WO2025250438A1 - Phototherapy system and method - Google Patents

Abstract

Aspects of the present invention relate to a phototherapy system, comprising at least one radiative source configured to produce electromagnetic radiation (EMR) in one or more spectral bands, one or more sensors, and a controller that performs operations comprising calculating a point of gaze, calculating a distance between the subject and the at least one radiative source, setting a brightness to a brightness threshold when the calculated gaze of the subject is directed toward the at least one radiative source and the calculated distance is within an operational range, calculating an exposure time of the subject based on the calculated point of gaze and the brightness, and setting the brightness to a second brightness threshold when the exposure time exceeds a treatment duration, wherein the brightness of the at least one radiative source has a radiated power above a power threshold within a circadian wavelength range.

Description

TITLE

PHOTOTHERAPY SYSTEM AND METHOD

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No. 63/653,399 filed on May 30, 2024, incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

Electrical lighting fails to deliver “daylight” signals to the human body, which evolved to exhibit biological rhythms that repeat themselves approximately every 24 hours due to the earth’s rotation. Optimal cell and tissue function require 30+ minute exposure to bright, morning light (460 nm - 480 nm) to set the body’s clock genes, inducing up to 50% of all genes to display 24-hour cycling. This means that in the era of indoor living, subjects are suffering en masse from daytime circadian light deficiency, a modifiable risk factor for diseases like depression and insomnia.

Phototherapy or light exposure is a unique and highly controllable treatment method for physiological systems. Phototherapy has been previously used to treat depression, pain, inflammation, psychiatric disorders, dementia, cancer, as well as bone marrow transplant patients. Unfortunately, in many cases, patients are confined to a hospital bed or indoors. The amount of light received by the patient is in many cases uncontrolled and unrecorded. Additionally, many clinical trials provide phototherapy in a combined treatment, however the clinical trials typically do not provide guidelines for the type or duration of light exposure.

Circadian Stimulus (CS) is a score for determining the level of circadianrelevant light a subject is exposed to. It has been discovered that a circadian stimulus (CS) of at least 0.3 elicits a response in a subject for providing normative or corrective light stimulus for circadian rhythm as shown in Rea et al., 2022 [Rea, Mark S., et al. "The circadian stimulus-oscillator model: Improvements to Kronauer’s model of the human circadian pacemaker." Frontiers in Neuroscience 16 (2022): 965525], Additionally, currently a phototherapy comprising a CS score of at least 0.3 cannot be prescribed by a physician.

Thus, there is the need in the art for a system and method for providing controllable circadian-relevant phototherapy to a subject for in some examples treating circadian light deficiency. The present invention meets this need.

SUMMARY OF THE INVENTION

Aspects of the present invention relate to a phototherapy system, comprising at least one radiative source configured to produce electromagnetic radiation (EMR) in one or more spectral bands, one or more sensors, and a controller communicatively connected to the at least one radiative source and the one or more sensors, the controller comprising a processor and memory storing instructions that when executed by the processor causes the processor to perform operations comprising calculating a point of gaze of the subject based on data received from the one or more sensors, calculating a distance between the subject and the at least one radiative source based on data received from the one or more sensors, setting a brightness of the at least one radiative source to a brightness threshold when the calculated gaze of the subject is directed toward the at least one radiative source and the calculated distance is within an operational range of the at least one radiative source, calculating an exposure time of the subject based on the calculated point of gaze and the brightness, and setting the brightness of the at least one radiative source to a second brightness threshold when the exposure time exceeds a treatment duration, wherein the brightness of the at least one radiative source has a radiated power above a power threshold within a circadian wavelength range.

In some embodiments, the circadian wavelength range comprises wavelengths within the 420 nm - 680 nm range. In some embodiments, the circadian wavelength range comprises wavelengths within the 460 nm - 480 nm range. In some embodiments, the operational range of the at least one radiative source ranges between 1 inch and 48 inches. In some embodiments, power to the at least one radiative source is provided for at least one duration of time, wherein the duration of time ranges between 1 min and 45 min. In some embodiments, the at least one radiative source produces EMR comprising an illuminance ranging between 200 lux and 400 lux, and a Correlated Color (CCT) ranging between 6900 K and 7100 K. In some embodiments, the illuminance is 358.6 lux, and the CCT is 7035.5 K. In some embodiments, the at least one radiative source produces EMR with a Circadian Stimulus (CS) of at least 0.3. In some embodiments, the at least one radiative source comprises a light source, a display or a screen, and the one or more sensors comprises a camera, a distance sensor and a light sensor.

In some embodiments, the system further comprises a wearable device that at least partially houses at least one of the at least one radiative source, the one or more sensors, and the controller. In some embodiments, the wearable device comprises an AR/VR headset.

Aspects of the present invention relate to phototherapy method, comprising the steps of providing at least one radiative source configured to produce electromagnetic radiation (EMR) in one or more spectral bands, and one or more sensors with a controller communicatively connected to the at least one radiative source and the one or more sensors, the controller comprising a processor and memory storing instructions that when executed by the processor causes the processor to perform operations comprising calculating a point of gaze of the subject based on data received from the one or more sensors, calculating a distance between the subject and the at least one radiative source based on data received from the one or more sensors, setting a brightness of the at least one radiative source to a brightness threshold when the calculated gaze of the subject is directed toward the at least one radiative source and the calculated distance is within an operational range of the at least one radiative source, calculating an exposure time of the subject based on the calculated point of gaze and the brightness, and setting the brightness of the at least one radiative source to a second brightness threshold when the exposure time exceeds a treatment duration, wherein the brightness of the at least one radiative source has a radiated power above a power threshold within a circadian wavelength range. In some embodiments, the method further comprises the step of calculating a Circadian Stimulus (CS) scoring for the subject. In some embodiments, the circadian wavelength range comprises wavelengths within the 460 nm - 480 nm range.

In some embodiments, the operational range of the at least one radiative source ranges between 1 inch and 48 inches. In some embodiments, the exposure time of the subject ranges between 1 min and 60 min.

In some embodiments, the treatment duration is programmed on a schedule or with an algorithm. In some embodiments, the at least one radiative source comprises a light source, display or screen and the one or more sensors comprises a camera, a distance sensor, and a light sensor.

In some embodiments, the method further comprises the step of measuring ambient EMR the subject is exposed to, and ceasing power to the at least one radiative source when ambient EMR is detected in one or more spectral bands above a predetermined threshold. In some embodiments, the one or more spectral bands comprise EMR between the range of 420 nm and 680 nm.

BRIEF DESCRIPTION OF THE DRAWINGS

The following detailed description of embodiments of the invention will be better understood when read in conjunction with the appended drawings. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities of the embodiments shown in the drawings.

FIG. 1 is an image depicting an exemplary phototherapy system according to aspects of the present invention.

FIG. 2A is a diagram depicting an exemplary user interface (UI) for a phototherapy system according to aspects of the present invention.

FIG. 2B is a diagram depicting an exemplary architecture for a computer for practicing the various embodiments of the invention.

FIG. 3 is a diagram depicting an exemplary phototherapy method according to aspects of the present invention.

