocal folds, oesophagus, trachea, bronchus, lung, alveolar sacs, heart and diaphragm.

[0114] Fig. 2B shows a view of a human upper airway including the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostril, lip superior, lip inferior, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, oesophagus and trachea.

[0115] Fig. 2C is a front view of a face with several features of surface anatomy identified including the lip superior, upper vermilion, lower vermilion, lip inferior, mouth width, endocanthion, a nasal ala, nasolabial sulcus and cheilion. Also indicated are the directions superior, inferior, radially inward and radially outward.

[0116] Fig. 2D is a side view of a head with several features of surface anatomy identified including glabella, sellion, pronasale, subnasale, lip superior, lip inferior, supramenton, nasal ridge, alar crest point, otobasion superior and otobasion inferior. Also indicated are the directions superior & inferior, and anterior & posterior.

[0117] Fig. 2E is a further side view of a head. The approximate locations of the Frankfort horizontal and nasolabial angle are indicated. The coronal plane is also indicated.

[0118] Fig. 2F shows a base view of a nose with several features identified including naso-labial sulcus, lip inferior, upper Vermilion, naris, subnasale, columella, pronasale, the major axis of a naris and the midsagittal plane. 3.3 PATIENT INTERFACE

[0119] Fig. 3A shows a patient interface in the form of a nasal mask in accordance with one form of the present technology.

[0120] Fig. 3B shows a view of a plenum chamber 2200 showing a sagittal plane and a mid-contact plane.

[0121] Fig. 3C shows a view of a posterior of the plenum chamber of Fig. 3B. The direction of the view is normal to the mid-contact plane. The sagittal plane in Fig. 3D bisects the plenum chamber into left-hand and right-hand sides.

[0122] Fig. 3D shows a cross-section through the plenum chamber of Fig. 3C, the cross-section being taken at the sagittal plane shown in Fig. 3C. A 'mid-contact' plane is shown. The mid-contact plane is perpendicular to the sagittal plane. The orientation of the mid-contact plane corresponds to the orientation of a chord 2210 which lies on A2578192 12.0 20

20913400_1 (GHMatters) P120887.AU.1 the sagittal plane and just touches the cushion of the plenum chamber at two points on the sagittal plane: a superior point 2220 and an inferior point 2230. Depending on the geometry of the cushion in this region, the mid-contact plane may be a tangent at both the superior and inferior points.

[0123] Fig. 3E shows the plenum chamber 2200 of Fig. 3B in position for use on a face. The sagittal plane of the plenum chamber 2200 generally coincides with the midsagittal plane of the face when the plenum chamber is in position for use. The mid-contact plane corresponds generally to the 'plane of the face' when the plenum chamber is in position for use. In Fig. 3E the plenum chamber 2200 is that of a nasal mask, and the superior point 2220 sits approximately on the sellion, while the inferior point 2230 sits on the lip superior.

[0124] Fig. 3F shows a patient interface having conduit headgear, in accordance with one form of the present technology. 3.4 RPT DEVICE

[0125] Fig. 4A shows an RPT device in accordance with one form of the present technology.

[0126] Fig. 4B is a schematic diagram of the pneumatic path of an RPT device in accordance with one form of the present technology. The directions of upstream and downstream are indicated with reference to the blower and the patient interface. The blower is defined to be upstream of the patient interface and the patient interface is defined to be downstream of the blower, regardless of the actual flow direction at any particular moment. Items which are located within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0127] Fig. 4C is a schematic diagram of the electrical components of an RPT device in accordance with one form of the present technology.

[0128] Fig. 4C-1 is a schematic diagram illustrating the interconnection of various electrical components of the RPT device. 3.5 HUMIDIFIER

[0129] Fig. 5A shows an isometric view of a humidifier in accordance with one form of the present technology.

[0130] Fig. 5B shows an isometric view of a humidifier in accordance with one form of the present technology, showing a humidifier reservoir 4110 removed from the humidifier reservoir dock 4130. A2578192 12.0 21

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3.6 BREATHING WAVEFORMS

[0131] Fig. 6 shows a model typical breath waveform of a person while sleeping.

3.7 FEEDBACK SYSTEM

[0132] Fig. 7 shows a block diagram illustrating the components of a monitoring system for providing feedback to patient during respiratory therapy and/or on sleep characteristic(s).

4 DETAILED DESCRIPTION OF EXAMPLES OF THE

TECHNOLOGY

[0133] Before the present technology is described in further detail, it is to be understood that the technology is not limited to the particular examples described herein, which may vary. It is also to be understood that the terminology used in this disclosure is for the purpose of describing only the particular examples discussed herein, and is not intended to be limiting.

[0134] The following description is provided in relation to various examples which may share one or more common characteristics and/or features. It is to be understood that one or more features of any one example may be combinable with one or more features of another example or other examples. In addition, any single feature or combination of features in any of the examples may constitute a further example. 4.1 THERAPY

[0135] In one form, the present technology comprises a method for treating a respiratory disorder comprising applying positive pressure to the entrance of the airways of a patient 1000.

[0136] In certain examples of the present technology, a supply of air at positive pressure is provided to the nasal passages of the patient via one or both nares.

[0137] In certain examples of the present technology, mouth breathing is limited, restricted or prevented. 4.2 RESPIRATORY THERAPY SYSTEMS

[0138] In one form, the present technology comprises a respiratory therapy system for treating a respiratory disorder. The respiratory therapy system may

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20913400_1 (GHMatters) P120887.AU.1 comprise an RPT device 3000 for supplying a flow of air to the patient 1000 via an air circuit 3170 and a patient interface 2000 or 2800. 4.3 PATIENT INTERFACE

[0139] A non-invasive patient interface 2000, such as that shown in Fig. 3A, in accordance with one aspect of the present technology comprises the following functional aspects: a seal-forming structure 2100, a plenum chamber 2200, a positioning and stabilising structure 2300, a vent 2400, one form of connection port 2600 for connection to air circuit 3170, and a forehead support 2700. In some forms a functional aspect may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use the seal-forming structure 2100 is arranged to surround an entrance to the airways of the patient so as to maintain positive pressure at the entrance(s) to the airways of the patient 1000. The sealed patient interface 2000 is therefore suitable for delivery of positive pressure therapy.

[0140] The patient interface 2000 in accordance with one form of the present technology is constructed and arranged to be able to provide a supply of air at a positive pressure above the ambient, for example at least 2, 4, 6, 10, or 20 cmH20 with respect to ambient. 4.3.1 Seal-forming structure

[0141] In one form of the present technology, a seal-forming structure 2100 provides a target seal-forming region, and may additionally provide a cushioning function. The target seal-forming region is a region on the seal-forming structure 2100 where sealing may occur. The region where sealing actually occurs- the actual sealing surface- may change within a given treatment session, from day to day, and from patient to patient, depending on a range of factors including for example, where the patient interface was placed on the face, tension in the positioning and stabilising structure and the shape of a patient's face.

[0142] In one form the target seal-forming region is located on an outside surface of the seal-forming structure 2100.

[0143] In certain forms of the present technology, the seal-forming structure 2100 is constructed from a biocompatible material, e.g. silicone rubber.

[0144] A seal-forming structure 2100 in accordance with the present technology may be constructed from a soft, flexible, resilient material such as silicone.

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[0145] In certain forms of the present technology, a system is provided comprising more than one a seal-forming structure 2100, each being configured to correspond to a different size and/or shape range. For example the system may comprise one form of a seal-forming structure 2100 suitable for a large sized head, but not a small sized head and another suitable for a small sized head, but not a large sized head. 4.3.1.1 Sealing mechanisms

[0146] In one form, the seal-forming structure includes a sealing flange utilizing a pressure assisted sealing mechanism. In use, the sealing flange can readily respond to a system positive pressure in the interior of the plenum chamber 2200 acting on its underside to urge it into tight sealing engagement with the face. The pressure assisted mechanism may act in conjunction with elastic tension in the positioning and stabilising structure.

[0147] In one form, the seal-forming structure 2100 comprises a sealing flange and a support flange. The sealing flange comprises a relatively thin member with a thickness of less than about 1mm, for example about 0.25mm to about 0.45mm, which extends around the perimeter of the plenum chamber 2200. Support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the marginal edge of the plenum chamber 2200, and extends at least part of the way around the perimeter. The support flange is or includes a spring like element and functions to support the sealing flange from buckling in use.

[0148] In one form, the seal-forming structure may comprise a compression sealing portion or a gasket sealing portion. In use the compression sealing portion, or the gasket sealing portion is constructed and arranged to be in compression, e.g. as a result of elastic tension in the positioning and stabilising structure.

[0149] In one form, the seal-forming structure comprises a tension portion. In use, the tension portion is held in tension, e.g. by adjacent regions of the sealing flange.

[0150] In one form, the seal-forming structure comprises a region having a tacky or adhesive surface.

[0151] In certain forms of the present technology, a seal-forming structure may comprise one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having a tacky or adhesive surface. A2578192 12.0 24

20913400_1 (GHMatters) P120887.AU.1

4.3.1.2 Nose bridge or nose ridge region

[0152] In one form, the non-invasive patient interface 2000 comprises a seal forming structure that forms a seal in use on a nose bridge region or on a nose-ridge region of the patient's face.

[0153] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal in use on a nose bridge region or on a nose-ridge region of the patient's face. 4.3.1.3 Upper lip region

[0154] In one form, the non-invasive patient interface 2000 comprises a seal forming structure that forms a seal in use on an upper lip region (that is, the lip superior) of the patient's face.

[0155] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal in use on an upper lip region of the patient's face. 4.3.1.4 Chin-region

[0156] In one form the non-invasive patient interface 2000 comprises a seal forming structure that forms a seal in use on a chin-region of the patient's face.

[0157] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal in use on a chin-region of the patient's face. 4.3.1.5 Forehead region

[0158] In one form, the seal-forming structure that forms a seal in use on a forehead region of the patient's face. In such a form, the plenum chamber may cover the eyes in use. 4.3.1.6 Nasal pillows

[0159] In one form the seal-forming structure of the non-invasive patient interface 2000 comprises a pair of nasal puffs, or nasal pillows, each nasal puff or nasal pillow being constructed and arranged to form a seal with a respective naris of the nose of a patient.

[0160] Nasal pillows in accordance with an aspect of the present technology include: a frusto-cone, at least a portion of which forms a seal on an underside of the patient's nose, a stalk, a flexible region on the underside of the frusto-cone and connecting the frusto-cone to the stalk. In addition, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent the base of the stalk. The flexible regions can act in concert to facilitate a universal joint structure that is accommodating of relative movement both displacement and angular A2578192 12.0 25

20913400_1 (GHMatters) P120887.AU.1 of the frusto-cone and the structure to which the nasal pillow is connected. For example, the frusto-cone may be axially displaced towards the structure to which the stalk is connected. 4.3.1.7 Nose-only Masks

[0161] In one form, the patient interface 2000 comprises a seal-forming structure 2100 configured to seal around an entrance to the patient's nasal airways but not around the patient's mouth. The seal-forming structure 2100 may be configured to seal to the patient's lip superior. The patient interface 2000 may leave the patient's mouth uncovered. This patient interface 2000 may deliver a supply of air or breathable gas to both nares of patient 1000 and not to the mouth. This type of patient interface may be identified as a nose-only mask.

