ES2608815B1 - Outpatient device for monitoring circadian rhythms, sleep, environments and movement patterns. - Google Patents

Abstract

Ambulatory device for monitoring circadian rhythms, sleep, environments and movement patterns. # Registration device, ambulatory or home, comprising at least one activity sensor, an ambient humidity sensor, an atmospheric pressure sensor, at least two luxometers , one or two sound level meters, at least one event marker, at least one activity sensor, a body moisture sensor, at least one temperature sensor, a skin conductance sensor and a heart rate sensor, all collected in a base station and a probe that allows monitoring and analyzing the exposure to the main synchronizing signals (light, ambient temperature, social contacts) and other environmental factors. # The device can also detect chronodisruptor environments and monitors the rhythms of the subject ambulatoryly or while bedridden, such as sleep-wake rhythm, movement, respiratory rate, snoring, body temperature, or body position, and presence / absence of the subject in bed.

Description

5

10

fifteen

twenty

25

30

35

40

Four. Five

fifty

DESCRIPTION

Outpatient device for monitoring circadian rhythms, sleep, environments and movement patterns.

Field of the Invention

The present invention is included within the devices of measurement, recording, monitoring, analysis, transmission of information and diagnosis of altered states in relation to circadian rhythms and sleep along with the environmental conditions in which the life of the subject develops , with special attention to hospital environments and ergonomics of the workplace.

This device takes on special relevance when the person is in bed, being able to monitor the activity, temperature and respiratory sound of the subject together with the environment of the room and the microclimate of the bed without contact with the subject.

Background of the invention

The monitoring of physiological variables in general and medical in particular, is usually done by interfering with the subject's daily life and without taking into account the time of day. However, the so-called vital constants are actually variable with a daily rhythm that are modified according to the time of day.

Among the possible physiological variables to study, the dream and the variables related to it, monopolize a great interest in the medical, economic and welfare problems caused by its alterations.

There are also systems for detecting environmental and physiological variables in relation to sleep, such as the utility model ES1077771U and the patent ES2054992 that involve connecting the subject with cables or using a mobile device that makes movement difficult during sleep. The same goes for polygraphs and polysomnographs, in which the number of sensors and cables can be very annoying. On the other hand, there are systems for detecting portable or outpatient physiological variables, such as patents ES2364648 and ES2266760, which allow sleep monitoring throughout the day and the device must carry the device, however, these devices do not record environmental variables.

In addition there are special situations in which it is not convenient to directly monitor the subject as in the Intensive Care Units (ICUs), and that do not present solutions in this regard, since the sensorized mattresses only measure body temperature or pressure, such as ES1134957U device, in order to detect the presence of the subject, and the sensor bed US2005143617 makes it difficult to register more than one subject with the same device given the difficulty of its transfer.

Description of the invention

In order to facilitate the registration and monitoring of altered states in relation to circadian rhythms and avoid the inconveniences mentioned in the previous sections, the invention represents an advance in the matter by proposing a portable device that allows covering the existing wattage between different types of systems for

5

10

fifteen

twenty

25

30

35

40

Four. Five

fifty

monitor the subjects, without contact with them, which is capable of measuring both environmental variables and physiological variables of the subject itself.

The invention relates to a home or outpatient monitoring and recording system of physiological and medical variables composed of two distinct elements: a base station and a probe.

The base station is composed of a series of sensors that make it possible to typify the environment in which the subject is located, and evaluate the possible thermal and acoustic contamination, as well as if the temperature and humidity are outside the comfort ranges. Specifically, this station is made up of one or two ambient temperature sensors, an ambient humidity sensor, and an atmospheric pressure sensor (which allows recording the environmental conditions of the nearby environment), at least two lux meters for different wavelengths (blue , green, red, infrared and total spectrum) to monitor light intensity and light exposure schedule, one or two sound meters to measure the noise produced by the subject and / or ambient noise, at least one event marker ( to indicate meal times, medication, work, etc., and request the device for its current status, such as the battery level) and optionally a GPS to determine the geographical position. It also incorporates an internal microprocessor for data processing, a battery, an internal memory for the storage of pre-processed or raw data and the necessary elements for the wire and / or wireless transmission of the same (either by NFC, Bluetooth, WIFI, LIFI, USB or microUSB port) to an external device, as well as a series of LEDs indicating the battery level, if the device is connected by USB, if there is an active mission or if an event has been marked.