FIG. 4 depicts an experimental setup for testing a phototherapy system. FIG. 5 is a plot showing results for Irradiance (W/m²/nm) vs CCT (K) at various distances from the light source in the experimental setup of FIG. 4

FIGs. 6A - 6F are images depicting an exemplary UI for a phototherapy system according to aspects of the present invention. FIG. 6A is an image depicting a start screen for the UI. FIG. 6B is an image depicting a login screen. FIG. 6C is an image depicting a sign up screen. FIG. 6D is an image depicting a sign up screen with entered information. FIG. 6E is an image depicting a disclaimer screen for the UI. FIG. 6F is an image depicting a signable disclaimer screen.

FIGs. 7A - 7B are images depicting an exemplary onboarding process within a UI for a phototherapy system according to aspects of the present invention. FIG. 7A is an image depicting a subject health or home screen for the UI. FIG. 7B is an image depicting a subject preparation screen.

FIGs. 8A - 8H are images depicting an exemplary survey within a UI for a phototherapy system according to aspects of the present invention. FIG. 8A is an image depicting a subject survey screen for the UI. FIG. 8B is an image depicting a demographics survey screen. FIG. 8C is an image depicting another demographics survey screen. FIG. 8D is an image depicting a sleep and circadian details screen. FIG. 8E is an image depicting another sleep and circadian details screen. FIG. 8F is an image depicting another sleep and circadian details screen. FIG. 8G is an image depicting another sleep and circadian details screen. FIG. 8H is an image depicting a light sensitivity screen.

FIGs. 9A - 9D are images depicting an exemplary calibration process within a UI for a phototherapy system according to aspects of the present invention. FIG. 9A is an image depicting a calibration screen for the UI. FIG. 9B is an image depicting another calibration screen. FIG. 9C is an image depicting another calibration screen. FIG. 9D is an image depicting a calibration success screen.

FIGs. 10A - 10E are images depicting an exemplary content selector within a UI for a phototherapy system according to aspects of the present invention. FIG. 10A is an image depicting a content selector screen for the UI. FIG. 10B is an image depicting another content selector screen. FIG. IOC is an image depicting an exemplary content screen. FIGs. 11 A - 1 IB are images depicting exemplary analytics within a UI for a phototherapy system according to aspects of the present invention. FIG. 11 A is an image depicting an analytics screen for the UI. FIG. 1 IB is an image depicting a logout screen.

DETAILED DESCRIPTION

It is to be understood that the figures and descriptions of the present invention have been simplified to illustrate elements that are relevant for a clear understanding of the present invention, while eliminating, for the purpose of clarity many other elements found in related systems and methods. Those of ordinary skill in the art may recognize that other elements and/or steps are desirable and/or required in implementing the present invention. However, because such elements and steps are well known in the art, and because they do not facilitate a better understanding of the present invention, a discussion of such elements and steps is not provided herein. The disclosure herein is directed to all such variations and modifications to such elements and methods known to those skilled in the art.

Definitions

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 the invention pertains. Although any methods and materials similar or equivalent to those described herein can be used in the practice for testing of the present invention, exemplary materials and methods are described herein. In describing and claiming the present invention, the following terminology will be used.

It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

The articles “a” and “an” are used herein to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article. By way of example, “an element” means one element or more than one element. “About” as used herein when referring to a measurable value such as an amount, a temporal duration, and the like, is meant to encompass variations of ±20%, ±10%, ±5%, ±1%, or ±0.1% from the specified value, as such variations are appropriate.

The terms “patient,” “subject,” “individual,” “user”, and the like are used interchangeably herein, and refer to any animal amenable to the systems, devices, and methods described herein. The patient, subject or individual may be a mammal, and in some instances, a human.

Ranges: throughout this disclosure, various aspects of the invention can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 2.7, 3, 4, 5, 5.3, and 6. This applies regardless of the breadth of the range.

The present invention discloses various novel systems and methods for performing phototherapy on a subject. Although exemplary phototherapy systems are disclosed, it should be appreciated that the systems and methods disclosed herein may reside on, or operate on or in part with any phototherapy system or device having at least one radiative source capable of emitting circadian relevant or stimulating light (e.g., light having the wavelengths and intensities to induce a circadian rhythm in a subject), and having one or more sensors capable of subject and/or facial recognition while measuring the distance from the radiative source to the subject. Also disclosed herein is a novel software application with a user interface (UI) that operates various aspects of the disclosed systems and methods. In some embodiments, the software application comprises a subject survey, calibration process, content reader, and various analytics. Further, disclosed herein is a phototherapy method comprising one or more algorithms for calculating various phototherapy treatment parameters, including, but not limited to, the time of day that a subject should receive phototherapy, or the duration of the phototherapy. In some embodiments, the phototherapy method further comprises calculating a bed time or wake time for a subject. In some embodiments, the method comprises providing feedback to the subject relating to educational content (e.g., information regarding circadian rhythm), treatment progress, sleep regularity, light exposure, and treatment adherence reporting.

In some embodiments, the disclosed phototherapy system and method is configured to at least partially reside on an iPad XDR Pro, or other XDR equipped Apple products, or any similar system or device capable of emitting circadian relevant or stimulating light. In some aspects, the disclosed phototherapy system and method targets clock genes via stimulation of intrinsically photosensitive retinal ganglion cells (ipRGCs) with circadian relevant or stimulating light.

Phototherapy System

Referring now to FIG. 1, shown is an exemplary phototherapy system 100 according to aspects of the present invention. Generally, system 100 comprises at least one radiative source 110, and one or more sensors 120 configured to track at least a portion of a subject and measure the distance 150 between the subject and the at least one radiative source 110 and/or the one or more sensors 120. In some embodiments, the one or more sensors 120 are configured to track the face of the subject, or the track the point of gaze of the subject. In some embodiments, the one or more sensors 120 measure at least one distance 150 to the subject. In some embodiments, the distance 150 is the dimensions between the at least one radiative source 110 and the subject, or the subject’s face, or eyes. In some embodiments, the at least one radiative source 110 comprises a display or screen (e.g., and LCD display).

In some embodiments, the at least one radiative source 110 is configured to produce circadian relevant light or circadian stimulating light. In some embodiments, at least one radiative source 110 is configured to produce light having a Circadian Stimulus (CS) score ranging between 0.1 and 0.6, between 0.1 and 0.5, between 0.2 and 0.5, or between 0.3 and 0.4. In some embodiments, the at least one radiative source 110 produces light with a CS of > 0.3. In some embodiments, the at least one radiative source 110 produces light having a CS of about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, or 1.0. In some embodiments, the at least one radiative source 1 10 produces light or electromagnetic radiation (EMR) in one or more wavelengths at one or more intensities. In some embodiments, the at least one radiative source 110 produces light or EMR in one or more spectral bands at one or more intensities. In some embodiments, at least one radiative source 110 produces photochromatic light and/or narrowband light.

It should be appreciated herein that the at least one radiative source must produce radiation or light in an acceptable range from a subject (e.g., human) use standpoint. That is, the light or radiation cannot be so bright or powerful that the subject cannot stand to look at the light source. In fact, aspects of this invention relate to directing the eyes or gaze of the subject directly at the light source in order to provide a quantifiable treatment and elicit a reproducible circadian response. Further, wavelengths, spectral distributions, color fidelity, and intensity may be modified or altered based upon the exact radiative source chosen, or as a result of the capabilities of the radiative source (e.g., the specific tablet, bulb, light source, etc.). Overall, the ability of the chosen radiative source may dictate any of the spectrum, intensity and duration of phototherapy treatment produced for the subject.