[0162] One form of nose-only mask according to the present technology is what has traditionally been identified as a "nasal mask", having a seal-forming structure 2100 configured to seal on the patient's face around the nose and over the bridge of the nose. A nasal mask may be generally triangular in shape. In one form, the non invasive patient interface 2000 comprises a seal-forming structure 2100 that forms a seal in use to an upper lip region (e.g. the lip superior), to the patient's nose bridge or at least a portion of the nose ridge above the pronasale, and to the patient's face on each lateral side of the patient's nose, for example proximate the patient's nasolabial sulci. The patient interface 2000 shown in Fig. 1B has this type of seal-forming structure 2100. This patient interface 2000 may deliver a supply of air or breathable gas to both nares of patient 1000 through a single orifice.

[0163] Another form of nose-only mask may seal around an inferior periphery of the patient's nose without engaging the user's nasal ridge. This type of patient interface 2000 may be identified as a "nasal cradle" mask and the seal-forming structure 2100 may be identified as a "nasal cradle cushion", for example. In one form, for example as shown in Fig. 3F, the seal-forming structure 2100 is configured to form a seal in use with inferior surfaces of the nose around the nares. The seal forming structure 2100 may be configured to seal around the patient's nares at an inferior periphery of the patient's nose including to an inferior and/or anterior surface of a pronasale region of the patient's nose and to the patient's nasal alae. The seal forming structure 2100 may seal to the patient's lip superior. The shape of the seal forming structure 2100 may be configured to match or closely follow the underside of the patient's nose and may not contact a nasal bridge region of the patient's nose or A2578192 12.0 26

20913400_1 (GHMatters) P120887.AU.1 any portion of the patient's nose superior to the pronasale. In one form of nasal cradle cushion, the seal-forming structure 2100 comprises a bridge portion dividing the opening into two orifices, each of which, in use, supplies air or breathable gas to a respective one of the patient's nares. The bridge portion may be configured to contact or seal against the patient's columella in use. Alternatively, the seal-forming structure 2100 may comprise a single opening to provide a flow or air or breathable gas to both of the patient's nares.

[0164] In some forms, a nose-only mask may comprise nasal pillows, described above. 4.3.1.8 Nose and Mouth Masks

[0165] In one form, the patient interface 2000 comprises a seal-forming structure 2100 configured to seal around an entrance to the patient's nasal airways and also around the patient's mouth. The seal-forming structure 2100 may be configured to seal to the patient's face proximate a chin region. This patient interface 2000 may deliver a supply of air or breathable gas to both nares and to the mouth of patient 1000. This type of patient interface may be identified as a nose and mouth mask.

[0166] One form of nose-and-mouth mask according to the present technology is what has traditionally been identified as a "full-face mask", having a seal-forming structure 2100 configured to seal on the patient's face around the nose, below the mouth and over the bridge of the nose. A nose-and-mouth mask may be generally triangular in shape. In one form the patient interface 2000 comprises a seal-forming structure 2100 that forms a seal in use to a patient's chin-region (which may include the patient's lip inferior and/or a region directly inferior to the lip inferior), to the patient's nose bridge or at least a portion of the nose ridge superior to the pronasale, and to cheek regions of the patient's face. The patient interface 2000 shown in Fig. IC is of this type. This patient interface 2000 may deliver a supply of air or breathable gas to both nares and mouth of patient 1000 through a single orifice. This type of seal forming structure 2100 may be referred to as a "nose-and-mouth cushion".

[0167] In another form the patient interface 2000 comprises a seal-forming structure 2100 that forms a seal in use on a patient's chin region (which may include the patient's lip inferior and/or a region directly inferior to the lip inferior), to an inferior and/or an anterior surface of a pronasale portion of the patient's nose, to the alae of the patient's nose and to the patient's face on each lateral side of the patient's nose, for example proximate the nasolabial sulci. The seal-forming structure 2100 A2578192 12.0 27

20913400_1 (GHMatters) P120887.AU.1 may also form a seal against a patient's lip superior. A patient interface 2000 having this type of seal-forming structure may have a single opening configured to deliver a flow of air or breathable gas to both nares and mouth of a patient, may have an oral hole configured to provide air or breathable gas to the mouth and a nasal hole configured to provide air or breathable gas to the nares, or may have an oral hole for delivering air to the patient's mouth and two nasal holes for delivering air to respective nares. This type of patient interface 2000 may have a nasal portion and an oral portion, the nasal portion sealing to the patient's face at similar locations to a nasal cradle mask.

[0168] In a further form of nose and mouth mask, the patient interface 2000 may comprise a seal-forming structure 2100 having a nasal portion comprising nasal pillows and an oral portion configured to form a seal to the patient's face around the patient's mouth.

[0169] In some forms, the seal-forming structure 2100 may have a nasal portion that is separate and distinct from an oral portion. In other forms, a seal-forming structure 2100 may form a contiguous seal around the patient's nose and mouth.

[0170] It is to be understood that the above examples of different forms of patient interface 2000 do not constitute an exhaustive list of possible configurations. In some forms a patient interface 2000 may comprise a combination of different features of the above described examples of nose-only and nose and mouth masks. 4.3.2 Plenum chamber

[0171] The plenum chamber 2200 has a perimeter that is shaped to be complementary to the surface contour of the face of an average person in the region where a seal will form in use. In use, a marginal edge of the plenum chamber 2200 is positioned in close proximity to an adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 2100. The seal-forming structure 2100 may extend in use about the entire perimeter of the plenum chamber 2200. In some forms, the plenum chamber 2200 and the seal-forming structure 2100 are formed from a single homogeneous piece of material.

[0172] In certain forms of the present technology, the plenum chamber 2200 does not cover the eyes of the patient in use. In other words, the eyes are outside the pressurised volume defined by the plenum chamber. Such forms tend to be less obtrusive and / or more comfortable for the wearer, which can improve compliance with therapy. A2578192 12.0 28

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[0173] In certain forms of the present technology, the plenum chamber 2200 is constructed from a transparent material, e.g. a transparent polycarbonate. The use of a transparent material can reduce the obtrusiveness of the patient interface, and help improve compliance with therapy. The use of a transparent material can aid a clinician to observe how the patient interface is located and functioning.

[0174] In certain forms of the present technology, the plenum chamber 2200 is constructed from a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface, and help improve compliance with therapy.

[0175] In some forms, the plenum chamber 2200 is constructed from a rigid material such as polycarbonate. The rigid material may provide support to the seal forming structure.

[0176] In some forms, the plenum chamber 2200 is constructed from a flexible material (e.g., constructed from a soft, flexible, resilient material like silicone, textile, foam, etc.). For example, in examples then may be formed from a material which has a Young's modulus of 0.4 GPa or lower, for example foam. In some forms of the technology the plenum chamber 2200 may be made from a material having Young's modulus of 0.1GPa or lower, for example rubber. In other forms of the technology the plenum chamber 2200 may be made from a material having a Young's modulus of 0.7MPa or less, for example between 0.7MPa and 0.3MPa. An example of such a material is silicone. 4.3.3 Positioning and stabilising structure

[0177] The seal-forming structure 2100 of the patient interface 2000 of the present technology may be held in sealing position in use by the positioning and stabilising structure 2300. The positioning and stabilising structure 2300 may comprise and function as "headgear" since it engages the patient's head in order to hold the patient interface 2000 in a sealing position. Examples of a positioning and stabilising structure may be shown in Fig. 3A.

[0178] In one form the positioning and stabilising structure 2300 provides a retention force at least sufficient to overcome the effect of the positive pressure in the plenum chamber 2200 to lift off the face (i.e., Fpienum).

[0179] In one form the positioning and stabilising structure 2300 provides a retention force to overcome the effect of the gravitational force on the patient interface 2000.

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[0180] In one form of the present technology, a positioning and stabilising structure 2300 comprises a strap constructed from a laminate of a fabric patient contacting layer, a foam inner layer and a fabric outer layer. In one form, the foam is porous to allow moisture, (e.g., sweat), to pass through the strap. In one form, the fabric outer layer comprises loop material to engage with a hook material portion.

[0181] In certain forms of the present technology, a positioning and stabilising structure 2300 comprises a strap that is extensible, e.g. resiliently extensible. For example the strap may be configured in use to be in tension, and to direct a force to draw a seal-forming structure into sealing contact with a portion of a patient's face. In an example the strap may be configured as a tie.

[0182] In one form of the present technology, the positioning and stabilising structure comprises a first tie, the first tie being constructed and arranged so that in use at least a portion of an inferior edge thereof passes superior to an otobasion superior of the patient's head and overlays a portion of a parietal bone without overlaying the occipital bone.

[0183] In one form of the present technology suitable for a nasal-only mask or for a full-face mask, the positioning and stabilising structure includes a second tie, the second tie being constructed and arranged so that in use at least a portion of a superior edge thereof passes inferior to an otobasion inferior of the patient's head and overlays or lies inferior to the occipital bone of the patient's head.

[0184] In one form of the present technology suitable for a nasal-only mask or for a full-face mask, the positioning and stabilising structure includes a third tie that is constructed and arranged to interconnect the first tie and the second tie to reduce a tendency of the first tie and the second tie to move apart from one another.

[0185] In certain forms of the present technology, a positioning and stabilising structure 2300 comprises a strap that is bendable and e.g. non-rigid. An advantage of this aspect is that the strap is more comfortable for a patient to lie upon while the patient is sleeping.

[0186] In certain forms of the present technology, a positioning and stabilising structure 2300 comprises a strap constructed to be breathable to allow moisture vapour to be transmitted through the strap,

[0187] In certain forms of the present technology, a system is provided comprising more than one positioning and stabilising structure 2300, each being configured to provide a retaining force to correspond to a different size and/or shape A2578192 12.0 30

20913400_1 (GHMatters) P120887.AU.1 range. For example the system may comprise one form of positioning and stabilising structure 2300 suitable for a large sized head, but not a small sized head, and another. suitable for a small sized head, but not a large sized head. 4.3.3.1 Conduit headgear 4.3.3.1.1 Conduit headgear tubes

[0188] In some forms of the present technology, the positioning and stabilising structure 2300 comprises one or more headgear tubes 2350 that deliver pressurised air received from a conduit forming part of the air circuit 3170 from the RPT device to the patient's airways, for example through the plenum chamber 2200 and seal forming structure 2100. In the form of the present technology illustrated in Fig. 3F, the positioning and stabilising structure 2300 comprises two tubes 2350 that deliver air to the plenum chamber 2200 from the air circuit 3170. The tubes 2350 are configured to position and stabilise the seal-forming structure 2100 of the patient interface 2000 at the appropriate part of the patient's face (for example, the nose and/or mouth) in use. This allows the conduit of air circuit 3170 providing the flow of pressurised air to connect to a connection port 2600 of the patient interface in a position other than in front of the patient's face, for example on top of the patient's head.

[0189] In the form of the present technology illustrated in Fig. 3F, the positioning and stabilising structure 2300 comprises two tubes 2350, each tube 2350 being positioned in use on a different side of the patient's head and extending across the respective cheek region, above the respective ear (superior to the otobasion superior on the patient's head) to the elbow 2610 on top of the head of the patient 1000. This form of technology may be advantageous because, if a patient sleeps with their head on its side and one of the tubes 2350 is compressed to block or partially block the flow of gas along the tube 2350, the other tube 2350 remains open to supply pressurised gas to the patient. In other examples of the technology, the patient interface 2000 may comprise a different number of tubes, for example one tube, or two or more tubes.