For its part, the probe, which allows measuring different physiological variables of the subject, is formed by a triaxial acrometer or activity sensor, to evaluate both the intensity of the activity and the duration and frequency of the movements and the resting time, a sensor of humidity, a temperature sensor, a skin conductance sensor, and a heart rate sensor. It also incorporates the necessary elements for the transmission of data through cable connection, and / or wireless connection (NFC, Bluetooth, WIFI, LIFI) either to the base station or to an external device.

The combined processing of the signals recorded by the sensors of both the base station and the probe, or of both elements, allows obtaining a set of variables related to the sleep-wake rhythm such as bed time, sleep latency, beginning and end of the dream, the night awakenings, in addition to the moment in which they occur. It also allows you to calculate the depth of sleep, detect periodic movements of legs, myoclonus, snoring and apnea, as well as the presence or not of the subject in bed. All this accompanied by the simultaneous information of the environmental conditions, especially those related to the type of lighting and the intensity to which the subject is exposed.

The heart rate and activity sensors allow you to monitor the subject's activity and intensity, which together with the presence of a GPS that allows you to determine where the individual is, makes it possible to know and compare with the local atmospheric data.

The processed information can be displayed on a computer or mobile phone or by other means, and informs and could advise the subject about the possible corrections to be introduced

5

10

fifteen

twenty

25

30

35

40

Four. Five

fifty

in the environment to improve your sleep hygiene and the synchronization of your circadian system, but it can also provide information that facilitates the diagnosis of obstructive sleep apnea and other sleep disorders, as well as altered movement patterns, the speed of the march or to modify postural habits.

This device is preferably used in the environment where the subject sleeps using the probe to record the subject's own variables (heart rate, activity, body position, skin conductance, temperature and humidity) and the base station for environmental variables, ( temperature and humidity, atmospheric pressure, light intensity, and type of light: total spectrum, blue, green, red and infrared, ambient noise produced by the subject, localization and marking of events), and can also be used on an outpatient basis with the probe attached to the subject (arm, leg, chest, abdomen or neck, for example) and the station attached to the belt or cover in a backpack or bag.

Brief description of the figures

FIG 1.- Schematic representation of the device prototype. The base station is shown in the left part of the figure, while the probe is shown in the right part of the figure. The prototype scheme shows the approximate position of the sensors that integrate the station and the probe in part A. In part B, the disposition of both units is shown in the case of wireless operation, while in part C they are shown both units connected by cable and the USB charger that will power your battery and allow its connection to a computer or other electronic device.

FIG 2.- Schematic representation of the possible components of the device, formed by two independent modules, or not, that sensorize the subject (Probe) and its environment (Station).

FIG 3.- Block diagram. The device has a microcontroller with clock, timer and calendar clock, which through a digital interface (GPIO) interacts with the rest of the elements shown in the figure.

FIG 4.- Device firmware. Once the device has been disconnected from the computer that manages it, it goes into SLEEP mode, unless an activity has been programmed, the user requests the status or connects again to the computer to charge it or to program it.

FIG 5.- Example of utilization of the station and fixed probe in the bed. The sensors are located according to 1. The data obtained and processed from the main sensors are available for viewing when the device is connected to a computer. In this case the values of temperature (2), light (3), activity measured as acceleration (4), movement time (5) and position (6) recorded during a full night of a subject are represented. The white area represents the waking period and the shaded area represents the sleep period. Arrows (7) indicate awakenings.