In some embodiments, the at least one radiative source 110 is configured to produce light or EMR in one or more spectral bands at one or more intensities, densities (e.g., photon densities), or irradiances. For example, in some embodiments, the at least one spectral band comprises wavelengths within the 420 nm - 680 nm range produced at any acceptable intensity, density or irradiance. In some embodiments, the at least one spectral band comprises wavelengths within the 460 nm - 480 nm range. In some embodiments, the at least one spectral band comprises at least a first target wavelength, wherein the target wavelength is 462 nm. In some embodiments, the at least one radiative source 110 is configured to produce one or more spectral distributions, wherein the spectral distribution comprises one or more specific wavelengths, each at a specific intensity. Examples of spectral distributions known to elicit a circadian response (i.e., circadian relevant or stimulating light) from a subject can be found in Rea et al., 2022 [Rea, Mark S., et al. "The circadian stimulus-oscillator model: Improvements to Kronauer’s model of the human circadian pacemaker." Frontiers in Neuroscience 16 (2022): 965525], For example, a radiative source producing circadian relevant light may be described as producing a spectral distribution comprising at least a first wavelength region at a first intensity, a second wavelength region at a second intensity, and a third wavelength region at a third intensity. In some embodiments, a narrow band light source produces a first set of wavelengths at one or more intensities, and a polychromatic light source produces a second set of wavelengths at one or more intensities. In some embodiments, the at least one radiative source 110 is configured to produce an overall flux density on the retina of a subject, wherein the overall flux density on the retina ranges between 1 and 1000 scotopic lx, or between 100 and 500 scotopic lx, or between 200 and 400 scotopic lx, or at about 300 scotopic lx.

In some embodiments, the at least one radiative source 110 produces light or EMR comprising an illuminance ranging between 200 lux and 400 lux, and a Correlated Color (CCT) ranging between 6900 K and 7100 K. In some embodiments, in the illuminance is 358.6 lux, and the CCT is 7035.5 K.

In some embodiments, the operational range of the at least one radiative source 110 ranges between 1 inch and 96 inches, between 1 and 48 inches, between 1 and 36 inches, between 1 and 24 inches, or between 16 and 18 inches. In some embodiments, the operational range is about 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, or 24 inches. In some embodiments, the operational range is dependent on the radiative source’s ability to produce a CS of > 0.3. In some embodiments, the operational range is static, or dynamic based on external factors such as the radiative source’s ability to produce a CS, subject-related factors (e.g., eye size, distance to subject), or environmental factors (ambient light), or any combinations thereof.

In some embodiments, the at least one radiative source 110 comprises any of: a light source, narrowband light source, polychromatic light source, screen, display, headset, VR headset, AR headset, VR/AR headset, glasses, specialized glasses, specialized contact lenses, TVs, phones, tablets, lamps, light bulbs, vanity mirrors, windows, the sun, and any combinations thereof. In some embodiments, the one or more sensors 120 comprises any of: a camera, a stereoscopic camera, a facial recognition sensor, a facial feature recognition sensor, a Face ID sensor, a phone or tablet sensor package, LiDAR Scanner, wearables, headset, VR/AR headset, smart watch, smart glasses, Oura, Fitbit, Apple Watch, Rabbitt Al gadget, Blue Iris light sensor, IMU, three- axis gyro, accelerometer, ambient light sensor, infrared sensor, distance sensor, light sensor, proximity sensor, transducer, ultrasonic sensor and/or transducer, or any combinations thereof. In some embodiments, the at least one radiative source 110 and the one or more sensors 120 comprises an emitter/ sensor combination such as an VR/AR headset, specialized glasses, smart glasses, tablets, iPad, iPad XDR, or the like. In some embodiments, system 100 is configured to operate on an iPad XDR Pro tablet, or similarly equipped Apple XDR devices, and displays customized content in XDR format (w/ white background).

In some embodiments, system 100 may be described as either a closed loop, or open loop system. For example, in an exemplary closed loop system, system 100 measures facial distance, uses facial feature recognition and/or tracking (i.e., eye tracking, facial feature sizing), detects the presence of the subject’s face, detects the gaze of the subject, and calibrates and/or applies the phototherapy based on the measured and/or detected features. In some embodiments, system 100 measures the size of the face of the subject, or the size of the eyes of the subject. In some embodiments, the closed loop system comprises a questionnaire answered by the subject. An exemplary open loop system comprises instructions received from a practitioner for the phototherapy, or bedtime and wake time set by a practitioner or a subject, or operations based upon time zone, sunset, sunrise, or the like.

In some embodiments, system 100 modulates the EMR or light wavelength, spectrum, intensity, duration, or frequency based on the radiative source size (e.g., screen size), distance of radiative source to face (e.g., distance 150), face size, gaze, gaze orientation (i.e., eye position tracking), eye size, presence or absence of glasses, presence or absence of filter on the radiative source 110 or screen, presence of ambient light, ambient light spectrum and intensity, and any combinations thereof. In some embodiments, system 100 operates a treatment algorithm comprising a CS Score model, or CS Score algorithm, wherein a subject’s light exposure is incorporated into the algorithm or model to calculate the precise phototherapy needed for the subject. In some embodiments, light exposure of the subject is monitored with one or more sensors described herein (e.g., one or more sensors 120), wherein the sensors detect light exposure for the subject over a day and night in order to calculate the required phototherapy for the following day. In some embodiments, the exposure of the subject is measured using the subject’s phone, tablet, or other devices. In some embodiments, if the subject does not receive a phototherapy on a certain day, or is not exposed to enough ambient light to illicit the necessary circadian response, the algorithm will compensate for this missed or inadequate phototherapy the following day. In some embodiments, system 100 addresses subjects with certain needs or desires (e.g., tired in the afternoon, elderly, mild cognitive impairment, change to sleep schedule, travel).

In some embodiments, system 100 is personalized to the individual. In some embodiments, system 100 calibrates or modulates the phototherapy to the size of the subject’s head, face, or eyes, or gender, race, ethnicity, height, weight, condition, disease, location, or any combinations thereof. In some embodiments, system 100 calculates the subject’s exposure to light or provides a chronotype for the subject (owl or lark).