[0190] In one example in which the patient interface has one tube 2350, the single tube 2350 is positioned on one side of the patient's head in use (e.g. across one cheek region) and a strap forms part of the positioning and stabilising structure 2300 and is positioned on the other side of the patient's head in use (e.g. across the other region) to assist in securing the patient interface 2000 on the patient's head. For A2578192 12.0 31

20913400_1 (GHMatters) P120887.AU.1 example, the tube 2350 and the strap may each be under tension in use in order to assist in maintaining the seal-forming structure 2100 in a sealing position.

[0191] In one form, the tube 2350 may be at least partially extensible so that the tube 2350 and the strap may adjust substantially equal lengths when worn by a patient. This may allow for substantially symmetrical adjustments between the tube 2350 and the strap so that the seal-forming structure remains substantially in the middle.

[0192] In the form of the technology shown in Fig. 3F, the two tubes 2350 are fluidly connected at superior ends to each other and to the connection port 2600. In some examples, the two tubes 2350 are integrally formed while in other examples the tubes 2350 are formed separately but are connected in use and may be disconnected, for example for cleaning or storage. Where separate tubes are used, they may be indirectly connected together, for example each may be connected to a T-shaped connector. The T-shaped connector may have two arms/branches each fluidly connectable to a respective one of the tubes 2350. Additionally, the T-shaped connector may have a third arm or opening providing the connection port 2600 for fluid connection to the air circuit 3170 in use. The opening may be an inlet 2332 (see e.g., 7C) for receiving the flow of pressurized air.

[0193] In some forms, the third arm of the T-shaped connector may be substantially perpendicular to each of the first two arms.

[0194] In some forms, the third arm of the T-shaped connector may be obliquely formed with respect to each of the first two arms.

[0195] In some forms, a Y-shaped connector may be used instead of the T-shaped connector. The first two arms may be oblique with respect to one another, and the third arm may be oblique with respect to the first two arms. The angled formation of the first two arms may be similar to the shape of the patient's head in order to conform to the shape.

[0196] In some forms, at least one of the arms of the T-shaped connector (or Y shaped connector) may be flexible. This may allow the connector to bend based on the shape of the patient's head and/or a force in the positioning and stabilising structure 2300.

[0197] In some forms, at least one of the arms of the T-shaped connector (or Y shaped connector) may be at least partially rigidised. This may assist in maintaining

A2578192 12.0 32

20913400_1 (GHMatters) P120887.AU.1 the shape of the connector so that bending of the connector does not close the airflow path.

[0198] The tubes 2350 may be formed from a flexible material, such as an elastomer, e.g. silicone or TPE, and/or from one or more textile and/or foam materials. The tubes 2350 may have a preformed shape and may be able to be bent or moved into another shape upon application of a force but may return to the original preformed shape in the absence of said force. The tubes 2350 may be generally arcuate or curved in a shape approximating the contours of a patient's head between the top of the head and the nasal or oral region.

[0199] In some examples, the one or more tubes 2350 are crush resistant to resist being blocked if crushed during use, for example if squashed between a patient's head and pillow, especially if there is only one tube 2350. The tubes 2350 may be formed with a sufficient structural stiffness to resist crushing or may be as described in US Patent No. 6,044,844, the contents of which are incorporated herein by reference.

[0200] Each tube 2350 may be configured to receive a flow of air from the connection port 2600 on top of the patient's head and to deliver the flow of air to the seal-forming structure 2100 at the entrance of the patient's airways. In the example shown in Fig. 3F, each tube 2350 lies in use on a path extending from the plenum chamber 2200 across the patient's cheek region and superior to the patient's ear to the elbow 2610. For example, a portion of each tube 2350 proximate the plenum chamber 2200 may overlie a maxilla region of the patient's head in use. Another portion of each tube 2350 may overlie a region of the patient's head superior to an otobasion superior of the patient's head. Each of the tubes 2350 may also lie over the patient's sphenoid bone and/or temporal bone and either or both of the patient's frontal bone and parietal bone. The elbow 2610 may be located in use over the patient's parietal bone, over the frontal bone and/or over the junction therebetween (e.g. the coronal suture).

[0201] In certain forms of the present technology the patient interface 2000 is configured such that the connection port 2600 can be positioned in a range of positions across the top of the patient's head so that the patient interface 2000 can be positioned as appropriate for the comfort or fit of an individual patient. In some examples, the headgear tubes 2350 are configured to allow movement of an upper portion of the patient interface 2000 (e.g. a connection port 2600) with respect to a lower portion of the patient interface 2000 (e.g. a plenum chamber 2200). That is, the A2578192 12.0 33

20913400_1 (GHMatters) P120887.AU.1 connection port 2600 may be at least partially decoupled from the plenum chamber 2200. In this way, the seal-forming structure 2100 may form an effective seal with the patient's face irrespective of the position of the connection port 2600 (at least within a predetermined range of positions) on the patient's head.

[0202] As described above, in some examples of the present technology the patient interface 2000 comprises a seal-forming structure 2100 in the form of a cradle cushion which lies generally under the nose and seals to an inferior periphery of the nose (e.g. an under-the-nose cushion). The positioning and stabilising structure 2300, including the tubes 2350 may be structured and arranged to pull the seal-forming structure 2100 into the patient's face under the nose with a sealing force in a posterior and superior direction (e.g. a posterosuperior direction). A sealing force with a posterosuperior direction may cause the seal-forming structure 2100 to form a good seal to both the inferior periphery of the patient's nose and anterior-facing surfaces of the patient's face, for example on either side of the patient's nose and the patient's lip superior.

4.3.3.1.2 Conduit headgear connection port

[0203] In certain forms of the present technology, the patient interface 2000 may comprise a connection port 2600 located proximal to a superior, lateral or posterior portion of a patient's head. For example, in the form of the present technology illustrated in Fig 3F, the connection port 2600 is located on top of the patient's head (e.g. at a superior location with respect to the patient's head). In this example the patient interface 2000 comprises an elbow 2610 forming the connection port 2600. The elbow 2610 may be configured to fluidly connect with a conduit of an air circuit 3170. The elbow 2610 may be configured to swivel with respect to the positioning and stabilising structure 2300 to at least partially decouple the conduit from the positioning and stabilising structure 2300. In some examples the elbow 2610 may be configured to swivel by rotation about a substantially vertical axis and, in some particular examples, by rotation about two or more axes. In some examples the elbow may comprise or be connected to the tubes 2350 by a ball-and-socket joint. The connection portion 2600 may be located in the sagittal plane of the patient's head in use.

[0204] Patient interfaces having a connection port that is not positioned anterior to the patient's face may be advantageous as some patients may find a conduit that A2578192 12.0 34

20913400_1 (GHMatters) P120887.AU.1 connects to a patient interface anterior to their face to be unsightly and/or obtrusive. For example, a conduit connecting to a patient interface anterior to the patient's face may be prone to interference with bedclothes or bed linen, particularly if the conduit extends inferiorly from the patient interface in use. Forms of the present technology comprising a patient interface having a connection port positioned superiorly to the patient's head in use may make it easier or more comfortable for a patient to lie or sleep in one or more of the following positions: a side-sleeping position, a supine position (e.g. on their back, facing generally upwards) or in a prone position (e.g. on their front, facing generally downwards). Moreover, connecting a conduit to an anterior portion of a patient interface may exacerbate a problem known as tube drag in which the conduit exerts an undesired force upon the patient interface during movement of the patient's head or the conduit, thereby causing dislodgement away from the face. Tube drag may be less of a problem when force is received at a superior location of the patient's head than anterior to the patient's face proximate to the seal-forming structure (where tube drag forces may be more likely to disrupt the seal). 4.3.3.1.3 Headgear Tube Fluid Connections

[0205] The two tubes 2350 are fluidly connected at their inferior ends to the plenum chamber 2200. In certain forms of the technology, the connection between the tubes 2350 and the plenum chamber 2200 is achieved by connection of two rigid connectors. The tubes 2350 and plenum chamber 2200 may be configured to enable the patient to easily connect the two components together in a reliable manner. The tubes 2350 and plenum chamber 2200 may be configured to provide tactile and/or audible feedback in the form of a 're-assuring click' or a similar sound, so that the patient may easily know that each tube 2350 has been correctly connected to the plenum chamber 2200. In one form, the tubes 2350 are formed from a silicone or textile material and the inferior end of each of the silicone tubes 2350 is overmolded to a rigid connector made, for example, from polypropylene, polycarbonate, nylon or the like. The rigid connector on each tube 2350 may comprise a female mating feature configured to connect with a male mating feature on the plenum chamber 2200. Alternatively, the rigid connector on each tube 2350 may comprise a male mating feature configured to connect to a female mating feature on the plenum chamber 2200. In other examples the tubes 2350 may each comprise a male or female

A2578192 12.0 35

20913400_1 (GHMatters) P120887.AU.1 connector formed from a flexible material, such as silicone or TPE, for example the same material from which the tubes 2350 are formed.

[0206] In other examples a compression seal is used to connect each tube 2350 to the plenum chamber 2200. For example, a resiliently flexible (e.g. silicone) tube 2350 without a rigid connector may be configured to be squeezed to reduce its diameter so that it can be compressed into a port in the plenum chamber 2200 and the inherent resilience of the silicone pushes the tube 2350 outwards to seal the tube 2350 in the port in an air-tight manner. Alternatively, in a hard-to-hard type engagement between the tube 2350 and the plenum chamber 2200, each tube 2350 and/or plenum chamber 2200 may comprise a pressure activated seal, for example a peripheral sealing flange. When pressurised gas is supplied through the tubes 2350 the sealing flange may be urged against the join between the tubes and a circumferential surface around a port or connector of the plenum chamber 2200 to form or enhance a seal between the tube 2350 and plenum chamber 2200. 4.3.3.2 Headgear straps

[0207] In some forms, the positioning and stabilising structure 2300 may include headgear 2302 with at least one strap which may be worn by the patient in order to assist in properly orienting the seal-forming structure 2100 against the patient's face (e.g., in order to limit or prevent leaks).

[0208] As described above, some forms of the headgear 2302 may be constructed from a textile material, which may be comfortable against the patient's skin. The textile may be flexible in order to conform to a variety of facial contours. Although the textile may include rigidisers along a selected length, which may limit bending, flexing, and/or stretching of the headgear 2302.

[0209] In certain forms, the headgear 2302 may be at least partially extensible. For example, the headgear 2302 may include elastic, or a similar extensible material. For example, the entire headgear 2302 may be extensible or selected portions may be extensible (or more extensible than surrounding portions). This may allow the headgear 2302 to stretch while under tension, which may assist in providing a sealing force for the seal-forming structure 2100.

[0210] Two forms of the headgear, four-point headgear 2302-1 (see Fig. 3A) and two-point headgear 2302-2 (see Fig. 3F).

A2578192 12.0 36

20913400_1 (GHMatters) P120887.AU.1

4.3.4 Vent

[0211] In one form, the patient interface 2000 includes a vent 2400 constructed and arranged to allow for the washout of exhaled gases, e.g. carbon dioxide.

[0212] In certain forms the vent 2400 is configured to allow a continuous vent flow from an interior of the plenum chamber 2200 to ambient whilst the pressure within the plenum chamber is positive with respect to ambient. The vent 2400 is configured such that the vent flow rate has a magnitude sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining the therapeutic pressure in the plenum chamber in use.

