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NCT04921215 · ClinicalTrials.gov registry record · NA
Teen Sleep and Light Study
A NA study, sponsored by Rush University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 88
- Enrollment target
NCT04921215: Completed NA study, sponsored by Rush University Medical Center.
NCT04921215 is a NA study that has completed, run by Rush University Medical Center. The registered enrollment target is 88 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04921215, a NA study, has completed, sponsored by Rush University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 88 participants
- Enrollment target
Study Summary
Circadian clocks shift later (delay) with the progression of puberty; this shift contributes to late sleep onsets in older adolescents. Early school start times, however, force teenagers to awaken earlier than their spontaneous wake time and the opportunity for sleep shortens. Chronic circadian misalignment and sleep restriction are at their peak during late adolescence, and are associated with various negative outcomes. Morning bright light exposure from light boxes can shift rhythms earlier (phase advance) to facilitate earlier sleep onset, and reduce circadian misalignment and the associated risks. Studies of adults, however, indicate that restricted sleep and exposure to evening light due to late bedtimes make morning bright light less effective in producing advances. Pilot data collected from adolescents mimic this finding, but also suggest that staying awake late in normal household lighting and the subsequent sleep restriction before and during a 3-day morning bright light regimen, can shift the system in the wrong direction (phase delay). The overarching goal of this study is to examine the dose of sleep restriction and evening household light that prevents the desired phase advance to morning bright light in adolescents aged 14-17 years. Study 1 aims to construct a sleep restriction with normal household evening light dose-response curve to determine the point at which morning bright light begins to lose its effectiveness. The investigators hypothesize that the circadian system will advance with sufficient sleep, but with increasing sleep restriction/evening light, circadian rhythms will not shift or will delay despite the phase advancing morning bright light. Study 2 will test whether reducing evening light exposure by wearing sunglasses before bedtime during sleep restriction can facilitate phase advances. The main outcome measures to build the dose-response curve will be phase shifts of the central circadian clock marked by the dim light melatonin onset
Primary Outcome
Saliva sampling for the baseline DLMO will begin 8 hours before baseline bedtime and end 4 hours after baseline bedtime to capture the rise of endogenous melatonin. Sampling for the final DLMO will begin 11 hours before baseline bedtime and end 4 hours after baseline bedtime. Participants remain awake and seated in comfortable recliners in dim light, except when they need to use the adjoining restroom. Saliva samples are collected every 30 minutes using Salivettes. The samples are immediately ce
Interventions
- BEHAVIORAL Morning bright light
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2021-06-14 |
| Est. Completion | 2025-08-15 |
| Phase | NA |
What the finished NCT04921215 record still lists
NCT04921215 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Morning bright light is the first listed.
NCT04921215 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04921215 about?
NCT04921215 is a clinical study titled "Teen Sleep and Light Study". Circadian clocks shift later (delay) with the progression of puberty; this shift contributes to late sleep onsets in older adolescents. Early school start times, however, force teenagers to awaken earlier than their spontaneous wake time and the opportunity for sleep shortens. Chronic circadian misa...
What is the current status of trial NCT04921215?
This trial is currently completed. It is a NA study. The enrollment target is 88 participants. The study started on 2021-06-14. Estimated completion is 2025-08-15.
What interventions are being tested in trial NCT04921215?
The interventions under investigation include: Morning bright light (BEHAVIORAL).
Who is sponsoring clinical trial NCT04921215?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04921215's enrollment target sits among peer trials
88 972nd of 2000 higher than 1,027 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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