In some embodiments, system 100 produces circadian relevant light at an appropriate interval to target genes that are regulated or affected by circadian light therapy. In some embodiments, the genes are selected from: Atp4a, Serpina6, Pgr, Nr3c2, Adrb2, Pla2g4a Fcgr2b, Ms4al, Fcgr3 Slc22a6, Agtrla, Slcolb2, Car4, Kcnma, Adralb Neu2, Neul, Ceslg, Slc22a8, Slcl5al, Slc6a4 Slc22a4, Slc22a3, Ar, Cyplal, Cyp2bl0, Slc22a5, Cyp2bl0, Egfr, Abcbla Htr2c, Htrlb, Htr2a, Chrm2, Drd4, Adr, Cyplal, Pde6g, Abcc5, AbcclO, Pde5a, Slco2bl, Slc22a5, Qprt, Slcl6al Igflr Tyms, Atic, Gart, Slc29al Slc22a5, Slc22a4, Chrm2, Adrbl, Adrb2 Adrbl, Adrb2 Slc47al, Slc22a2, Prkabl, Abcbla, Dpp4 Slc22a2, Adrbl, Adrb2, Abcbla Hmgcr, Cyp2bl0, Soatl, Abcc2, Anpep, Cyplal, Atp4a, Abcg2 Ptgsl, Tspo, Gabra3 Cyplal, Atp4a, Abcg2, Cyplbl, Abcbla Slc6a4. In some embodiments, system 100 targets clock genes that transmit signals to cells in the body of the subject. In some embodiments, the target genes are selected from: NR1D2, NR1D1, LGAL23, CRY1, CRISPLD2, ELMO2, PER2, KLF9, FKBP4, PER3, PERI, HSPH1. Further exemplary known target genes may be found in Wittenbrink et al., 2018 [Wittenbrink, Nicole, et al. "High-accuracy determination of internal circadian time from a single blood sample." The Journal of clinical investigation 128.9 (2018): 3826-3839], In some embodiments, system 100 comprises a controller (e.g., computer 200 described herein) communicative and/or electronically connected to the at least one radiative source 110 and one or more sensors 120. In some embodiments, the controller comprises a processor and memory storing instructions thereon that when executed by the processor causes the processor to perform one or more operations. In some embodiments, the operations comprise tracking the point of gaze of the subject and measuring the distance (e.g., distance 150) between the subject and the at least one radiative source 110. In some embodiments, the operations comprise providing power to the at least one radiative source 110 when the gaze of the subject is directed towards the at least one radiative source 110 and/or when the measured distance is within an operational range of the at least one radiative source 110. In some embodiments, the operations comprise turning off power to the at least one radiative source 110 when the gaze of the subject is directed away from the at least one radiative source 110, and/or when the measured distance is outside an operational range of the at least one radiative source 110.

In some embodiments, power to the at least one radiative source 110 is provided for at least one duration of time, wherein the duration of time ranges between 1 min and 45 min. In some embodiments, the at least one duration of time is 1 min, 2 min, 3 min, 4 min, 5 min, 6 min, 7 min, 8 min, 9 min, 10 min, 11 min, 12 min, 13 min, 14 min, 15 min, 16 min, 17 min, 18 min, 19 min, 20 min, 21 min, 22 min, 23 min, 24 min, 25 min, 26 min, 27 min, 28 min, 29 min, 30 min, 31 min, 32 min, 33 min, 34 min, 35 min,

36 min, 37 min, 38 min, 39 min, 40 min, 41 min, 42 min, 43 min, 44 min, 45 min, 46 min, 47 min, 48 min, 49 min, 50 min, or any duration of time in between. In some embodiments, the duration of time is at least 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, or 30 minutes. In some embodiments the duration of time is about 30 minutes. In some embodiments, the duration of time is dependent on the CS produced by at least one radiative source 110 on the subject. In some embodiments, the duration of time is less when the CS is higher (>0.3), and/or the duration of time is more when the CS is lower (<0.3). Exemplary phototherapy treatments and time durations may be found in Rea et al., 2021 and Nagare et al., 2019 [Rea, Mark S., Rohan Nagare, and Mariana G. Figueiro. "Modeling circadian phototransduction: Quantitative predictions of psychophysical data." Frontiers in neuroscience 15 (2021): 615322; Nagare, Rohan, et al. "Nocturnal melatonin suppression by adolescents and adults for different levels, spectra, and durations of light exposure." Journal of biological rhythms 34.2 (2019): 178-194] Additionally, the power to the at least one radiative source 110 may be provided intermittently, or in patterns, programs, or frequencies. In some embodiments, power is provided to at least a portion of the at least one radiative source 110, for example, but without limitation, providing power to a portion or all of the pixels of a screen or display. In some embodiments, power to the at least one radiative source 110 is provided at least a first power level and a second power level, wherein each power level may range from 0% to 100%. In some embodiments, the first power level is a higher power level, and the second power level is a lower power level, or vice versa. In some embodiments, the power level gradually increases or decreases from the first power level to the second power level, and then back down to the first power level. In some embodiments, the power level is based on the distance 150 to the subject. In some embodiments, the power to the at least one radiative source 110 may be provided dynamically with a programmable waveform, as may be found in US Patent 11,006,488 B2, the contents of which are incorporated by reference in their entirety.

Aspects of the present invention relate to a software application for phototherapy comprising a user interface (UI) or graphical user interface (GUI) in some examples referred to interchangeably herein as “RESET” or “Circadian OS”. Generally, the interfaces described for system 100 are used to configure, calibrate and use the system, and can execute steps of any disclosed phototherapy method. The interface is configured to produce circadian light therapy with at least one radiative source, which in some embodiments may by the screen of the device, or another radiative source. The interface may provide an overview of the subject's health (e.g., circadian health), subject preparation, surveys, as well as analytics.

Referring now to FIG. 2A, shown is a diagram of an exemplary GUI comprising one or more screens or dashboards. Depicted is an exemplary screen or dashboard 200 for the GUI comprising a navigation bar 210 and content area 220. In some embodiments, navigation bar 210 comprises links for profile set up, treatments, content and/or analytics. In some embodiments, dashboard 200 provides one or more tabs and/or lists with organized lists, widgets, modules, alerts, graphs, and/or reports displayed in the content area 220 that provide schedules, sensor data, plots, subject-related data and other metrics and results. In some embodiments, dashboard 200 further comprises a search tool 230 and drop down menu or selector 240. In some embodiments, dashboard 200 provides means for configuring and viewing one or more profiles related to a subject. In some embodiments, content area 220 displays treatment information, data and analytics for a profile related to each subject, and any other content disclosed herein.

In some embodiments, the UI is produced by a software that runs on existing devices (e.g., iPads). In some embodiments, the disclosed software utilizes an extended dynamic range (XDR) capability of a display device, for example the iPad Pro’s XDR capabilities, to boost screen brightness and/or contrast in order to deliver therapeutic doses of light. In some embodiments, using the disclosed software, subjects can read news articles, email, or send messages while in the background the screen emits circadian effective light. In some embodiments, the disclosed software utilizes the iPad’s sensors to create a closed-loop system to 1) detect the user’s distance from the screen 2) detect the user’s gaze, 3) monitor the user’s light exposure and 4) deliver therapeutic doses of light (e.g., CS > 0.3).

In some embodiments, the software can detect whether the user is close enough to the screen to get sufficient light exposure and whether they were looking at the screen for long enough, and automatically extends the treatment time accordingly to ensure sufficient dosing. FIG. 1 depicts a hospitalized patient receiving circadian light therapy via a GUI (e.g., Circadian OS) from a phototherapy system according to aspects of the present invention. Table 2 disclosed herein describes an exemplary phototherapy algorithm comprising subject prompts and steps employed by the software.

Exemplary UI screens and content is discussed below in Example 1, and shown in FIGs. 6-11. FIGs. 6A - 6F depict an exemplary User Interface (UI) for a phototherapy system according to aspects of the present invention.

FIGs. 7A - 7B depict an exemplary onboarding process within a UI for a phototherapy system. In embodiments, the home screen or section "Your circadian health" shows the calculated schedule for wake, light therapy and sleep, as well as the user’s "Circadian Score" and "Goal cards", advising users on how to improve their circadian health. FIGs. 8A - 8H are images depicting an exemplary survey within a UI for a phototherapy system. FIG. 8A shows a UI screen prompting a user to fill out a questionnaire designed to determine their chronotype, sleep need, level of circadian disruption and calculate daily timing of light therapy.