[0213] One form of vent 2400 in accordance with the present technology comprises a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0214] The vent 2400 may be located in the plenum chamber 2200. Alternatively, the vent 2400 is located in a decoupling structure, e.g., a swivel. 4.3.5 Decoupling structure(s)

[0215] In one form the patient interface 2000 includes at least one decoupling structure, for example, a swivel or a ball and socket. 4.3.6 Connection port

[0216] Connection port 2600 allows for connection to the air circuit 3170. 4.3.7 Forehead support

[0217] In one form, the patient interface 2000 includes a forehead support 2700. 4.3.8 Anti-asphyxia valve

[0218] In one form, the patient interface 2000 includes an anti-asphyxia valve. 4.3.9 Modularity

[0219] As described above, the cushion, headgear, and sleeves may come in different styles, which may correspond to different uses (e.g., mouth breathing, nasal breathing, etc.). A patient or clinician may select certain combinations of cushions, headgear, and sleeves in order to optimize the effectiveness of the therapy and/or the individual patient's comfort. An example of this sort of modular design is described in PCT/SG2022/050777 filed 28 October 2022, incorporated herein by reference in its entirety.

[0220] In some forms, the different styles of cushions, headgear, and sleeves may be used interchangeably with one another in order to form different combinations of patient interfaces. This may be beneficial from a manufacturing prospective because A2578192 12.0 37

20913400_1 (GHMatters) P120887.AU.1 wider variety of patient interfaces may be created using fewer parts. Additionally or alternatively, the various combinations may allow a patient to change styles of patient interface without changing the every component.

[0221] Air may be delivered to the patient in one of two main ways. In one example, the patient may receive the flow of pressurized air through headgear tubes 2350 (see e.g., Fig. 3F). This may be referred to as a "tube up" configuration and may position a connection port at the top of the patient's head. In other example, the patient may receive the flow of pressurized air through a conduit connected to the plenum chamber 2200, for example through the connection port 2600 (see e.g., Fig. 3A). This may be referred to a "tube down" configuration where the airflow conduit is positioned in front of the patient's face. Different patients may be more comfortable with one style of air delivery over the other (e.g., because of the patient's sleep style). Therefore, it may be beneficial to allow a single style of patient interface to be used in either the "tube up" or "tube down" configuration.

[0222] The patient interface may be part of a modular assembly with a variety of interchangeable components that may be swapped out by a patient and/or clinician for one or more components for a different style. The following description describes the various combinations that may be created by assembling the different components together. 4.4 RPT DEVICE

[0223] An RPT device 3000 in accordance with one aspect of the present technology comprises mechanical, pneumatic, and/or electrical components and is configured to execute one or more algorithms 3300, such as any of the methods, in whole or in part, described herein. The RPT device 3000 may be configured to generate a flow of air for delivery to a patient's airways, such as to treat one or more of the respiratory conditions described elsewhere in the present document.

[0224] The RPT device may have an external housing 3010, formed in two parts, an upper portion 3012 and a lower portion 3014. Furthermore, the external housing 3010 may include one or more panel(s) 3015. The RPT device 3000 comprises a chassis 3016 that supports one or more internal components of the RPT device 3000. The RPT device 3000 may include a handle 3018.

[0225] The pneumatic path of the RPT device 3000 may comprise one or more air path items, e.g., an inlet airfilter 3112, an inlet muffler 3122, a pressure generator 3140 capable of supplying air at positive pressure (e.g., a blower 3142), an outlet A2578192 12.0 38

20913400_1 (GHMatters) P120887.AU.1 muffler 3124 and one or more transducers 3270, such as pressure sensors 3272 and flow rate sensors 3274.

[0226] One or more of the air path items may be located within a removable unitary structure which will be referred to as a pneumatic block 3020. The pneumatic block 3020 may be located within the external housing 3010. In one form a pneumatic block 3020 is supported by, or formed as part of the chassis 3016.

[0227] As shown in Fig. 4C, the RPT device 3000 may have an electrical power supply 3210, one or more input devices 3220, a central controller 3230, a therapy device controller 3240, a pressure generator 3140, one or more protection circuits 3250, memory 3260, transducers 3270, data communication interface 3280 and one or more output devices 3290. Electrical components 3200 may be mounted on a single Printed Circuit Board Assembly (PCBA) 3202. In an alternative form, the RPT device 3000 may include more than one PCBA 3202. 4.4.1 RPT device mechanical & pneumatic components

[0228] An RPT device may comprise one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be located as respective separate units. 4.4.1.1 Air filter(s)

[0229] An RPT device in accordance with one form of the present technology may include an air filter 3110, or a plurality of air filters 3110.

[0230] In one form illustrated in Fig. 4B, an inlet air filter 3112 is located at the beginning of the pneumatic path upstream of a pressure generator 3140.

[0231] In one form illustrated in Fig. 4B, an outlet air filter 3114, for example an antibacterial filter, is located between an outlet of the pneumatic block 3020 and a patient interface 2000 or 2800. 4.4.1.2 Muffler(s)

[0232] An RPT device in accordance with one form of the present technology may include a muffler 3120, or a plurality of mufflers 3120.

[0233] In one form of the present technology (see e.g., Fig. 4B), an inlet muffler 3122 is located in the pneumatic path upstream of a pressure generator 3140.

[0234] In one form of the present technology, an outlet muffler 3124 is located in the pneumatic path between the pressure generator 3140 and a patient interface 2000 or 2800.

A2578192 12.0 39

20913400_1 (GHMatters) P120887.AU.1

4.4.1.3 Pressure generator

[0235] In one form of the present technology, a pressure generator 3140 for producing a flow, or a supply, of air at positive pressure is a controllable blower 3142. For example, the blower 3142 may include a brushless DC motor 3144 with one or more impellers. The impellers may be located in a volute. The blower may be capable of delivering a supply of air, for example at a rate of up to about 120 litres/minute, at a positive pressure in a range from about 4 cmH20 to about 20 cmH20, or in other forms up to about 30 cmH20 when delivering respiratory pressure therapy. The blower may be as described in any one of the following patents or patent applications the contents of which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO 2013/020167.

[0236] The pressure generator 3140 may be under the control of the therapy device controller 3240.

[0237] In other forms, a pressure generator 3140 may be a piston-driven pump, a pressure regulator connected to a high pressure source (e.g. compressed air reservoir), or a bellows. 4.4.1.4 Transducer(s)

[0238] Transducers may be internal of the RPT device, or external of the RPT device. External transducers may be located for example on or form part of the air circuit, e.g., the patient interface. External transducers may be in the form of non contact sensors such as a Doppler radar movement sensor that transmit or transfer data to the RPT device.

[0239] In one form of the present technology (see e.g., Fig. 4B), one or more transducers 3270 are located upstream and/or downstream of the pressure generator 3140. The one or more transducers 3270 may be constructed and arranged to generate signals representing properties of the flow of air such as a flow rate, a pressure or a temperature at that point in the pneumatic path.

[0240] In one form of the present technology, one or more transducers 3270 may be located proximate to the patient interface 2000 or 2800.

[0241] In one form, a signal from a transducer 3270 may be filtered, such as by low-pass, high-pass or band-pass filtering.

A2578192 12.0 40

20913400_1 (GHMatters) P120887.AU.1

4.4.1.4.1 Flow rate sensor

[0242] A flow rate sensor 3274 in accordance with the present technology may be based on a differential pressure transducer, for example, an SDP600 Series differential pressure transducer from SENSIRION.

[0243] In one form, a signal generated by the flow rate sensor 3274 and representing a flow rate is received by the central controller 3230. 4.4.1.4.2 Pressure sensor

[0244] A pressure sensor 3272 in accordance with the present technology is located in fluid communication with the pneumatic path. An example of a suitable pressure sensor is a transducer from the HONEYWELL ASDX series. An alternative suitable pressure sensor is a transducer from the NPA Series from GENERAL ELECTRIC.

[0245] In one form, a signal generated by the pressure sensor 3272 and representing a pressure is received by the central controller 3230. 4.4.1.4.3 Motor speed transducer

[0246] In one form of the present technology a motor speed transducer 3276 is used to determine a rotational velocity of the motor 3144 and/or the blower 3142. A motor speed signal from the motor speed transducer 3276 may be provided to the therapy device controller 3240. The motor speed transducer 3276 may, for example, be a speed sensor, such as a Hall effect sensor. 4.4.1.5 Anti-spill back valve

[0247] As shown in Fig. 4B, one form of the present technology, an anti-spill back valve 3160 is located between the humidifier 4000 and the pneumatic block 3020. The anti-spill back valve is constructed and arranged to reduce the risk that water will flow upstream from the humidifier 4000, for example to the motor 3144. 4.4.2 RPT device electrical components 4.4.2.1 Power supply

[0248] A power supply 3210 may be located internal or external of the external housing 3010 of the RPT device 3000.

[0249] In one form of the present technology, power supply 3210 provides electrical power to the RPT device 3000 only. In another form of the present technology, power supply 3210 provides electrical power to both RPT device 3000 and humidifier 4000.

A2578192 12.0 41

20913400_1 (GHMatters) P120887.AU.1

[0250] As illustrated in Fig. 4C-1, the power supply 3210 may provide electrical power to the input device 3220, the central controller 3230, the output device 3290, and the pressure generator 3140. The power supply 3210 may also provide electric energy to other components of the RPT device 3000 (or the humidifier 4000, as described above). 4.4.2.2 Input devices

[0251] In one form of the present technology, an RPT device 3000 includes one or more input devices 3220 in the form of buttons, switches or dials to allow a person to interact with the device. The buttons, switches or dials may be physical devices, or software devices accessible via a touch screen. The buttons, switches or dials may, in one form, be physically connected to the external housing 3010, or may, in another form, be in wireless communication with a receiver that is in electrical connection to the central controller 3230.

[0252] In one form, the input device 3220 may be constructed and arranged to allow a person to select a value and/or a menu option. 4.4.2.3 Central controller

[0253] In one form of the present technology, the central controller 3230 is one or a plurality of processors suitable to control an RPT device 3000. The central controller 3230 is show in Figs. 4C and 4C-1.

[0254] Suitable processors may include an x86 INTEL processor, a processor based on ARM® Cortex@-M processor from ARM Holdings such as an STM32 series microcontroller from ST MICROELECTRONIC. In certain alternative forms of the present technology, a 32-bit RISC CPU, such as an STR9 series microcontroller from ST MICROELECTRONICS or a 16-bit RISC CPU such as a processor from the MSP430 family of microcontrollers, manufactured by TEXAS INSTRUMENTS may also be suitable.

[0255] In one form of the present technology, the central controller 3230 is a dedicated electronic circuit.

[0256] In one form, the central controller 3230 is an application-specific integrated circuit. In another form, the central controller 3230 comprises discrete electronic components.

[0257] The central controller 3230 may be configured to receive input signal(s) from one or more transducers 3270, one or more input devices 3220, and/or the humidifier 4000. A2578192 12.0 42

20913400_1 (GHMatters) P120887.AU.1

[0258] The central controller 3230 may be configured to provide output signal(s) to one or more of an output device 3290, a pressure generator 3140, a therapy device controller 3240, a data communication interface 3280, and/or the humidifier 4000.

