Longitudinal Patterns of Use of the Circadian OS iPad-Based Light App, With Optional Biomarker Collection
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Frequency of Circadian OS app (KairOS) use
研究概览
简要总结
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:
- How often, how long, and at what time of day do people use the app?
- What do people mostly do during light-delivery sessions?
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Frequency of Circadian OS app (KairOS) use
时间窗: From initiation of app use through the end of the app-exposure period, up to eight weeks
Number of light-delivery sessions completed per participant per week, captured by in-app telemetry.
Duration of app use: minutes of light exposure per session
时间窗: From initiation of app use through the end of the app-exposure period, up to eight weeks
Duration in minutes of each light-delivery session, captured by in-app telemetry.
Timing of app use relative to habitual wake time
时间窗: From initiation of app use through the end of the app-exposure period, up to eight weeks
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.
Context of app use
时间窗: From initiation of app use through the end of the app-exposure period, up to eight weeks
Concurrent on-screen activity during light-delivery sessions, captured by in-app telemetry.
次要结局
- Participant-reported feedback on the app experience, usability, and perceived effects(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(From initiation of app use through the end of the app-exposure period, up to eight weeks)
- Drop-off and return-to-use patterns(From initiation of app use through the end of the app-exposure period, up to eight weeks)
- System Usability Scale (SUS) score(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(From initiation of app use through the end of the app-exposure period, up to eight weeks)
- Root-Cause Category of Identified Use Errors(From initiation of app use through the end of the app-exposure period, up to eight weeks)