FIGs. 9A - 9D are images depicting an exemplary calibration process within a UI for a phototherapy system. An exemplary calibration process may comprise an explanation of the calibration process for the user/patient/subject. In some embodiments, the calibration uses the camera of the device to detect the user/patienf s face and eyes, so that during light therapy sessions the user/pati ent's gaze is continuously monitored. This is used to dynamically calculate the circadian stimulus and lengthen the duration of the light therapy if the user doesn't look at the screen or is further than 17 inches away. In some embodiments, the user/patient may also receive live notifications to return to the session if they have been absent for a period of time (e.g., >= 5 min) during a session, or holding the device a distance from the subject (e.g., >17 inches) for a period of time (e.g., >= 5 min).

FIGs. 10A - 10E are images depicting an exemplary content selector within a UI for a phototherapy system according to aspects of the present invention. In some embodiments, the user/patient selects categories of articles they will be reading during their light therapy session.

FIGs. 11 A - 1 IB are images depicting exemplary analytics within a UI for a phototherapy system according to aspects of the present invention. In some embodiments, exemplary analytics may comprise showing usage, progress on light therapy, and compliance with the sleep schedule

Computing Device

In some aspects of the present invention, software executing the instructions provided herein may be stored on a non-transitory computer-readable medium, wherein the software performs some or all of the steps of the present invention when executed on a processor.

Aspects of the invention relate to algorithms executed in computer software. Though certain embodiments may be described as written in particular programming languages, or executed on particular operating systems or computing platforms, it is understood that the system and method of the present invention is not limited to any particular computing language, platform, or combination thereof. Software executing the algorithms described herein may be written in any programming language known in the art, compiled, or interpreted, including but not limited to C, C++, C#, Objective-C, Java, JavaScript, MATLAB, Python, PHP, Perl, Ruby, or Visual Basic. It is further understood that elements of the present invention may be executed on any acceptable computing platform, including but not limited to a server, a cloud instance, a workstation, a thin client, a mobile device, an embedded microcontroller, a television, or any other suitable computing device known in the art.

Parts of this invention are described as software running on a computing device. Though software described herein may be disclosed as operating on one particular computing device (e.g. a dedicated server or a workstation), it is understood in the art that software is intrinsically portable and that most software running on a dedicated server may also be run, for the purposes of the present invention, on any of a wide range of devices including desktop or mobile devices, laptops, tablets, smartphones, watches, wearable electronics or other wireless digital/cellular phones, televisions, cloud instances, embedded microcontrollers, thin client devices, or any other suitable computing device known in the art.

Similarly, parts of this invention are described as communicating over a variety of wireless or wired computer networks. For the purposes of this invention, the words “network”, “networked”, and “networking” are understood to encompass wired Ethernet, fiber optic connections, wireless connections including any of the various 802.11 standards, cellular WAN infrastructures such as 3G, 4G/LTE, or 5G networks, Bluetooth®, Bluetooth® Low Energy (BLE) or Zigbee® communication links, or any other method by which one electronic device is capable of communicating with another. In some embodiments, elements of the networked portion of the invention may be implemented over a Virtual Private Network (VPN).

FIG. 2B and the following discussion are intended to provide a brief, general description of a suitable computing environment in which the invention may be implemented. While the invention is described above in the general context of program modules that execute in conjunction with an application program that runs on an operating system on a computer, those skilled in the art will recognize that the invention may also be implemented in combination with other program modules.

Generally, program modules include routines, programs, components, data structures, and other types of structures that perform particular tasks or implement particular abstract data types. Moreover, those skilled in the art will appreciate that the invention may be practiced with other computer system configurations, including handheld devices, multiprocessor systems, microprocessor-based or programmable consumer electronics, minicomputers, mainframe computers, and the like. The invention may also be practiced in distributed computing environments where tasks are performed by remote processing devices that are linked through a communications network. In a distributed computing environment, program modules may be located in both local and remote memory storage devices.

FIG. 2B depicts an illustrative computer architecture for a computer 300 for practicing the various embodiments of the invention. The computer architecture shown in FIG. 2B illustrates a conventional personal computer, including a central processing unit 350 (“CPU”), a system memory 305, including a random access memory 310 (“RAM”) and a read-only memory (“ROM”) 315, and a system bus 335 that couples the system memory 305 to the CPU 350. A basic input/output system containing the basic routines that help to transfer information between elements within the computer, such as during startup, is stored in the ROM 315. The computer 300 further includes a storage device 320 for storing an operating system 325, application/program 330, and data.

The storage device 320 is connected to the CPU 350 through a storage controller (not shown) connected to the bus 335. The storage device 320 and its associated computer-readable media provide non-volatile storage for the computer 300. Although the description of computer-readable media contained herein refers to a storage device, such as a hard disk or CD-ROM drive, it should be appreciated by those skilled in the art that computer-readable media can be any available media that can be accessed by the computer 300. By way of example, and not to be limiting, computer-readable media may comprise computer storage media. Computer storage media includes volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storage of information such as computer-readable instructions, data structures, program modules or other data. Computer storage media includes, but is not limited to, RAM, ROM, EPROM, EEPROM, flash memory or other solid state memory technology, CD-ROM, DVD, or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information and which can be accessed by the computer.

According to various embodiments of the invention, the computer 300 may operate in a networked environment using logical connections to remote computers through a network 340, such as TCP/IP network such as the Internet or an intranet. The computer 300 may connect to the network 340 through a network interface unit 345 connected to the bus 335. It should be appreciated that the network interface unit 345 may also be utilized to connect to other types of networks and remote computer systems.

The computer 300 may also include an input/output controller 355 for receiving and processing input from a number of input/output devices 360, including a keyboard, a mouse, a touchscreen, a camera, a microphone, a controller, a joystick, or other type of input device. Similarly, the input/output controller 355 may provide output to a display screen (e g., a UI or GUI), a printer, a speaker, or other type of output device. The computer 300 can connect to the input/output device 360 via a wired connection including, but not limited to, fiber optic, Ethernet, or copper wire or wireless means including, but not limited to, Wi-Fi, Bluetooth, Near-Field Communication (NFC), infrared, or other suitable wired or wireless connections.

As mentioned briefly above, a number of program modules and data files may be stored in the storage device 320 and/or RAM 310 of the computer 300, including an operating system 325 suitable for controlling the operation of a networked computer. The storage device 320 and RAM 310 may also store one or more applications/programs 330. In particular, the storage device 320 and RAM 310 may store an application/program 330 for providing a variety of functionalities to a user. For instance, the application/program 330 may comprise many types of programs such as a word processing application, a spreadsheet application, a desktop publishing application, a database application, a gaming application, internet browsing application, electronic mail application, messaging application, and the like. According to an embodiment of the present invention, the application/program 330 comprises a multiple functionality software application for providing word processing functionality, slide presentation functionality, spreadsheet functionality, database functionality and the like.

The computer 300 in some embodiments can include a variety of sensors 365 for monitoring the environment surrounding and the environment internal to the computer 300. These sensors 365 can include a Global Positioning System (GPS) sensor, a photosensitive sensor, a gyroscope, a magnetometer, thermometer, a proximity sensor, an accelerometer, a microphone, biometric sensor, barometer, humidity sensor, radiation sensor, or any other suitable sensor.