FIG 6.- Example of the use of the station and probe for detection of respiratory sound. 1: Sensor temperature in bed; 2: Visible light level (lux); 3: Position X axis of the sensor in the bed; 4: Average sound intensity in 30 s; 5: Level

5

10

fifteen

twenty

25

30

35

40

Four. Five

fifty

10Hz sound intensity; By means of the fixed position in the bed, the sound intensity level is recorded at 10 Hz (5), the intensity of the sound produced by the subject can be amplified, as shown in 6, to allow recording the respiratory rate and intensity of a benign snoring

FIG 7.- Example of the use of the fixed station in the bed and of the probe placed on the diaphragm of the subject. The combination of respiratory movements with snoring, allows to accurately detect episodes of obstructive sleep apnea. 1: Normal breathing; 2: Snoring; 3: Apnea; 4: Snoring: 5: Apnea; 6: Snoring. The upper line (7) indicates the sound level, the lower line (8) the subject's movement.

FIG 8.- Example of using the station and probe on an outpatient basis to detect tremor in the extremities. The station can be carried attached to the belt or in a bag or backpack, while the probe, connected wirelessly and placed on the back of the hand allows the detection of tremor at rest and the alteration of the temperature regulation (dysautonomia) of a Parkinson's disease patient. The upper line (1) indicates the acceleration of the X axis over time; The bottom line (2) indicates the Y axis acceleration over time.

FIG 9.- Example of the use of the station and ambulatory probe for the detection of postural habits. The placement of the probe in the back aligned with the spine allows the detection of the position of the subject while performing a sedentary activity such as working before a computer. The recording of the light intensity, ambient temperature and noise level allows simultaneous evaluation of the working conditions of the subject.

FIG 10.- Example of use of the station and ambulatory probe for the detection of speed of the march. To do this, just place the probe attached to a limb or trunk to determine the steps taken by the subject in a given time. The arrows (1) indicate each step, in this case three.

Reference List

1. Event markers.

2. Signal receiver.

3. GPS.

4. Luxometers.

5. Thermometer and hygrometer.

6. Barometer.

7. Sonometer.

8. Connectors.

9. Heart rate sensor.

5

10

fifteen

twenty

25

30

35

40

Four. Five

fifty

10. Sonometer.

11. Acrometer.

12. Thermometer and hygrometer.

13. Signal transmitter.

14. Connector.

15. Conductance of the skin.

16. USB cable connection computer and charging.

17. Interconnection cable.

Example of realization of the invention

As already indicated, and as can be seen in Figure 1, the device for monitoring environments and portable people, has been preferably designed to monitor the subject without contact, which makes the device especially suitable for hospital environments with bedridden patients or to monitor sleep at home. In addition, it is formed by two independent parts but intercommunicated with each other, probe and station, as can be seen in Figures 1 and 2, wired and / or wireless. The probe consists of sensors for, at least, temperature, humidity, sound, heart rate, skin conductance and activity together with a series of optional sensors such as grid or distance pressure sensors. On the other hand, the station consists of at least 2 luxometers, but preferably 5, to detect different spectra (red, green, blue, infrared and total spectrum), and a temperature, humidity, atmospheric pressure, GPS, sound, 3 sensor event markers and other series of optional sensors to measure, for example, wind speed, ultraviolet light or other variables (Figures 1 and 2).

The device is structured around a microcontroller (Figure 3), preferably located in the station, and has a clock, a clock-calendar and a timer, which through an interface manages the power and charge of the battery. This battery feeds to the sensors, both analog and digital, the signal processing circuit and voltage reference, which is part of the signal processing circuit. The sensors are connected to the microcontroller through a serial interface and an A / D (analog / digital converter) that in turn communicate with the microcontroller through the interface. The acquired data is preferably stored in the internal memory of the station. Finally, through the digital interface (GPIO), the status of the pushbuttons and event markers is checked, as well as the sending of control signals of the status of the indicator LEDs (on already paid) as shown in Figure 3.

Once the device has been disconnected from the computer that manages it, it goes into SLEEP mode. Unless an activity is scheduled, the user requests the status or reconnects to the computer to load it or to program it. The programmed functions are the collection of information from the sensors at a frequency between 8 and 32 Hz, the post-processing of said information at intervals

5

10

fifteen

twenty

25

30

35

40

Four. Five

fifty

Selectable and battery check every 10 minutes. In addition, an event (long press) can be marked with the pushbuttons, which would be included as additional information to the collection by the sensors, while a short press requests the status of the device and the battery charge.

