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

Официальное название

Longitudinal Patterns of Use of the Circadian OS iPad-Based Light App, With Optional Biomarker Collection

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Circadian 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 ancho

Первичные конечные точки

• Frequency of Circadian OS app (KairOS) use [Срок оценки: From initiation of app use through the end of the app-exposure period, up to eight weeks]
• Duration of app use: minutes of light exposure per session [Срок оценки: From initiation of app use through the end of the app-exposure period, up to eight weeks]
• Timing of app use relative to habitual wake time [Срок оценки: From initiation of app use through the end of the app-exposure period, up to eight weeks]
• Context of app use [Срок оценки: From initiation of app use through the end of the app-exposure period, up to eight weeks]

Вторичные конечные точки (6)

• Participant-reported feedback on the app experience, usability, and perceived effects [Срок оценки: Weekly during the app-exposure period and at the end of the app-exposure period, up to eight weeks]
• Self-reported sleep and circadian-rhythm parameters during the exposure period [Срок оценки: From initiation of app use through the end of the app-exposure period, up to eight weeks]
• Drop-off and return-to-use patterns [Срок оценки: From initiation of app use through the end of the app-exposure period, up to eight weeks]
• System Usability Scale (SUS) score [Срок оценки: 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]
• Number of Use Errors Identified During App Use [Срок оценки: From initiation of app use through the end of the app-exposure period, up to eight weeks]
• Root-Cause Category of Identified Use Errors [Срок оценки: From initiation of app use through the end of the app-exposure period, up to eight weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• SOSV — New York

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 33613175

Идентификаторы

NCT: NCT07744711 · COS-20262058

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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