[0259] In some forms of the present technology, the central controller 3230 is configured to implement the one or more methodologies described herein, such as the one or more algorithms 3300 which may be implemented with processor-control instructions, expressed as computer programs stored in a non-transitory computer readable storage medium, such as memory 3260. In some forms of the present technology, the central controller 3230 may be integrated with an RPT device 3000. However, in some forms of the present technology, some methodologies may be performed by a remotely located device. For example, the remotely located device may determine control settings for a ventilator or detect respiratory related events by analysis of stored data such as from any of the sensors described herein. 4.4.2.4 Clock

[0260] The RPT device 3000 may include a clock 3232 that is connected to the central controller 3230. 4.4.2.5 Therapy device controller

[0261] In one form of the present technology, therapy device controller 3240 is a therapy control module 3330 that forms part of the algorithms 3300 executed by the central controller 3230.

[0262] In one form of the present technology, therapy device controller 3240 is a dedicated motor control integrated circuit. For example, in one form a MC33035 brushless DC motor controller, manufactured by ONSEMI is used. 4.4.2.6 Protection circuits

[0263] The one or more protection circuits 3250 in accordance with the present technology may comprise an electrical protection circuit, a temperature and/or pressure safety circuit. 4.4.2.7 Memory

[0264] In accordance with one form of the present technology the RPT device 3000 includes memory 3260, e.g., non-volatile memory. In some forms, memory 3260 may include battery powered static RAM. In some forms, memory 3260 may include volatile RAM.

[0265] Memory 3260 may be located on the PCBA 3202. Memory 3260 may be in the form of EEPROM, or NAND flash. A2578192 12.0 43

20913400_1 (GHMatters) P120887.AU.1

[0266] Additionally, or alternatively, RPT device 3000 includes a removable form of memory 3260, for example a memory card made in accordance with the Secure Digital (SD) standard.

[0267] In one form of the present technology, the memory 3260 acts as a non transitory computer readable storage medium on which is stored computer program instructions expressing the one or more methodologies described herein, such as the one or more algorithms 3300. 4.4.2.8 Data communication systems

[0268] In one form of the present technology, a data communication interface 3280 is provided, and is connected to the central controller 3230 (see e.g., Fig. 4C). Data communication interface 3280 may be connectable to a remote external communication network 3282 and/or a local external communication network 3284. The remote external communication network 3282 may be connectable to a remote external device 3286. The local external communication network 3284 may be connectable to a local external device 3288.

[0269] In one form, data communication interface 3280 is part of the central controller 3230. In another form, data communication interface 3280 is separate from the central controller 3230, and may comprise an integrated circuit or a processor.

[0270] In one form, remote external communication network 3282 is the Internet. The data communication interface 3280 may use wired communication (e.g. via Ethernet, or optical fibre) or a wireless protocol (e.g. CDMA, GSM, LTE) to connect to the Internet.

[0271] In one form, local external communication network 3284 utilises one or more communication standards, such as Bluetooth, or a consumer infrared protocol.

[0272] In one form, remote external device 3286 is one or more computers, for example a cluster of networked computers. In one form, remote external device 3286 may be virtual computers, rather than physical computers. In either case, such a remote external device 3286 may be accessible to an appropriately authorised person such as a clinician.

[0273] The local external device 3288 may be a personal computer, mobile phone, tablet or remote control.

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4.4.2.9 Output devices including optional display, alarms

[0274] An output device 3290 in accordance with the present technology may take the form of one or more of a visual, audio and haptic unit. A visual display may be a Liquid Crystal Display (LCD) or Light Emitting Diode (LED) display. 4.4.2.9.1 Display driver

[0275] A display driver 3292 receives as an input the characters, symbols, or images intended for display on the display 3294, and converts them to commands that cause the display 3294 to display those characters, symbols, or images. 4.4.2.9.2 Display

[0276] A display 3294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 3292. For example, the display 3294 may be an eight-segment display, in which case the display driver 3292 converts each character or symbol, such as the figure "0", to eight logical signals indicating whether the eight respective segments are to be activated to display a particular character or symbol.

4.5 FEEDBACK FOR ASSISTING SLEEP CONDITIONS

[0277] Referring now to Fig. 7, a feedback system 5000 may be provided to assist a patient with a sleep condition such as undergoing respiratory therapy or experiencing sleep disorder including SBD. The system 5000 may be configured to collect and analyse data from at least one computing device 5002 associated with the patient, and communicate e.g., observations, advice etc., to the patient regarding their respiratory therapy and/or characteristics of their sleep.

[0278] For example, the system may provide the patient with an indication of: their sleep performance (i.e., how the effectively the patient sleeps, e.g., duration of sleep, interruptions during sleeping period, etc) during respiratory therapy, e.g., a PAP therapy 'coach'; status of their sleep hygiene (i.e., habits relating to sleep, e.g., mobile phone usage prior to sleep, irregular bed times, poor diet, etc.); potential underlying/ undiagnosed sleeping disorders, e.g., insomnia; etc.

[0279] As shown in Fig. 7, a block diagram illustrates the components of the feedback system 5000. The system 5000 may be embodied/ implemented in the at least one computing device 5002, which may include mobile devices 5002a, e.g., a A2578192 12.0 45

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'smart' phone, a wearable device such as a 'smart' watch, etc.; or in a respiratory pressure therapy (RPT) device 5002b. In other forms, the system 5000 may be implemented in a server, a personal computer or any suitable device or devices.

[0280] In either of the forms 5002a,5002b set forth above, the system 5000 may be configured for use with the respiratory therapy system comprising the RPT device 5002b (i.e., a flow generator) for generating a flow of air to be delivered to a patient interface for respiratory therapy. In this regard, the feedback system 5000 comprises at least the RPT device as the at least one computing device. In other forms, the feedback system may be used as a standalone system providing feedback on characteristics of a user's sleep and associated factors that may impact sleep.

[0281] The feedback system 5000 embodied in the computing device may also comprise a memory 5006 storing machine-readable instructions and a computing system 5004 having one or more processors for executing the machine-readable instructions to perform one or more functions. As set forth in more detail later, the one or more functions implement a feedback process, i.e., a 'patient feedback process' to assist the patient under respiratory therapy.

[0282] In some forms, the feedback process may include adjustment of a delivery of respiratory therapy, e.g., pressure, flow rate, etc. For example, in a patient having SDB and wearing a patient interface, a detection of abnormal breathing may be indicative of a sleep apnoea, whereby the RPT device, i.e., a flow generator, may be used to adjust respiratory therapy, e.g., pressure, flow, etc., for stimulating a change in the patient's breathing.

[0283] The system 5000 may also comprise a user interface 5008 to display/ output alerts or feedback for e.g., communicating information to the patient; a user control/input 5010 such as a touch panel, control buttons, etc.; and one or more sensors 5012 configured to generate sensor data associated with the patient under respiratory therapy, i.e., for sensing particular properties related to a physiology of the patient. The user interface 5008 may also be used to input data manually by the patient (rather than rely on sensors). This may be subjective data, such as manual ratings on wellbeing or other patient traits, or could be more quantitative data, such as a log of food and/or drink consumed, or to confirm activities that have been sensed. A2578192 12.0 46

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Guided user input screens may be provided to assist in this process and to more systematically capture the patient data.

[0284] As set forth above, the feedback system 5000 may be embodied in one or more computing devices: a mobile device 5002a and/ or an RPT device 5002b. As such, the components of the system 5000, i.e., processors, display, input, sensors, etc., may be those of the computing device 5002. That is, the feedback system 5000 may utilise i.e., 'share' the components of the computing devices. For example, the system 5000 may utilise sensors of a mobile device, e.g., motion sensors, light sensors, etc, to collect data about the patient to thereby communicate e.g., observations, advice etc., to the patient about e.g., their sleep behaviours in relation to their respiratory therapy.

[0285] The system 5000 may further comprise one or more environmental sensors 5014 and/or consume data associated with third party sensors. The environmental sensors 5014 may be provided to measure properties of the patient's surrounding environment. For example, the environmental sensors may be of a type that measures changes in temperature, humidity, etc. In some forms, the environmental sensors may be located in an external computing device such as a room/home thermostat, home security systems, a 'home pod' etc.

[0286] As set forth in more detail later, the external computing device may be configured to adjust properties of the patient's surrounding environment based on instructions from the system 5000 and in response to the changes measured in e.g., the temperature, humidity, etc. For example, the external computing device may be coupled with an air conditioning unit for cooling a room of the patient when the sensors detect e.g., the temperature of the room as being too high.

[0287] In other forms, sensors of e.g., a mobile device, may be utilised to detect properties of the surrounding environment. Senor data recorded by the environmental sensors may be recorded and utilised together with sensor data recorded by e.g., the mobile device and RPT device.

[0288] The components of the system 5000 as set forth above, may be integrated with the computing device in software running on the computing device. In the form whereby a mobile phone is used, the system 5000 may be implemented via a software

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20913400_1 (GHMatters) P120887.AU.1 mobile application (i.e., an 'app'). In the form whereby an RPT device is used, the system 5000 may be implemented via software operated by the RPT device.

[0289] In either implementation of the system 5000 (i.e., via the mobile device or RPT device), the computing system 5004 may be configured to implement the patient feedback process by receiving sensor data and, together the one or more processors and memory 5006, determine one or more sleep characteristics of the patient. According to the one or more sleep characteristics determined, the computing system 5004 may generate a feedback response to be communicated to the patient.

[0290] The sensor data utilised (i.e., being received) by the computing system 5004 may be in relation to (i.e., generated from) the patient's respiratory therapy or be independent of the patient's respiratory therapy.

[0291] The sensor data relating to the patient's respiratory therapy may include data collected from e.g., pressure sensors, flow sensors, etc. Sensor data collected from such sensors may allow the computer system 5004 to determine e.g., a frequency of sleep apnoea events.

[0292] The sensor data generated with respect to the patient's respiratory therapy may be generated by sensors located on the RPT device 5002b and/ or the mobile device 5002a. In this regard, the sensors may measure and collect data relating to an operation of the RPT device, as well as measuring and collecting physiological data of the patient in relation to their respiratory therapy and/or environmental data that may impact sleep performance.

[0293] The computing system 5004 may also utilise sensor data that is not related to the patient's respiratory therapy. In this case, the sensor data may be independent of the patient's respiratory therapy and relate to a physiology of the patient, i.e., being independent patient related data.

[0294] In some cases, the patient related data may be collected by sensors 5012 configured to measure, e.g., the patient's body temperature. In other cases, the patient related data may be collected by environmental sensors 5014 configured to measure e.g., a temperature of the environment surrounding the patient. In this case, the

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20913400_1 (GHMatters) P120887.AU.1 temperature of the surrounding environment may influence the temperature of the patient.

[0295] As set forth in more detail later, the sensor data and the independent patient related data may be used by the computing system to determine sleep characteristics of the patient. These sleep characteristics may then be used by the feedback system 5000 as a sleep disorder diagnosis, a sleep assistant, to assist in acclimatising a patient to respiratory therapy and/or to assist the patient undergoing respiratory therapy. In this regard, the feedback system 5000 may operate as a kind of 'personal assistant' or 'coach' to provide feedback, i.e., for communicating information, to the patient based on their sleep characteristics. In effect, the 'personal assistant' or 'coach' may allow the patient to improve how they sleep. For example, the feedback system 5000 may be configured to advise the patient on ways to improve their use of the respiratory therapy system, and in some cases, advise the patient on ways they may improve how they sleep independently of their respiratory therapy, for e.g., improving sleep hygiene.

[0296] The feedback system 5000, i.e., the 'personal assistant' for respiratory therapy, may be configured for more than one type of application. In other words, the feedback system 5000 may be configured to provide a patient with more than one way of improving how they sleep. As set forth in more detail below, the feedback system 5000 may be configured to provide general advice to a patient in relation to management and ongoing 'personal assistance' with their respiratory therapy relating to a sleeping disorder. The feedback system 5000 may also be configured to provide general advice to a patient in relation to their sleep hygiene, sleep performance and, for some patients, for diagnosis of undiagnosed sleeping disorders.