Phototherapy Method

Aspects of the present invention relate to various phototherapy methods using a phototherapy system (e.g., system 100 disclosed herein). Referring now to FIG. 3, shown is an exemplary phototherapy method 400. In some embodiments, method 400 comprises the steps of 401 providing a phototherapy system (e.g., system 100) comprising at least one radiative source configured to produce circadian relevant light, and one or more sensors, and a controller communicatively connected to the at least one radiative source and the one or more sensors, the controller comprising a processor and memory storing instructions that when executed by the processor causes the processor to perform operations comprising: 402 calculating a point of gaze of the subject based on data received from the one or more sensors; 403 calculating a distance between the subject and the at least one radiative source based on data received from the one or more sensors; 404 setting a brightness of the at least one radiative source to a brightness threshold when the calculated gaze of the subject is directed toward the at least one radiative source, and the calculated distance is within an operational range of the at least one radiative source; 405 calculating an exposure time of the subject based on the calculated point of gaze and the brightness; and 406 setting the brightness of the at least one radiative source to a second brightness threshold when the exposure time exceeds a treatment duration, wherein the brightness of the at least one radiative source has a radiated power above a power threshold within a circadian wavelength range.

In some embodiments, method 400 further comprises the step of measuring the light or EMR irradiance on the subject or the subject’s corneas in one or more spectral bands. In some embodiments, method 400 further comprises the step of ceasing or reducing power to the at least one radiative source when the EMR irradiance of the subject or the subject’s corneas reaches one or more thresholds. In some embodiments, method 400 further comprises the step of displaying text or images to the subject.

In some embodiments, the one or more thresholds comprises a CS threshold for the at least one radiative source, wherein the power threshold is based upon the at least one radiative source’s CS score.

In some embodiments, the operational range of the at least one radiative source ranges between 1 inch and 96 inches, between 1 and 48 inches, between 1 and 36 inches, between 1 and 24 inches, or between 16 and 18 inches. In some embodiments, the operational range is about 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, or 24 inches. In some embodiments, the operational range of the at least one radiative source is dependent on the source’s ability to produce a CS of > 0.3. In some embodiments, the operational range of the at least one radiative source 110 is static, or dynamic based on external factors such as the source’s ability to elicit a CS, subject-related factors, environmental factors, or the like.

In some embodiments, power to the at least one radiative source is provided for at least one duration of time, wherein the duration of time ranges between 1 min and 99 min. In some embodiments, the duration of time is at least 30 min. In some embodiments, the at least one duration of time is 1 min, 2 min, 3 min, 4 min, 5 min, 6 min, 7 min, 8 min, 9 min, 10 min, 11 min, 12 min, 13 min, 14 min, 15 min, 16 min, 17 min, 18 min, 19 min, 20 min, 21 min, 22 min, 23 min, 24 min, 25 min, 26 min, 27 min, 28 min, 29 min, 30 min, 31 min, 32 min, 33 min, 34 min, 35 min, 36 min, 37 min, 38 min, 39 min, 40 min, 41 min, 42 min, 43 min, 44 min, 45 min, 46 min, 47 min, 48 min, 49 min, 50 min, or any duration of time in between. In some embodiments, the duration of time is at least 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, or 30 minutes. In some embodiments the duration of time is about 30 minutes. In some embodiments, the duration of time is dependent on the CS of the at least one radiative source 110 on the subject. In some embodiments, the duration of time is less when the CS is higher (>0.3), and/or the duration of time is more when the CS is lower (<0.3). Exemplary time durations may be found in Rea et al., 2021 and Nagare et al., 2019 [Rea, Mark S., Rohan Nagare, and Mariana G. Figueiro. "Modeling circadian phototransduction: Quantitative predictions of psychophysical data." Frontiers in neuroscience 15 (2021): 615322; Nagare, Rohan, et al. "Nocturnal melatonin suppression by adolescents and adults for different levels, spectra, and durations of light exposure." Journal of biological rhythms 34.2 (2019): 178-194]

In some embodiments, the power to the at least one radiative source 110 is programmed on a schedule or with an algorithm. In some embodiments, the schedule comprises applying light to the subject (i.e., the phototherapy) in the morning or at sunrise, or applying the phototherapy every 24 hours.

In some embodiments, method 400 further comprises the steps of measuring ambient light or EMR, and ceasing, reducing, or increasing power to the at least one radiative source when ambient light or EMR is detected in one or more spectral bands. In some embodiments the one or more spectral bands comprise light or EMR with wavelengths ranging between 420 nm and 680 nm, or the spectral bands of early morning light.

In some embodiments, the method may optionally comprise the step of calculating a CS score for a subject. For example, the step of calculating a CS score may comprise portions or all of methods found in found in Kronauer et al. [Kronauer, R. E., Forger, D. B., and Jewett, M. E. (2000). Erratum to: Quantifying human circadian pacemaker response to brief, extended, and repeated light stimuli over the photopic range. J. Biol. Rhythms 15, 184-186. doi: 10.1177/074873099129001073] or Rhea et al. [Rea, Mark S., et al. "The circadian stimulus-oscillator model: Improvements to Kronauer’ s model of the human circadian pacemaker." Frontiers in Neuroscience 16 (2022): 965525], In some embodiments, the method comprises the step of performing a multimodal test that diagnoses a CS score. In some embodiments, the method comprises the step of treating the subject based on a score below a certain threshold. In some embodiments, the method comprises the step of re-measuring the CS score of the subject. In some embodiments, the method comprises the step of measuring a blood sample before, during, and/or after phototherapy treatment. In some embodiments, the method comprises the step of pausing or ending the treatment when an individual or subject looks away from the screen, and/or puts the tablet down, and may optionally comprise the step of resuming treatment when the subject returns, and/or looks at the screen or their gaze returns to the screen. In some embodiments, the system or method comprises the step of treating a patient for at least 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 30 days, 60 days, 90 days or any number of days. In some embodiments, the system or method provides a compensatory dose for a missed dose. In some embodiments, method 400 comprises the step of providing a compensatory dose for a missed dose.

In some embodiments, the disclosed phototherapy system or method may be used to treat neuro-psychiatric disorders including circadian disorders, insomnia, depression, pain, stroke neurodegenerative disorders including dementia, Parkinson’s mild cognitive impairment Alzheimer’s, multiple sclerosis, neoplasms including solid and blood cancers, auto-immune disorders, metabolic and cardiovascular disorders such as diabetes, obesity, hypertension, atherosclerosis. Also, the disclosed phototherapy system and method may service as a companion therapy to augment efficacy and reduce side effects of existing drugs and therapies, such as cancer chemo and immunotherapies. In some embodiments, the disclosed phototherapy method or system may be used to preadjust a subject to a different time zone before, during, or after travel.

EXPERIMENTAL EXAMPLES

The invention is further described in detail by reference to the following experimental examples. These examples are provided for purposes of illustration only, and are not intended to be limiting unless otherwise specified. Thus, the invention should in no way be construed as being limited to the following examples, but rather, should be construed to encompass any and all variations which become evident as a result of the teaching provided herein.

Without further description, it is believed that one of ordinary skill in the art can, using the preceding description and the following illustrative examples, make and utilize the present invention and practice the claimed methods. The following working examples therefore are not to be construed as limiting in any way the remainder of the disclosure.

