Clinical Trials Logo

Clinical Trial Summary

Chronic circadian misalignment and sleep restriction peak during late adolescence, and are associated with morning daytime sleepiness, poor academic performance, conduct problems, depressed mood, suicidal ideation, substance use, insulin resistance, and obesity. Bright light exposure from light boxes can shift rhythms earlier (phase advance) to facilitate earlier sleep onset and reduce morning circadian misalignment and the associated risks. To phase advance circadian rhythms, the investigators' PRCs showed that the ideal time to begin light exposure was slightly before wake-up time and light should be avoided around bedtime because this is when light produces maximum phase delay shifts. An unexpected finding from these results, however, was a second advancing region in the afternoon (~6 to 9 h after habitual wake-up time) suggesting that afternoon light may have more circadian phase advancing ability than traditionally thought. The overall goal of this mechanistic study is to follow-up on the unexpected PRC findings and test whether individually-timed afternoon light alone and in combination with morning bright light can shift circadian rhythms earlier in older adolescents. Four groups will be compared in a randomized parallel group design: afternoon bright light, morning bright light, morning + afternoon bright light, and a dim room light control. Adolescents will complete a 2-week protocol. After a baseline week with a stable sleep schedule, adolescents will live in the laboratory for 7 days. Sleep/dark and the time of bright light exposure will gradually shift earlier. Bright light (~5000 lux) will be timed individually based on his/her stable baseline sleep schedule. The first 3-h morning bright light exposure will begin 1 h before wake on the first morning. The first 3-h afternoon bright light exposure will begin 5 h after wake. The morning + afternoon exposures will begin at the same times, but each exposure will be 1.5 h so that a total of 3 h of bright light per day will be given to each group except the dim light control group. Phase shifts of the circadian clocks marked by the dim light melatonin onset (DLMO) is the main outcome. Investigators hypothesize that afternoon bright light will work synergistically with morning bright light to produce larger shifts than morning or afternoon bright light alone. These data could challenge the current understanding of how to use bright light to shift circadian rhythms earlier.


Clinical Trial Description

Participants will complete a 14-day protocol. On days 1-7, participants will sleep at home on a stable sleep schedule that requires 9 h of time in bed in the dark. This will ensure that participants are not sleep deprived before beginning the lab sessions. Wake time will be the average of the self-reported wake-up time (± 15 mins) before the study begins measured from pre-study sleep logs collected for a week or more. Bedtime will be 9 h before wake-up time. A device worn on the wrist that measures activity (actigraph), sleep diaries, and daily telephone messages will monitor compliance to the sleep schedule. Participants will visit the lab at least once during this week to download and review their data. If participants are not compliant to the sleep schedule, they will be dropped from the study. On days 8-13, participants will live in the laboratory for seven days. On day 8, participants will arrive at the laboratory in the afternoon, and shortly after, will begin a baseline circadian phase assessment to determine baseline dim light melatonin onset (DLMO), a reliable marker of the circadian timing system. On day 9, participants will sleep on their stable 9-h sleep schedule in the laboratory. Their 9-h fixed sleep schedule will be shifted by 1 h per day over 3 days. Participants will sleep in dark bedrooms in the lab. During scheduled wake, participants will remain awake in normal dim room light except during bright light sessions, when light will range from 5000 to 7000 lux. Study groups will differ by the light exposure they receive during the lab sessions. In the afternoon bright light (ABL) group, participants will be exposed to 3 h of bright light on 3 consecutive afternoons. On the first day (day 10), light boxes will be turned on 5 h after fixed wake-up time. Then, the start of the light exposure will move 1 h earlier each day. In the morning bright light (MBL) group, participants will be exposed to 3 consecutive mornings of 3 h of bright light. On the morning of day 11, the 3-h bright light exposure will begin 1 h before their stable wake-up time. In the morning + afternoon bright light (MBL + ABL) group, bright light will begin at the same times as the ABL and MBL groups and participants will received the same duration of bright light per day (3 h) as the ABL and MBL groups because the duration of each exposure will be 1.5 h instead of 3 h. Both bright light exposures will move 1 h earlier on subsequent days. In the room light control group, participants will complete the same 7-day lab session, except remain in dim room lighting. All participants will complete a final circadian phase assessment at the end of the 7-day lab session (day 13). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04753190
Study type Interventional
Source Rush University Medical Center
Contact Stephanie J Crowley, PhD
Phone (312) 563-4783
Email Stephanie_J_Crowley@Rush.edu
Status Recruiting
Phase N/A
Start date August 22, 2022
Completion date June 2026

See also
  Status Clinical Trial Phase
Completed NCT04044495 - Sleep, Rhythms and Risk of Alzheimer's Disease N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Completed NCT05017974 - Research on Improving Sleep During Pregnancy N/A
Recruiting NCT05206747 - Ottawa Sunglasses at Night for Mania Study N/A
Enrolling by invitation NCT04253054 - Chinese Multi-provincial Cohort Study-Beijing Project
Completed NCT04513743 - Ultra Long-Term Sleep Monitoring Using UNEEG™ Medical 24/7 EEG™ SubQ N/A
Completed NCT03251274 - Bath Machine on Sleep Quality in Nursing Home N/A
Completed NCT04102345 - Lavender vs Zolpidem Sleep Quality During Diagnostic PSG Early Phase 1
Completed NCT03725943 - Comparison of Dreem to Clinical PSG for Sleep Monitoring in Healthy Adults N/A
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Completed NCT04562181 - Consistency Evaluation of the qCON, qNOX Indices and Bispectral Index N/A
Completed NCT05102565 - A Dyadic Telehealth Program for Alzheimer's Patients/Caregivers N/A
Completed NCT05576844 - Ai Youmian (Love Better Sleep) for People Living With HIV N/A
Enrolling by invitation NCT04688099 - Synovial Fluid Sleep Study
Recruiting NCT04171245 - Prescribing Laughter for Sleep and Wellbeing in UAE University Students N/A
Completed NCT03758768 - The Effects of a Blue Monochromatic Light Intervention on Evening-type Individuals' Sleep and Circadian Rhythms N/A
Completed NCT03163498 - Evaluation of Sleep Pattern and Mood Profile in Hypertensive Patients
Completed NCT04093271 - Investigating the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep Phase 1
Completed NCT03673397 - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression N/A
Completed NCT04120363 - Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations Phase 4