[0297] Firstly, in some forms, the system 5000 may be configured to provide general advice to the patient relating to their sleep health. The advice may be directed to improving the efficacy of respiratory therapy such as PAP therapy or to assist in onboarding or acclimatising the patient to respiratory therapy. That is, the system may provide the patient with information based on data collected by sensors 5012,5014 that may assist the patient to 'get to sleep' and/or when asleep, to improve the quality of that sleep.

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[0298] For example, if the patient has particular habits that may hinder their capacity to fall asleep, or maintain sufficient sleep e.g., during a night-time, the system 5000 may assist the patient to correct these particular habits. In a further example, the system 5000 may be configured to detect incorrect use of e.g., a patient interface which may impact the patient's sleep. In either case, the system 5000 in this form may be configured to provide general advice to the patient about the state/ status of their sleep health in view of improving the efficacy of their respiratory therapy.

[0299] In other forms, the system 5000 may additionally or alternatively be used as a type of diagnostic tool for sleep disorders. That is, the system 5000 may be configured to analyse data collected from the patient and identify indications of sleep disorders such as insomnia, etc, that may not have been previously diagnosed.

[0300] For example, in the case of a patient who has been tested for and diagnosed with OSA (but no other sleeping disorders), the system 5000 may be used to monitor the patient e.g., while they sleep, so as to determine (and advise) if they may have any undiagnosed/unidentified sleep disorders, e.g., insomnia. If the system detects indications of such a sleep disorder, the computing system 5004 may be configured to generate feedback to the patient advising of the potential condition and a suggested course of action. Such an alert may be provided to the patient via the user interface 5008 either on the RPT device, mobile device, etc.

[0301] In further forms of the feedback system 5000, the system may additionally or alternatively be configured to 'coach' a patient to improve, i.e., optimise, their use of respiratory therapy, e.g., PAP therapy. The system in this form may be configured to utilise the RPT device as a source of information, i.e., sensor data collected about the patient's respiratory therapy. This data may be analysed, i.e., processed to provide feedback on e.g., the patient's compliance to therapy, whereby the RPT device may be configured to inform the patient as to how they may improve their e.g., compliance, etc.

[0302] The system 5000 in this form may utilise data collected from sensors located on the RPT device, in addition to other devices (e.g., mobile phones, 'smart' watches, etc). In this regard, some forms of the system 5000 may comprise e.g., a mobile phone together with an RPT device, or alternatively, the system may utilise

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20913400_1 (GHMatters) P120887.AU.1 only one type of computing device, e.g., a mobile device or an RPT device alone. In forms where the RPT device is utilised together with e.g., a mobile device, the data collected from the RPT device and the mobile device may be analysed in combination to provide a more detailed assessment of the patient's sleep characteristics.

[0303] In forms where more than one computing device 5002a,5002b is used, the devices may also be coupled, i.e., configured to communicate with each other, to allow a pattern or routine of the patient to be determined. For at least this reason, utilising the mobile device together with the RPT device may be particularly advantageous for collecting patient data in relation to the efficacy of their respiratory therapy (and how their behaviours, e.g., sleep habits, etc may influence said efficacy).

[0304] In any case, i.e., where either one, or more than one, computing device is used, each of the computing devices may be configured to aggregate data relating to sleep characteristics, i.e., behaviours of the patient. For example, the patient may rely on e.g., the mobile phone as part of their everyday life (and may always be within reach) and as such, may allow an aggregate of data to be obtained from the patient e.g., over a period of days, weeks, etc. Advantageously, this information may be analysed to provide longitudinal information about the patient.

[0305] Use of the mobile device during everyday activities may allow the mobile device to record data about the patient during both waking hours and sleeping hours. Advantageously, such longitudinal data collection may provide valuable insights that cannot be gleaned from infrequent spot checks of e.g., the patient's physiology. For example, information may be provided about e.g., a patient's waking habits such as exercise, etc, that may be used to indicate risk factors for e.g., underlying sleep disorders.

[0306] The data collected by the one, or more than one, device may therefore be combined and analysed to indicate particular types of sleep characteristics such as sleep patterns or routines. These patterns or routines may be measured and collected by various means, as set forth in more detail below. In some forms, the system may be configured to use the sensors 5012,5014 to measure and collect data about the patient to determine such sleep characteristics. In other forms, the patient's usage of the computing devices, e.g., mobile phone, smart watch, etc., may be collected and

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20913400_1 (GHMatters) P120887.AU.1 analysed to indicate aspects of the patient's e.g., sleep habits that may affect their sleep and hence, the efficacy of their respiratory therapy.

[0307] Referring firstly to the use of sensors 5012,5014 to collect sensor data and patient related data. The sensors 5012 may be configured for sensing/measuring particular properties related to the patient. For example, the RPT device may comprise a pressure sensor that may be utilised by the system 5000 for detecting leaks that may impact therapy efficacy. Regarding the environmental sensors 5014, as set forth previously, these may be configured for sensing/measuring particular properties related to the patient's environment. For example, the mobile phone may comprise a camera that may be utilised by the system 5000 for detecting lighting in a bedroom.

[0308] When the computing device is the RPT device, a patient interface, e.g., a full-face mask, nasal mask, etc., used with the RPT device may also be configured with one or more sensors for collecting data relating to, and independent of, the patient's respiratory therapy. In this form, the patient interface may be coupled with the RPT device so as to communicate the measured properties from the patient interface to the RPT device, the collected data being used with the system 5000. This information may be used for management and ongoing 'personal assistance' for patients with sleeping disorders and to provide recommendations and/or automatic adjustments to therapy parameters as part of the feedback.

[0309] In this regard, the sensors of the RPT device may be arranged with respect to the patient to detect properties of the patient and also of the patient's surrounding environment. In some forms, the one or more sensors of the RPT device may be configured with respect to a positioning and stabilising structure of the patient interface. For example, the sensors 5012 may be arranged along the positioning and stabilising structure so as to contact (and detect properties of) the patient's skin.

[0310] The sensors 5012 configured on the positioning and stabilising structure of the patient interface may include one or more motion sensors, temperature sensors, light sensors, tactile sensors, altitude sensors, etc.

[0311] In some forms of the system 5000, the positioning and stabilising structure may also be configured with a photoplethysmography (PPG) sensor or an electroencephalography (EEG) sensor. The PPG and/or EEG sensor may be used for A2578192 12.0 52

20913400_1 (GHMatters) P120887.AU.1 measuring various electrical activities of the patient. A patient's endotype, e.g., sleep arousal threshold, may be estimated from respiratory signals derived from the PPG and/or EEG measurements.

[0312] The sensors 5012 may also be configured with respect to a mask or cushion of the patient interface. In this form, the sensors may be located within the mask of e.g., a full-face mask, and arranged so as to detect a patient's breath. Such sensors may be configured to detect specific gases. For example, nitrous oxide sensors may be used to detect increased levels of nitric oxide in the breath, which may be indicative of chronic obstructive pulmonary disease (COPD) or asthma. In another example, a carbon dioxide sensor may be used to detect increased levels of carbon dioxide in the patient's breath, which may be indicative of metabolic or respiratory alkalosis and acidosis.

[0313] The sensors 5012,5014 configured on the patient interface may be electrically connected with the RPT device. Electrical power and signals may be passed e.g., via wiring, between the sensors 5012,5014 and the RPT device. In some forms, the patient interface may be provided with an internal power source, i.e., separate to a power source of the RPT device, whereby the power source is configured to supply power to the sensors 5012,5014.

[0314] In other forms, the sensors 5012,5014 may be provided in the RPT device itself, i.e., so as to be remote from the patient interface. Such sensors may be configured to measure properties of the patient and their surrounding environment. For example, the RPT device may comprise motion sensors for detecting movement of the patient, e.g., during sleep. Alternatively or additionally, sensors may be provided in the RPT device for measuring temperature, humidity, etc., of the patient's bedroom.

[0315] Referring now to when the computing device is, or also uses, a mobile device 5002a such as a mobile phone or 'smart' watch, the mobile device 5002a may comprise sensors 5012,5014 being different to those provided in the RPT device 5002b. That is, the mobile device sensors 5002a may generate data about the patient which cannot be provided by sensors in the RPT device 5002b. These mobile device 5002a sensors may include accelerometers, gyroscopes, global positioning service

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(GPS), etc. Such sensors, as set forth in more detail below, are particularly suited to providing information on a mobility of the patient.

[0316] In the case of a sleeping patient, the collection of acceleration data and orientation data may allow the mobile device to indicate whether the patient is awake or asleep by detection of e.g., movement and body orientation. Conversely, when the patient is awake, acceleration data and orientation data may be useful to determine e.g., how 'active' the patient may be.

[0317] In some cases, when the mobile device is a mobile phone or 'smart' watch, it may comprise a GPS, i.e., a location service. In this case, a mobility of the mobile device may be measured to indicate large movements of the patient. That is, the mobile phone may be used to determine a location of the patient (i.e., of the mobile device) over time, so as to calculate e.g., a total distance travelled by the patient. In effect, this may indicate a total distance walked and/or run by the patient.

[0318] In some forms, a patient's heart rate may be monitored and measured by corresponding heart rate sensors, in addition or alternatively to monitoring their location over time (as set forth above). Monitoring and measuring the patient's heart rate may also be an effective indicator of their physical activity. Further to this, using the measure of heart rate together with location monitoring may provide a more accurate indication of the patient's physical state. For example, measuring a patient's heart rate in relation to physical activity, such as running a distance, may reflect how 'fit' the patient is.

[0319] The location data of the mobile device may also be analysed to determine whether the patient is walking or running, etc., based on the speed at which the mobile device is moving. As part of this, the system 5000 may be configured to determine that, if the patient cannot sustain a certain minimum speed for a minimum time, the patient may have an underlying sleep disorder. In this case, the underlying sleep disorder may be preventing the patient from exerting more effort. Alternatively or additionally, if the patient cannot sustain a certain minimum speed for a minimum time, it may be an indication of other underlying disorders, for example dyspnoea (i.e., breathlessness) that may occur in COPD patients.

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[0320] Alternatively, if the patient is not moving a minimum distance during a day, it may also be an indication that the patient has an underlying sleep disorder. In this case, the sleep disorder may be preventing the patient from going on walks, runs, etc. Additionally or alternatively, if the patient is not moving a minimum distance during a day, it may also be an indication of how effective the patient's existing respiratory therapy is, or indicate the patient's sleep habits may be negatively influencing the efficacy of their respiratory therapy.

[0321] In some forms, the sensors may include 'step counting' sensors for measuring e.g., how many steps the patient achieves in a period of time. Advantageously, counting steps may be a simpler method of measuring mobility of the patient compared to e.g., using location services. Further, the system 5000 may be configured to utilise step counting as a means of motivating the patient to move. For example, in addition to providing feedback to the patient on aspects of their sleep performance, the system may also present a 'goal' of e.g., 10,000 steps to motivate the patient to exercise more as a remedial action to improve their sleep performance.

[0322] Use of the mobile device to collect data relating to mobility, i.e., exercise of the patient, may be particularly advantageous when such data is collected over a period of time, e.g., weeks, months, etc. Such longitudinal data may be processed to indicate how 'active' a patient's lifestyle may be. For example, in the case of a patient who does not move much, i.e., having a sedentary lifestyle, it may indicate the patient may suffer from obesity.