The device only starts up, and ceases to be in SLEEP mode in one of the following cases as indicated in Figure 4:

1. Reading data from the sensors: this procedure is only performed when the device has active registration with a programmed cadence (timer 1).

2. Information processing and storage: this procedure is performed at a frequency determined by timer 2 when the device has active registration.

3. Battery check: this procedure is carried out in accordance with the programming of timer 3 regardless of the registration status.

4. Activation of a button by the user: the device activates and informs the battery status, whether it has an active registration or not, or introduces an event in case it has an active registration (depending on the button or the duration of the pulsation).

5. Connection via cable: the device is activated to start charging the battery.

6. Programming: either by wireless connection or by cable, the device is activated to allow the download of information or to establish a new configuration.

Preferred modes of utilization include placing the probe on the mattress and the station on the headboard of the bed in order to detect the dream and its characteristics, without contacting the subject at any time. The downloaded information, allows to detect the periods of sleep of the subject and the associated awakenings, determined by the movement of the subject in the bed and / or marking of the event button, as well as the presence / absence of the subject in the bed (with values of temperature stabilized at 35 ° C when the individual is in bed), changes in position or turns in bed and the environmental constancy of the environment close to the subject's bed, as shown in Figure 5. It also allows to detect the noise associated with snoring. The information can be obtained with a high resolution, allowing to detect the sound specifically associated with the subject's breaths, as illustrated in Figure 6.

In case you want to make an evaluation of a possible obstructive sleep apnea. the probe is placed on the diaphragm, while the station remains in the headboard of the bed as illustrated in Figure 7. In this case, the combined information of the respiratory sound together with the movement of the diaphragm allows the apnea episodes to be detected, its duration and its frequency during the night.

As noted above, due to its characteristics, the device can be used only using the station, placing it in a fixed place, to monitor work, rest or hospital environments, or connected to the

5

10

fifteen

twenty

25

30

probe to record the characteristics of the dream and its possible pathologies. Additionally, thanks to its small size, the station can also be transported attached to the belt or hung in a bag, and receive the information of the probe placed in different parts of the body for the monitoring of physiological variables, such as temperature and skin conductance, motor activity, body position, etc.

Other modes of actuation in which the station is carried by the subject include the use of the station and the probe to detect on an outpatient basis the motor alterations of a patient with Parkinson's disease, as shown by way of example in Figure 8. In this case, the placement of the probe in the patient's hand allows not only to detect the person's tremor at rest, using the acceleration of two of the axes of the accelerometer programmed in high resolution, but also using the temperature channel of the skin and electrical conductance there is a fundamental information to detect the existence of vascular alterations (dysautonomies) due to the progression of their disease and / or the effectiveness of the possible treatment established. For this same functionality, the probe could also be placed in the arms, back or legs.

The device also presents a mode of use to record the ergonomic conditions of a workplace, where we can not only monitor the level of light, temperature, noise and ambient humidity, but also the position of the subject in his workplace, detecting errors posture them through the recording of the position of the spine, as illustrated in Figure 9.

Another of the possible ways of utilization of the device involves monitoring the speed of gait and the level of physical activity of the subject, in this case, the probe is placed in one of the extremities or at the waist, while the probe is worn hanging from the belt as shown in Figure 10.

The set of possible configurations, sensors used and preferred modes of use are summarized in the following table:

 Setting

 Sensors activated Station Probe Preferred operating modes

 1.- Station in fixed position

 Humidity Noise Pressure Light Position GPS Events -Monitoring hospital environments -Monitoring work environments -Monitoring of bedrooms

 2.- Station + probe in fixed position without contact with the subject

   Temperature Movements Body position Humidity -Monitoring sleep rhythm- in hospital environments (FIGURES 5 AND 6) -Monitoring sleep-wake rhythm in bedrooms (FIGURES 5 AND 6) • Monitoring of ergonomic conditions of the workplace

