CClinicalTrials.gg
Enrolling by invitationNCT07744711Updated Aug 4, 2026

Real-World Use of an iPad-Based Light Therapy App, With Optional Biomarker Collection

An interventional study of Circadian OS iPad-based light app in Circadian Rhythms, sponsored by Circadian OS, Inc. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by Circadian OS, Inc · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study looks at how adults use an iPad-based light app in everyday life.

Light is the main signal that sets the body's internal clock, which controls daily rhythms in sleep, alertness, and many other body systems. Indoor living means many people do not get bright light at a consistent time each day.

The app uses the iPad screen to deliver light while people watch videos, read, or browse. It suggests about one hour of use per day, started within about two hours of waking. It does not require anyone to follow that schedule, and no one is locked out for using it more, less, or at other times. The app shows people when they are positioned to receive the intended light, records how the app is used, and asks short questions about sleep.

The main questions this study aims to answer are:

  1. How often, how long, and at what time of day do people use the app?
  2. What do people mostly do during light-delivery sessions?
  3. What do people think of the app, and how easy is it to use?

Participants will use the app on an iPad for up to eight weeks, answer short questions about their sleep and how they feel, and share feedback about their experience.

Participants may also choose to take part in optional sub-studies. They can wear a device the sponsor provides to record movement, light exposure, and skin temperature, or share data from a wearable device they already use. They can also give blood, saliva, or urine samples, which researchers will use to describe daily patterns in clock-related genes and other markers. These sub-studies are entirely exploratory and voluntary, and participants can take part in the main study without them.

Participants will not receive results from any samples they give. This study does not provide medical treatment, and it is not designed to determine whether the app treats or improves any medical condition.

Read the detailed description

This is a single-site, longitudinal study evaluating how adults use KairOS, an iPad-based light application developed by Circadian OS, Inc., in everyday life for up to eight weeks. Participants are encouraged to use the app for approximately 60 minutes daily within two hours of waking, but use is not enforced. Zero-use stretches, partial weeks, and re-engagement after a gap are recorded as participation data rather than protocol deviations. App telemetry, sleep logs, and participant feedback are used to characterize patterns of use and overall usability. Participants may also opt into an exploratory biomarker sub-study involving collection of blood, saliva, or urine samples; no laboratory results are returned to participants. Other optional activities include actigraphy, light-exposure monitoring, and moderated task-observation sessions.

02

Conditions studied

  • Circadian Rhythms

Keywords

  • chronotype
  • phototherapy
  • chronotherapy
  • photoentrainment
  • light therapy
  • real-world evidence
  • patterns of use
  • circadian medicine
03

In context

Lead sponsor

This is the only study on the registry with Circadian OS, Inc as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adult 18 years of age or older
  • Able to read, understand, and provide written informed consent in English
  • Has access to a compatible iPad capable of running the study app for the duration of the exposure period, or is willing to use a Sponsor-supplied iPad
  • U.S. resident, able to be in the NYC metropolitan area for the study
  • Member of the Sponsor's network (friends, family, advisors, investors, employees, or contractors)
  • If opting in to the biomarker sub-study: weighs at least 110 lb (50 kg), and meets standard venipuncture eligibility on the day of collection

Exclusion criteria

Exclusion Criteria:

  • Diagnosed bipolar disorder, or history of light-induced manic or hypomanic episodes
  • Pregnant, attempting to become pregnant, or breastfeeding
  • Diagnosed photosensitivity disorder, retinal disease, or use of medications known to cause significant photosensitivity, at investigator discretion based on disclosed medications
  • Currently using prescription light therapy, or actively enrolled in another light-related research study
  • Unable to consent for themselves (participants requiring enrollment by a legally authorized representative are not eligible)
  • Biomarker sub-study only: acutely unwell, febrile, or reporting acute infectious symptoms on the study day
  • Biomarker sub-study only: known bleeding diathesis, anticoagulant use other than low-dose aspirin, severe needle phobia, or whole-blood or plasma donation within the prior two weeks
  • Biomarker sub-study only: member of the study or laboratory team who would otherwise process their own sample
  • Any condition that, in the judgment of the investigator or attending phlebotomist or nurse, would make participation unsafe
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Circadian OS Light App (KairOS)

    Participants receive the investigational Circadian OS iPad-based light app and use it in their normal environment over a defined exposure period. App onboarding presents a recommended use envelope of approximately 60 minutes per day within approximately 2 hours of habitual wake time, anchored to the participant's Munich ChronoType Questionnaire response. Use is not enforced: the app does not lock out participants who use it less, more, or outside the recommended window, and non-use is recorded as participation data. Participants complete brief in-app check-ins on sleep and experience, plus periodic usability surveys. Optional sub-studies (actigraphy, biomarker collection, moderated human-factors observation) are independently elected by participants within this single arm.