[0323] Information relating to a patient's mobility may be utilised by the system 5000 to formulate advice to guide the patient's respiratory therapy. For example, in the case of patients having indications of obesity, the system 5000 may be configured to alert the patient of such risk and the influence it may have on their respiratory therapy. In the case where the system 5000 is used with an RPT device (i.e., the patient receiving PAP therapy), indications of e.g., obesity may be utilised by the system 5000 to provide a tailored management (i.e., 'personal assistance') of the patient's use of the RPT device to improve their sleep health.

[0324] Other types of sensors 5012,5014 may be utilised with the computing device in the form of either the mobile device or the RPT device. For example, a

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20913400_1 (GHMatters) P120887.AU.1 mobile phone or RPT device may comprise a microphone configured for sensing sound in its vicinity, such as breathing, snoring, etc. In this case, the microphone may listen for sounds, e.g., when the patient is in bed, to thereby determine whether the patient is awake or asleep.

[0325] The microphone may also be utilised to detect movement of the patient. In this case, the microphone may be configured together with a speaker to act as a sonar sensor. In this form, the speaker may produce sound at intervals, and the microphone may be used to listen for echoes of the sound when the speaker is not producing sound. In this way, the microphone and the speaker may detect movement of the patient.

[0326] Similarly, and as set forth previously, the mobile device and/or RPT device may also comprise a motion sensor for detecting movement of the patient.

[0327] The motion sensor and/or microphone/speaker may be located proximal to the patient, e.g., in a mobile device or RPT device located next to the patient's bed, or remote to the patient, i.e., as an environmental sensor 5014 located in e.g., a thermostat. In either form, movement data associated with the patient may be collected and processed to determine movement of the patient during sleep. This movement may be used as an indication of whether the patient is awake or asleep, and thereby be utilised by the system 5000 to feedback information to the patient about e.g. how effectively they sleep, how interruptions in sleep may relate to their respiratory therapy, etc.

[0328] In some forms, the motion sensor may be a radar sensor utilizing radio waves. In this form, the radar sensor may map where the patient is sleeping so as to track, e.g., frequency and period of movement of the patient during sleep, orientation of the patient's body, etc. Information relating to these measurements may be used by the system 5000 to determine e.g., whether the patient is experiencing a disturbed sleep, whether their body positions correlate to ineffective sleep, etc. The frequency of movement may also be recorded by the system 5000, whereby frequent movement may indicate a pattern of disturbed sleep that may indicate an underlying sleep disorder, interruptions in respiratory therapy (e.g., leaking air from the patient interface).

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[0329] In addition to the use of sensors 5012 to collect and analyse data relating to the patient, the system 5000 may also be configured collect and analyse usage data of a patient's mobile phone as an indication of sleep health that may impact the efficacy of a patient's respiratory therapy. For example, the system 5000 may be configured to record a frequency and duration of mobile phone use. Such data may be collected and analysed to provide an indication of whether the patient has an undiagnosed sleeping disorder such as insomnia (i.e., excessive use of the mobile phone may be a result of insomnia).

[0330] In some forms, the patient's frequency and duration of mobile phone use during 'sleeping hours' may also be an indication of poor sleep hygiene. In this case, the system 5000 may be configured to monitor and record usage data relating to: when the screen of the mobile phone is 'ON'; a level of battery drain correlated with sleeping periods; when the mobile phone is receiving touch inputs and/or voice commands; ambient sounds, etc. Information collected from these use-cases may indicate that the patient is using the mobile phone when they should otherwise be sleeping or attempting to sleep, and in effect, negatively impacting their respiratory therapy. As a result, i.e., an output of the system 5000 may be to advise the patient to cease or limit phone use during 'sleeping hours' in order to improve the patient's sleep health and in turn, efficacy of their respiratory therapy.

[0331] Based on the collection of data as set forth above, i.e., from mobile phone usage data, and also from data collected by sensors on either the RPT device or mobile device, the system 5000 may be configured to approximate a pattern of sleep behaviours. As set forth previously, the system 5000 may be configured to measure and collect multiple data sets over a period of time, e.g., days, weeks, months, etc. Data collected over such periods of time may be utilised to e.g., determine the patterns of sleep behaviour, such as whether the patient goes to sleep around the same time of day on most days. Other sleeping patterns may be approximated by e.g., periods and intervals of sleep, duration of sleep, sleep start and end times, etc.

[0332] The system 5000 may be configured to mark, i.e., 'timestamp' particular behaviours/ events of the patient and determine whether those behaviours affect, i.e., negatively impact, the patient's respiratory therapy. For example, the system 5000 may detect when a patient operates their mobile phone, watches television, has their A2578192 12.0 57

20913400_1 (GHMatters) P120887.AU.1 bedroom lights on, etc., during normal sleeping hours. In another example, sensors 5012 provided in the patient interface, may be configured to identify particular times when the patient interface is not sealing against a patient's face. Further, the sensors 5012 may be configured to detect the patient's sleeping position, orientation, etc., at the particular time when the patient interface was detected as not sealing against the patient's face.

[0333] These events, i.e., mobile phone usage, leakage in a patient interface, etc., may constitute brief interruptions in a patient's periods of sleep i.e., where the patient is waking multiple times during a sleep session, and may be measured and recorded by the system 5000. Such interruptions that impact the patient's normal sleeping efficacy, duration, etc., may be processed by the system 5000 and provided to the patient as feedback relating to how they may improve the efficacy of their respiratory therapy.

[0334] For example, the system 5000 may be configured to communicate to a patient whether the efficacy of their respiratory therapy has been affected by poor sleep hygiene. As set forth above, if the patient enters their bed and spends time engaged in other activities (e.g., mobile phone use) before sleep, the system 5000 may detect such behaviour, and alert the patient that their sleep may be affected, i.e., hindered, as a result of such behaviours. The system 5000 may also provide 'coaching' to the patient, advising/ recommending ways they could change their sleep habits to improve the efficacy of their respiratory therapy.

[0335] The system 5000 may also be configured to provide the patient with a view of their long-term sleep performance as a result of their respiratory therapy. As set forth previously, the system 5000 may be configured to formulate the view of long-term sleep performance by collecting, i.e., aggregating, data relating to a patient's sleep behaviour over a period of, e.g., weeks, months, etc. In this way, a patient may track changes, e.g., improvements in their sleep hygiene correlated with their respiratory therapy, e.g., compliance to therapy, frequency of OSA events, etc.

[0336] The system 5000 may also be configured communicate positive feedback to the patient in order to support their positive sleep hygiene. For example, if a patient is having a regular sleep period (i.e., without interruptions by e.g., mobile phone use),

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20913400_1 (GHMatters) P120887.AU.1 the system 5000 may indicate that the patient has good sleep hygiene and hence, their respiratory therapy is having maximal effect.

[0337] In cases where a patient's sleep performance is detected as being 'improved', the system 5000 may also be configured to demonstrate to the patient how and why such improvements to their sleep performance occurred. That is, the system 5000 may correlate changes in the patient's physiology with changes in their sleep performance. This may allow the system 5000 to advise the patient as to specifically which aspects of e.g., their sleep hygiene have impacted (positively, or negatively) their sleep performance.

[0338] For example, if a patient inputs their alcohol consumption (and timing) into the system 5000, then the system 5000 determines the patient's alcohol consumption is negatively impacting their sleep performance, the system may recommend that the patient lower (or change the timing of) their alcohol consumption. Then, if the system 5000 detects that the patient's sleep performance has improved as a result of the patient's changed alcohol related habits, the system may feedback this specific information to the patient. Advantageously, providing this specific feedback to the patient may motivate the patient to continue their habits related to alcohol consumption, i.e., knowing that such behaviour can result in a positive outcome.

[0339] In further forms, the system may be configured to monitor whether changes in the patient's sleep hygiene (being a result of the feedback provided by the system 5000) are positively affecting the patient's sleep performance. In a case where the positive feedback from the system 5000 does not result in positive changes to the patient's sleep performance, the system 5000 may be configured to recommend the patient consider respiratory therapy, e.g., PAP therapy. That is, an absence of improvement in sleep performance may be a result of factors beyond control by changes to a patient's sleep hygiene.

[0340] The system 5000 may be used to improve the patient's sleep hygiene prior to the patient being recommended to use respiratory therapy. Advantageously, the system therefore 'trains' the patient to develop optimal sleep hygiene such that when they commence respiratory therapy, the respiratory therapy has optimal effect on the

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20913400_1 (GHMatters) P120887.AU.1 patients sleep performance. That is, the patient's sleep habits are such that there is minimal influence (resulting from poor sleep hygiene) on the delivery of respiratory therapy.

[0341] In some forms, the system 5000 may also be configured to provide the patient with an indication of how 'awake' or 'recharged' they may feel as a result of the efficacy of their respiratory therapy. In this case, such feedback may be driven by data that indicates e.g., no leaks were detected in the patient interface during sleep, the patient's bed-time patterns were regular, mobile phone usage was outside the patient's normal bed-time, etc.

[0342] In addition to the use of data collected from the sensors and mobile device usage as set forth above, the system 5000 may also be configured to analyse personal data of the patient. For example, the system 5000 may be configured to utilise information voluntarily input by the patient, such as age, gender, smoking habits, diet (types of food intake, timing of eating, etc), etc. In the case of food intake and timing of eating, items such as alcohol and caffeine may both negatively impact a patient's ability to sleep, hence, monitoring their intake and timing can be important in effectively monitoring and providing accurate feedback to improve the patient's sleep performance. This 'manually input' information may be analysed together with the sensor data and mobile device usage data to provide more detailed advice to the patient regarding their respiratory therapy. Further, the 'manually input' information/data may be utilised together with 'automatically' collected information, i.e., from sensor data (collected as set forth previously) to drive feedback relating to how 'awake' or 'recharged' the patient may feel.

[0343] The manual input of patient information as set forth above may provide a more detailed 'risk profile' of a patient's likelihood of having or developing a sleep disorder e.g., insomnia. Information such as age and smoking habits may be taken into consideration by the system 5000 when analysing data collected about a patient's sleeping habits. Advantageously, this may allow the system 5000 to adjust feedback to the patient about their respiratory therapy performance in view of their 'risk profile'.

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[0344] The information generated about the patients' sleep health and respiratory therapy (as set forth above) may be communicated via the user interface 5008 in various formats. In some forms, the information may be communicated via written text or audio read aloud to the patient. In other forms, details of the patients' sleep health may be represented as illustrations, as set forth in more detail below.

[0345] In some forms, the patient's sleep health may be represented as a 'battery' illustration. In this form, the battery illustration may comprise an image of a battery, whereby the battery may be 'filled' e.g., with a colour, as a representation of how 'recharged' the patient may feel. This illustration may be similar to those used on mobile devices to indicate how 'full' a battery charge may be.

[0346] The representation of how 'recharged' a patient may be, could be determined by the one or more inputs as set forth previously. For example, sensor measurements, mobile phone usage, self-reported (i.e., manually input) information, etc, may be utilised to determine how 'recharged' the patient should feel. The amount of 'recharge' indicated on the representative battery may inform the patient about the efficacy of: their respiratory therapy, their sleep performance, sleep behaviours, habits, etc. Advantageously, this representation may indicate to the patient how they have improved their wellbeing, reflecting the patients' achievements relating to their sleep health.