 3.- Fixed station + probe connected to the subject

 Temperature Humidity Noise Atmospheric pressure Light Position GPS Events Tempcritura pi »l Conductantia electrici skin Frequeneia cardiac * Subject movements Respiratory movements Body position -Monitoring rhythm of sleep-wake {FIGURES 5 AND, 6 AND 7) -Detection of obstructive sleep apnea ( FIGURE 7) - Detection of sleep disorders due to periodic leg movements

 4.- Ambulatory station + probe connected to the subject

 Temperature Humidity Noise Atmospheric pressure Light GPS Position Events Skin temperature Conductance electrics skin Heart rate Subject movements Respiratory movements Body position -Detection of altered movement patterns (Parkinson's disease, Hurgtinton ...) (FIGURE 8) -Monitoring postural habits ( FIGURE 9) -Speed speed (FIGURE 10)

Claims (11)

5 10 fifteen twenty 25 30 35 40 Four. Five fifty 1. Device for home and ambulatory monitoring and recording of circadian rhythms, sleep, environments and movement patterns, comprising a base station and a probe, characterized in that the base station is formed by: - one or two ambient temperature sensors, - an ambient humidity sensor, - an atmospheric pressure sensor, - at least two lux meters for different wavelengths (blue, green, red, infrared and total spectrum), - one or two sensors for noise monitoring, both environmental and produced by the subject. - at least one event marker, and because the probe is composed of: - at least one activity sensor, - a humidity sensor, - at least one temperature sensor, - a skin conductance sensor, - a heart rate sensor. 2. Device for home and ambulatory monitoring and recording of rhythms circadians, sleep, environments and movement patterns according to claim 1, characterized in that the base station comprises a GPS to determine the geographical position of the subject. 3. Device for monitoring and home or ambulatory recording of rhythms circadians, sleep, environments and movement patterns according to claims above, characterized in that the base station and the probe meet intercommunicated with each other in a wired or wireless way. 4. Procedure for monitoring circadian rhythms, sleep-wake, environments and movement patterns according to the device of claims 1, 2 and 3, which operates as follows: a) The base station is placed in a fixed place in the work, rest or hospital space that is intended to be monitored without direct contact with the subject, while the probe is placed in the proximity of the subject whose activity is to be measured, but without contact Direct with it. 5 10 fifteen twenty 25 30 35 40 Four. Five b) The sensors of activity, heart rate, temperature, ambient humidity, skin conductance and noise produced by the subject, together with the event markers, monitor the physiological variables of the subject, while the sensors of light intensity, atmospheric pressure , ambient noise, temperature and humidity, together with GPS, typify the environment in which the subject is located, and evaluate the possible thermal and acoustic contamination, as well as if the temperature and humidity are outside the comfort ranges. c) The values of all these variables are stored in the internal memory of the station or transmitted to an external device, either by Wi-Fi, Bluetooth or other form of wired or wireless connection. These variables can be preprocessed or not by the internal microprocessor before transmission. d) The state of circadian rhythms, sleep, environments and movement patterns is evaluated based on changes in the values resulting from the previous stages. 5. Procedure according to claim 4 characterized in that the probe is placed in direct contact with the subject. 6. Procedure according to claim 4 characterized in that the base station can be transported by the subject in a portable manner. 7. Method according to claims 4, 5 and 6 in which the probe is placed on the diaphragm of the subject, in order to detect episodes of obstructive sleep apnea, its duration and frequency during the night, by recording the environmental noise variables or produced by the subject, as well as by the temperature and conductance of the skin, heart rate and movements (activity) and body position of the subject. 8. Method according to claims 4, 5 and 6 in which the probe is placed in the hands, arms, back or legs of the subject, to detect altered movement patterns, such as those caused by Parkinson's or Hungtinton's disease, as well as the subject's postural habits and the speed of gait, by recording the variables of temperature and conductance of the skin, heart rate and movements (activity) and body position of the subject. 9. Method according to claims 4, 5 and 6 in which the base station and the probe are placed in a fixed place in the space to be monitored, without direct contact with the subject, to evaluate the ergonomic conditions of the workstation by means of the record of the variables of temperature, light, ambient noise, ambient humidity and body position. 10. Use of the device according to claims 1-9 for mattress sensorization. 11. Use of the device according to claims 1-9 for evaluation of the light pollution.