    Device: Circadian OS iPad-based light app

Interventions

  • DeviceCircadian OS iPad-based light app

    Software-based light-delivery platform running on an off-the-shelf iPad. The app uses the display to deliver light targeting a specified circadian stimulus (CS ≥ 0.3), integrating spectrum and intensity at the eye. It runs closed-loop: screen luminance is calibrated in advance, the iPad camera tracks viewing distance and gaze direction, and the app computes the dose reaching the eye in real time, signaling whether the user is positioned to receive it. Session start-time recommendations are anchored to each participant's habitual wake time, derived from the Munich ChronoType Questionnaire. Onboarding presents a recommended envelope of approximately 60 minutes per day within approximately 2 hours of habitual wake. Use is not enforced and the app does not lock out off-envelope use. Participants use the app while streaming, reading, or browsing as they normally would.

    Also known as: KairOS, Circadian OS app

06

What researchers measure

Primary outcomes

  1. Frequency of Circadian OS app (KairOS) use

    Number of light-delivery sessions completed per participant per week, captured by in-app telemetry.

    Time frame: From initiation of app use through the end of the app-exposure period, up to eight weeks

  2. Duration of app use: minutes of light exposure per session

    Duration in minutes of each light-delivery session, captured by in-app telemetry.

    Time frame: From initiation of app use through the end of the app-exposure period, up to eight weeks

  3. Timing of app use relative to habitual wake time

    Start time of each light-delivery session, expressed as hours elapsed since the participant's habitual wake time, as measured by the Munich Chronotype Questionnaire completed at baseline.

    Time frame: From initiation of app use through the end of the app-exposure period, up to eight weeks

  4. Context of app use

    Concurrent on-screen activity during light-delivery sessions, captured by in-app telemetry.

    Time frame: From initiation of app use through the end of the app-exposure period, up to eight weeks

Secondary outcomes

  1. Participant-reported feedback on the app experience, usability, and perceived effects

    Structured and free-text participant feedback on the app experience, usability, and perceived effects, including the Perceived Effects Scale (Compared to Before the Study), a study-specific 5-point Likert measure (range 1-5, higher scores indicate a better perceived outcome; 1 = Much worse, 2 = Somewhat worse, 3 = No change, 4 = Somewhat better, 5 = Much better).

    Time frame: Weekly during the app-exposure period and at the end of the app-exposure period, up to eight weeks

  2. Self-reported sleep and circadian-rhythm parameters during the exposure period

    Participant-reported sleep parameters captured through an in-app daily sleep log during the exposure period, including bedtime, wake time, nighttime awakenings, napping, and sleep quality. Weekly participant check-ins capture sleep quality and daytime alertness relative to usual.

    Time frame: From initiation of app use through the end of the app-exposure period, up to eight weeks

  3. Drop-off and return-to-use patterns

    Consecutive zero-use days per participant, partial weeks of use, and re-engagement events following a use gap.

    Time frame: From initiation of app use through the end of the app-exposure period, up to eight weeks

  4. System Usability Scale (SUS) score

    Participant-completed 10-item System Usability Scale, scored 0-100, with higher scores indicating better perceived usability.

    Time frame: End of Week 1 and end of the app-exposure period; a single administration is done at the end of Week 1 when the app-exposure period is one week

  5. Number of Use Errors Identified During App Use

    Use errors identified from in-app telemetry and participant-reported problems, documented with description and frequency.

    Time frame: From initiation of app use through the end of the app-exposure period, up to eight weeks

  6. Root-Cause Category of Identified Use Errors

    Identified use errors are categorized by root cause (perception, cognition, or action) per human-factors methodology, based on in-app telemetry and participant-reported problems.

    Time frame: From initiation of app use through the end of the app-exposure period, up to eight weeks

07

Study locations

1 site
  • SOSV
    New York, New York 10001, United States
08

References and documents

Publications

  • Patke A, Young MW, Axelrod S. Molecular mechanisms and physiological importance of circadian rhythms. Nat Rev Mol Cell Biol. 2020 Feb;21(2):67-84. doi: 10.1038/s41580-019-0179-2. Epub 2019 Nov 25. PubMed 31768006 ↗
  • Allada R, Bass J. Circadian Mechanisms in Medicine. N Engl J Med. 2021 Feb 11;384(6):550-561. doi: 10.1056/NEJMra1802337. No abstract available. PubMed 33567194 ↗
  • Roenneberg T, Pilz LK, Zerbini G, Winnebeck EC. Chronotype and Social Jetlag: A (Self-) Critical Review. Biology (Basel). 2019 Jul 12;8(3):54. doi: 10.3390/biology8030054. PubMed 31336976 ↗
  • Rea MS, Nagare R, Figueiro MG. Modeling Circadian Phototransduction: Retinal Neurophysiology and Neuroanatomy. Front Neurosci. 2021 Feb 5;14:615305. doi: 10.3389/fnins.2020.615305. eCollection 2020. PubMed 33613175 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared outside the Sponsor. Per the study protocol, no coded or identified data are shared outside the Sponsor, and no biospecimens are shipped to any external laboratory. The Sponsor will return to the IRB before any external sharing is contemplated. Participant consent does not authorize sharing of individual participant data outside the study team.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07744711
Lead sponsor
Circadian OS, Inc
Responsible party
Sponsor
First posted
Aug 4, 2026
Start date
Jul 17, 2026
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Aug 4, 2026

Study contacts

Sofia Axelrod, PhD
principal investigator · Circadian OS, Inc

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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