[0347] Accordingly, in a least one form of the technology, a feedback system 5000 is provided that provides a user or patient with SBD a "holistic" view of their sleep characteristics encompassing aspects of sleep hygiene, sleep performance, sleep disorders, and/or performance under respiratory therapy. Relationships and associations may be made by the system across the data to enable targeted feedback to the user/patient to assist in diagnosis, improve efficacy of therapy, improve adherence and reinforcement of positive steps being taken. The system can more readily identify what is "working" and suggest targeted action steps to improve sleep health., The processor 5004 can apply any suitable signal processing routines (that are typically stored in memory 5006) to the data to identify the one or more sleep characteristics. For example, a signal processing routine may involve comparing a specific sleep characteristic signal to a stored signal, e.g. decomposing the respiration signal into characteristic frequencies associated with sleep-related respiratory disorders. The A2578192 12.0 61

20913400_1 (GHMatters) P120887.AU.1 combination of the various sleep characteristics measured and any self-reported data to provide a feedback response may be performed by a machine learning model.

4.6 OTHER REMARKS

[0348] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in Patent Office patent files or records, but otherwise reserves all copyright rights whatsoever.

[0349] Unless the context clearly dictates otherwise and where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limit of that range, and any other stated or intervening value in that stated range is encompassed within the technology. The upper and lower limits of these intervening ranges, which may be independently included in the intervening ranges, are also encompassed within the technology, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the technology.

[0350] Furthermore, where a value or values are stated herein as being implemented as part of the technology, it is understood that such values may be approximated, unless otherwise stated, and such values may be utilized to any suitable significant digit to the extent that a practical technical implementation may permit or require it.

[0351] Furthermore, "approximately", "substantially", "about", or any similar term used herein means +/- 5-10% of the recited value.

[0352] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present technology, a limited number of the exemplary methods and materials are described herein.

[0353] When a particular material is identified as being used to construct a component, obvious alternative materials with similar properties may be used as a

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20913400_1 (GHMatters) P120887.AU.1 substitute. Furthermore, unless specified to the contrary, any and all components herein described are understood to be capable of being manufactured and, as such, may be manufactured together or separately.

[0354] It must be noted that as used herein and in the appended claims, the singular forms "a", "an", and "the" include their plural equivalents, unless the context clearly dictates otherwise.

[0355] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and/or materials which are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present technology is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed.

[0356] The terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.

[0357] The subject headings used in the detailed description are included only for the ease of reference of the reader and should not be used to limit the subject matter found throughout the disclosure or the claims. The subject headings should not be used in construing the scope of the claims or the claim limitations.

[0358] Although the technology herein has been described with reference to particular examples, it is to be understood that these examples are merely illustrative of the principles and applications of the technology. In some instances, the terminology and symbols may imply specific details that are not required to practice the technology. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to indicate any order but may be utilised to distinguish between distinct elements. Furthermore, although process steps in the methodologies may be described or illustrated in an order, such an ordering is not required. Those skilled in the art will recognize that such ordering may be modified and/or aspects thereof may be conducted concurrently or even synchronously.

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[0359] It is therefore to be understood that numerous modifications may be made to the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the technology.

4.7 REFERENCE SIGNS LIST patient 1000 bed partner 1100 patient interface 3000 seal - forming structure 2100 cushion module 2150 plenum chamber 2200 chord 2210 superior point 2220 inferior point 2230 plenum chamber inlet port 2254 positioning and stabilising structure 2300 headgear 2302 four-point headgear 2302-1 two-point headgear 2302-2 strap 2310 inlet 2332 tube 2350 vent 2400 groove 2416 connection port 2600 elbow 2610 forehead support 2700 RPT device 3000 external housing 3010 upper portion 3012 portion 3014 panel 3015 chassis 3016 handle 3018 pneumatic block 3020 air filter 3110 inlet air filter 3112 outlet air filter 3114 muffler 3120 inlet muffler 3122 outlet muffler 3124 pressure generator 3140 blower 3142 A2578192 12.0 64

20913400_1 (GHMatters) P120887.AU.1 motor 3144 anti - spill back valve 3160 air circuit 3170 air circuit 3171 supplementary gas 3180 electrical components 3200 single Printed Circuit Board Assembly PCBA 3202 power supply 3210 input device 3220 central controller 3230 clock 3232 therapy device controller 3240 protection circuits 3250 memory 3260 transducer 3270 pressure sensor 3272 flow rate sensor 3274 motor speed transducer 3276 data communication interface 3280 remote external communication network 3282 local external communication network 3284 remote external device 3286 localexternaldevice 3288 output device 3290 display driver 3292 display 3294 humidifier 4000 humidifier inlet 4002 humidifier outlet 4004 humidifier base 4006 reservoir 4110 conductive portion 4120 humidifier reservoir dock 4130 locking lever 4135 water level indicator 4150 heating element 4240 system/personal assistant for improving sleep health 5000 computing device 5002 mobile device 5002a respiratory pressure therapy (RPT) device 5002b computing system 5004 memory 5006 user interface 5008 user control/input 5010

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20913400_1 (GHMatters) P120887.AU.1 sensor(s) 5012 environmental sensor(s) 5014

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Claims

1. A feedback system for assisting one or more sleep condition of a patient, the feedback system comprising:

one or more sensors configured to generate sensor data associated with the patient;

a memory storing machine-readable instructions; and

a computing system including one or more processors configured to execute the machine-readable instructions to implement a patient feedback process, by:

receiving patient data relating to at least two of the following conditions of the patient:

i) sleep hygiene;

ii) sleep performance;

iii) risk of having an undiagnosed sleeping disorder, and

iv) respiratory therapy

processing the patient data to determine a correlation between the at least two of: i), ii), iii) and iv); and

generating a feedback response responsive to the determined correlation.

2. A feedback system according to claim 1, wherein the determined correlation includes a correlation between:

i) sleep hygiene and sleep performance; ii) sleep hygiene and risk of having an undiagnosed sleeping disorder; or iii) sleep performance and risk of having an undiagnosed sleeping disorder.

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3. A feedback system according to claim 1 or 2, wherein the determined correlation includes a correlation to, or including, respiratory therapy.

4. A feedback system according to claims 1 to 3, wherein the received patient data includes data associated with a plurality of factors contributing to the patient condition, and the feedback process further comprises;

identifying one or more of the factors in the determined correlation, and

including the identified one or more factors in the generated feedback response.

5. A feedback system according to any preceding claim, wherein the patient data includes the sensor data and/or self-reported data.

6. A feedback system according to any preceding claim, wherein the computing system includes a mobile device.

7. A feedback system according to any preceding claim, wherein at least some of the sensor data is derived from a wearable device on the patient.

8. A feedback system according to any preceding claim, wherein the sensor data includes one or more physiological characteristics of the patient.

9. A feedback system according to claim 8, wherein at least some of the sensor data is derived from at least one of electroencephalography (EEG), electrocardiography (ECG), electrooculograpy (EOG), and electromyography (EMG) signals of the patient.

10. A feedback system according to any preceding claim, wherein the sensor data is environmental data derived from at least one sensor.

11. A feedback system according to claim 10, wherein the environmental data is derived from at least one of a motion sensor, temperature sensor, humidity sensor, light sensor, sonar sensor, tactile sensor, altitude sensor, gas sensor, accelerometer, gyroscope, GPS, or any combination thereof.

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12. A feedback system according to any preceding claim, wherein the feedback response is delivered through an output device configured to provide an acoustic, visual, or video output, or combination thereof.

13. A feedback system according to any preceding claim, wherein the feedback response is configured to provide positive reinforcement to the patient.

14. A feedback system according to any preceding claim, wherein the feedback response is configured to provide information to assist the patient improving their sleep hygiene and/ or sleep performance and/or respiratory therapy.

15. A feedback system according to any preceding claim, wherein the patient is undergoing respiratory therapy and the feedback response is configured to effect change to the respiratory therapy of the patient.

16. A feedback system according to any preceding claim, wherein the feedback response is configured to effect change to an external computing device.

17. A system for delivery of pressurised air or breathable gas to a patient, the system comprising:

a flow generator configured to generate a flow of air;

a patient interface constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, the patient interface being configured to deliver the pressurised air or breathable gas to the patient's airways for respiratory therapy; and

an air delivery tube coupled between the flow generator and the patient interface to deliver the flow of air from the flow generator to the patient interface as the pressurised air or breathable gas;

one or more first sensors configured to generate sensor data associated with the patient under respiratory therapy, and

a feedback system comprising

a memory storing machine-readable instructions; and

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20913400_1 (GHMatters) P120887.AU.1 a computing system including one or more processors configured to execute the machine-readable instructions to implement a patient feedback process to assist the patient under respiratory therapy, by: receiving sensor data from the one or more sensors generated under respiratory therapy; receiving patient related data independent of the respiratory therapy; processing the sensor data and the independent patient related data to determine one or more sleep characteristics of the patient; and generating a feedback response to the determined one or more sleep characteristic.

18. A system according to claim 17, wherein the one or more sleep characteristic is selected from the group comprising:

i) sleep hygiene;

ii) sleep performance; and

iii) risk of having an undiagnosed sleeping disorder.

19. A system according to claims 17 or 18, wherein the computing system includes a mobile device.

20. A system according to any one of claims 17 to 19, wherein the patient related independent data includes patient data derived whilst the patient is undergoing respiratory therapy.

21. A system according to any one of claims 17 to 120, wherein the patient related independent data includes patient data derived whilst the patient is not undergoing respiratory therapy.

22. A system according to any one of claims 17 to 21, wherein at least some of the patient related independent data is derived from a wearable device on the patient.

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23. A system according to any one of claims 17 to 22, wherein the independent patient related data can be the sensor data and/or self-reported data.

24. A system according to any one of claims 17 to 23, wherein the patient related independent data includes one or more physiological characteristics of the patient.

25. A system according to claim 24, wherein at least some of the patient related independent data is derived from sensors measuring at least one of electroencephalography (EEG), electrocardiography (ECG), electrooculograpy (EOG), and electromyography (EMG) signals of the patient.

26. A system according to any one of claims 17 to 25, wherein the patient related independent data is environmental data.

27. A system according to claim 26, wherein the environmental data is derived from at least one of a motion sensor, temperature sensor, humidity sensor, light sensor, sonar sensor, tactile sensor, altitude sensor, gas sensor, accelerometer, gyroscope, GPS, or any combination thereof.

28. A system according to any one of claims 17 to 27, wherein the patient feedback process is otherwise as claimed in claims 1 to 4.

29. A system according to any one of claims 17 to 28, wherein the feedback response is delivered through an output device configured to provide an acoustic, visual, or video output, or combination thereof.

30. A system according to any one of claims 17 to 29, wherein the feedback response is an indication of the one or more sleep characteristics.

31. A system according to any one of claims 17 to 30, wherein the feedback response is an indication of the efficacy of the respiratory therapy.

32. A system according to any one of claims 17 to 31, wherein the feedback response is configured to provide positive reinforcement to the patient under respiratory therapy.

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33. A system according to any one of claims 17 to 32, wherein the feedback response is configured to provide information to assist in improving efficacy of the respiratory therapy and/or the one or more sleep characteristics identified.

34. A system according to any one of claims 17 to 33, wherein the feedback response is configured to effect change to the flow generator for adjusting the delivery of pressurised air or breathable gas to a patient.

35. A system according to any one of claims 17 to 34, wherein the feedback response is configured to effect change to an external computing device.

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