Aspects of the present invention relate to a software application for phototherapy comprising a user interface (UI) in some examples referred to interchangeably as “RESET” or “Circadian OS”. In some embodiments, RESET is a software that runs on existing iPads. The disclosed software in some embodiments utilizes an extended dynamic range (XDR) capability of a display device, for example the iPad Pro’s XDR capabilities, to boost screen brightness and/or contrast in order to deliver therapeutic doses of light. In some embodiments, using the disclosed software, subjects can read news articles, email, or send messages while in the background the screen emits circadian effective light. In some embodiments, RESET utilizes the iPad’s sensors to create a closed-loop system to 1) detect the user’s distance from the screen 2) detect the user’s gaze, 3) monitor the user’s light exposure and 4) deliver therapeutic doses of light, Circadian Stimulus > 0.3 [Rea, Mark S., et al. "The circadian stimulus-oscillator model: Improvements to Kronauer’s model of the human circadian pacemaker." Frontiers in Neuroscience 16 (2022): 965525], In some embodiments, the software can detect whether the user is close enough to the screen to get sufficient light exposure and whether they were looking at the screen for long enough, and automatically extends the treatment time accordingly to ensure sufficient dosing. FIG. 1 depicts a hospitalized patient receiving circadian light therapy via Circadian OS from a phototherapy system according to aspects of the present invention.

In some embodiments, hardware requirements preferably include a tablet with screen technology able to elicit a Circadian Stimulus (CS) (a unit defined in Rea et al., 2019 [Rea, Mark S., and M. G. Figueiro. "Light as a circadian stimulus for architectural lighting." Lighting research & technology 50.4 (2018): 497-510]). CS measures a light source’s ability to set the body’s “clock genes” & associated circadian rhythms by calculating the spectrally weighted irradiance of light at the cornea. Preferably, the tablet should be able to produce a CS of > 0.3 at a distance from the eyes of 17 inches. In the disclosed example, the tablet was equipped with a functional camera and was able to display text and images on the screen. Discussed herein are the results of a disclosed phototherapy system including a characterization of a circadian light source using the novel Circadian OS, an iPad app. Shown in FIG. 4 is an exemplary measurement setup of a phototherapy system. FIG. 5 is a plot showing results for Irradiance (W/m2/nm) vs CCT (K) at various distances from the light source in the experimental setup of FIG. 4

Shown in Table 1 is irradiance at different distances from the eye of the subject (i.e., Measured illuminance, color corrected temperature and Circadian Stimulus at different distances from the eye).

Table 1: Distance from iPad vs Illuminance, CCT, and CS

Disclosed herein is an exemplary software application user interface and associated algorithms in some examples referred to as “RESET” or “Circadian OS” software. FIGs. 6A - 6F depict an exemplary User Interface (UI) for a phototherapy system according to aspects of the present invention. FIG. 6A is an image depicting a start screen for the UI. FIG. 6B is an image depicting a login screen. FIG. 6C is an image depicting a sign up screen. FIG. 6D is an image depicting a sign up screen with entered information. FIG. 6E is an image depicting a disclaimer screen for the UI. FIG. 6F is an image depicting a signable disclaimer screen.

FIGs. 7A - 7B depict an exemplary onboarding process within a UI for a software application on a phototherapy system according to aspects of the present invention. FIG. 7A shows an exemplary home screen for the application. The section "Your circadian health" shows the calculated schedule for wake, light therapy and sleep, as well as the user’s "Circadian Score" and "Goal cards", advising users on how to improve their circadian health. FIG. 7B is an image depicting a subject preparation screen. An exemplary closed-loop system comprising an algorithm for optical circadian stimulation of humans (e.g., Application Algorithm) is described. In some embodiments, an exemplary algorithm comprises an onboarding process comprising an explanation to the user/patient how the process works, via text and images, or possibly a short video.

FIGs. 8A - 8H depict an exemplary survey within a UI for a phototherapy software application according to aspects of the present invention. FIG. 8A shows a UI screen prompting a user to fdl out a questionnaire designed to determine their chronotype, sleep need, level of circadian disruption and calculate daily timing of light therapy. See Table 2 for the detailed algorithm. FIG. 8B is an image depicting a demographics survey screen. FIG. 8C is an image depicting another demographics survey screen. FIG. 8D is an image depicting a sleep and circadian details screen. FIG. 8E is an image depicting another sleep and circadian details screen. FIG. 8F is an image depicting another sleep and circadian details screen. FIG. 8G is an image depicting another sleep and circadian details screen. FIG. 8H is an image depicting a light sensitivity screen.

FIGs. 9A - 9D depict an exemplary calibration process within a UI for a phototherapy software application according to aspects of the present invention. FIG. 9A is an image depicting a calibration screen for the UI. FIG. 9B is an image depicting another calibration screen. FIG. 9C is an image depicting another calibration screen. FIG. 9D is an image depicting a calibration success screen. An exemplary calibration process may comprise an explanation of the calibration process for the user/patient/subject. In some embodiments, the calibration uses the camera to detect the user/patient' s face and eyes, so that during light therapy sessions the user/patient¹ s gaze is continuously monitored. This is used to dynamically calculate the circadian stimulus and lengthen the duration of the light therapy if the user doesn't look at the screen or is further than 17 inches away. In some embodiments, the user/patient may also receive live notifications to return to the session if they have been absent for >= 5 min during a session, or holding the device >17 inches for >= 5 min. FIG. 9D is an exemplary UI graphic which may be displayed in order to indicate to the user that the calibration is complete.

FIGs. 10A - IOC depict an exemplary content selector within a UI for a phototherapy software application according to aspects of the present invention. FIG. 10A is an image depicting a content selector screen for the UT. FIG. 10B is an image depicting another content selector screen. In some embodiments, the user/patient selects categories of articles they will be reading during their light therapy session. In some embodiments, the UI comprises one or more games or eye exercise games. Shown in FIG. IOC is an image depicting content (e g., a news article) displayed during the light therapy session. The format is the iOS XDR format which allows increased brightness to achieve CS >=0.3.

FIGs. 11 A - 1 IB depict exemplary analytics within a UI for a phototherapy software application according to aspects of the present invention. FIG. 11 A is an image depicting an analytics screen for the UI. FIG. 1 IB is an image depicting a logout screen. In some embodiments, exemplary analytics may comprise showing usage, progress on light therapy, and compliance with the sleep schedule.

Aspects of the present invention relate to a phototherapy method comprising an algorithm for modifying sleep behavior. In some embodiments, the algorithm comprises the step of prompting the user with one or more questions such as inquiring on tiredness, sleep schedule, sleep hygiene, happiness, and adjusting or performing the phototherapy based on the user’s answers.

In some embodiments, the algorithm comprises the step of capturing the age, gender, sleeping situation, number of offspring from the subject.

In some embodiments, the algorithm comprises the step of capturing one or more user needs, such as, but not limited to, improving sleep, improving energy, changing sleep schedule, changing sleep duration, time zone change.

In some embodiments, the user may be prompted with any user need or question selected from: I have trouble falling asleep/ staying asleep, I wake up during the night and have trouble falling back asleep, I wake up too early, I want to improve my productivity or energy levels, I often feel tired throughout the day, I get sleepy during the day and need more energy, When do you feel sleepy? In the morning? After lunch? In the early evening?, I want to change my schedule (get up earlier/later), I want to improve my mood, I want to establish more regular sleep and wake times

In some embodiments, the user or subject may enter one or more parameters or answer one or more questions selected from: desired wake, When is your bedtime typically?, at what time do you typically wake up in the morning?, How long does it take you to fall asleep at night?, How long do you lay awake in the middle of the night, in total, on average?, If you take naps 2x weekly or more, how long are the naps?, By how many minutes do your bedtime and wakeup time vary across the days of the week, on average?, At what time during the day do you feel most alert and productive?

In some embodiments, one or more parameters may be provided by the phototherapy system (e.g., system 100) including but not limited to: GPS coordinates, light intensity, light spectral composition, sleep, sleep start, nap start, nighttime movement, nighttime movement time, wake, subject motion, subject gaze, subject proximity.

In some embodiments, the algorithm comprises building a schedule comprising a wake time and a bed time, building a light schedule comprising a wake time followed by a phototherapy session, each of the wake time and the phototherapy session extending a respective duration of time, (e.g., a 15 min wake time, followed by a 30 min light session).

In some embodiments, the algorithm optionally comprises dimming or modifying a light source, display or screen before the bed time (e.g., to 30% Ih before bedtime + Apple Night shift 100%).

In some embodiments, the algorithm comprises optionally displaying one or more goal cards, or prompting the user with one or more questions, or user needs. In some embodiments, the algorithm comprises calculating feedback based on the prompts, parameters and user needs, and modifying the therapy session based on the feedback, such as is shown in “Output” and “Feedback” of Table 2 below.

Table 2 describes an exemplary UI workflow and algorithm that may be used with any disclosed phototherapy system and method. In some embodiments, the workflow and algorithm comprises subject onboarding, questionnaires and alerting. In some embodiments, the onboarding of a new subject comprises a first session wherein the user/patient creates an account. In some embodiments, the account may be an existing user account, such as an account created by a healthcare provide. In some embodiments, the user/patients logs in and fills out a mandatory survey to assess their demographic information, sleep, light and circadian habits as well as personal and medical needs. In some embodiments, the algorithm calculates an optimal sleep/wake schedule and light schedule for the user/patient and schedules the first light session. In some embodiments, the phototherapy system alerts the user when it is time to go to sleep and dim lights. In some embodiments, the next morning the phototherapy system alerts the user to start the phototherapy or light session and tracks adherence. In some embodiments, the user can choose news articles to read or other content such as email, messaging or social media during the phototherapy or light session. In some embodiments, after completing the phototherapy or session, the user can see usage and treatment feedback and statistics in the app.

Table 2: Application Algorithm

Aspects of the present invention may be operated with, or at least partially reside on one or more therapy or phototherapy systems or devices. The following U.S. Patent Applications are hereby incorporated by reference in their entirety: U.S. Application No. 17/125,932 titled “Display systems and methods for determining registration between a display and a user's eyes”, filed on December 27, 2020

U.S. Application No. 13/381, 385 titled “Light treatment system”, filed on June 24, 2010

U.S. Application No. 17/066,980 titled “Lighting system for circadian control and enhanced performance”, filed on October 19, 2020

U.S. Application No. 14/906,276 titled “System and method for providing light therapy and modifying circadian rhythm”, filed on July 8, 2014

U.S. Application No. 17/333,390 titled "Display with two thin film transistor substrates", filed on May, 28, 2021.

The disclosures of each and every patent, patent application, and publication cited herein are hereby each incorporated herein by reference in their entirety. While this invention has been disclosed with reference to specific embodiments, it is apparent that other embodiments and variations of this invention may be devised by others skilled in the art without departing from the true spirit and scope of the invention. The appended claims are intended to be construed to include all such embodiments and equivalent variations.

Claims

CLAIMS What is claimed is:

1. A phototherapy system, comprising: at least one radiative source configured to produce electromagnetic radiation (EMR) in one or more spectral bands; one or more sensors; and a controller communicatively connected to the at least one radiative source and the one or more sensors, the controller comprising a processor and memory storing instructions that when executed by the processor causes the processor to perform operations comprising: calculating a point of gaze of the subject based on data received from the one or more sensors; calculating a distance between the subject and the at least one radiative source based on data received from the one or more sensors; setting a brightness of the at least one radiative source to a brightness threshold when the calculated gaze of the subject is directed toward the at least one radiative source and the calculated distance is within an operational range of the at least one radiative source; calculating an exposure time of the subject based on the calculated point of gaze and the brightness; and setting the brightness of the at least one radiative source to a second brightness threshold when the exposure time exceeds a treatment duration; wherein the brightness of the at least one radiative source has a radiated power above a power threshold within a circadian wavelength range.

2. The system of claim 1, wherein the circadian wavelength range comprises wavelengths within the 420 nm - 680 nm range.

3. The system of claim 2, wherein the circadian wavelength range comprises wavelengths within the 460 nm - 480 nm range.

4. The system of claim 1, wherein the operational range of the at least one radiative source ranges between 1 inch and 48 inches.

5. The system of claim 1, wherein power to the at least one radiative source is provided for at least one duration of time, wherein the duration of time ranges between 1 min and 45 min.

6. The system of claim 1, wherein the at least one radiative source produces EMR comprising an illuminance ranging between 200 lux and 400 lux, and a Correlated Color (CCT) ranging between 6900 K and 7100 K.

7. The system of claim 6, wherein the illuminance is 358.6 lux, and the CCT is 7035.5 K.

8. The system of claim 1, wherein the at least one radiative source produces EMR with a Circadian Stimulus (CS) of at least 0.3.

9. The system of claim 1, wherein the at least one radiative source comprises a light source, a display or a screen, and the one or more sensors comprises a camera, a distance sensor and a light sensor.

10. The system of claim 1, further comprising a wearable device that at least partially houses at least one of the at least one radiative source, the one or more sensors, and the controller.

11. The system of claim 10, wherein the wearable device comprises an AR/VR headset.

12. A phototherapy method, comprising the steps of providing at least one radiative source configured to produce electromagnetic radiation (EMR) in one or more spectral bands, and one or more sensors with a controller communicatively connected to at least one radiative source and the one or more sensors, the controller comprising a processor and memory storing instructions that when executed by the processor causes the processor to perform operations comprising: calculating a point of gaze of the subject based on data received from the one or more sensors; calculating a distance between the subject and the at least one radiative source based on data received from the one or more sensors; setting a brightness of the at least one radiative source to a brightness threshold when the calculated gaze of the subject is directed toward the at least one radiative source and the calculated distance is within an operational range of the at least one radiative source; calculating an exposure time of the subject based on the calculated point of gaze and the brightness; and setting the brightness of the at least one radiative source to a second brightness threshold when the exposure time exceeds a treatment duration; wherein the brightness of the at least one radiative source has a radiated power above a power threshold within a circadian wavelength range.

13. The method of claim 12, further comprising the step of calculating a Circadian Stimulus (CS) scoring for the subject.

14. The method of claim 12, wherein the circadian wavelength range comprises wavelengths within the 460 nm - 480 nm range.

15. The method of claim 12, wherein the operational range of the at least one radiative source ranges between 1 inch and 48 inches.

16. The method of claim 12, wherein the exposure time of the subject ranges between 1 min and 60 min.

17. The method of claim 12, wherein the treatment duration is programmed on a schedule or with an algorithm.

18. The method of claim 12, wherein the at least one radiative source comprises a light source, display or screen and the one or more sensors comprises a camera, a distance sensor, and a light sensor.

19. The method of claim 12, further comprising the steps of measuring ambient EMR the subject is exposed to, and ceasing power to the at least one radiative source when ambient EMR is detected in one or more spectral bands above a predetermined threshold.

20. The method of claim 19, wherein the one or more spectral bands comprise EMR between the range of 420 nm and 680 nm.