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Clinical Trial Summary

The aims of this study are to compare 3 different treatments for circadian adjustment to a laboratory protocol which will mimic westward air travel across 8 time zones. One treatment will involve simply following the new schedule for 3 days. Another treatment will also involve exposure to bright light for 1 hour per day. A third treatment will involve exposure to bright light + exercise for 1 hour per day + consuming a melatonin tablet. Adjustment to the shifted schedule will be assessed by comparing measures of sleep, mood, mental performance, physical performance, and timing of melatonin across the 3 treatment conditions.


Clinical Trial Description

Design Overview. Following a 1 week home baseline, N=36 young adults will spend 6 days in the laboratory (Figure 3 and Table 1). Following am 8 h baseline polysomnographic recording (PSG) on Night 1, participants will undergo a 26 h baseline circadian assessment via an ultrashort sleep-wake protocol involving 2 h wake intervals and 1 h sleep intervals, repeated throughout the protocol. Following baseline circadian assessment, participants will be placed on a 16 h wake-8 h sleep schedule in which the wake-sleep and light-dark schedule is delayed 8 h for 3 days (analogous to traveling 8 time zones west). Participants will be randomized to one of 3 treatments (n=12 per treatment) administered each of the 3 days of the shifted schedule: (1) placebo control, (2) bright light, and (3) bright light + exercise + melatonin. PSG recording will occur on the last night of the shifted schedule, followed by an end-of-study 26 h ultrashort sleep wake schedule. On baseline Day 1 and Days 2-3 of the shifted schedule, sleepiness, mood, and mental performance will be assessed every 3 h during wake. During all four 8 h sleep periods, sleep will also be recorded with the Z-machine, which assesses sleep stages from 3 EEG electrodes. During the ultrashort sleep-wake schedules, mental performance, physiological performance, urinary aMT6s, mood, and sleepiness will be measured around-the-clock. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05382923
Study type Interventional
Source University of Arizona
Contact Shawn Youngstedt, PhD
Phone 803-767-3208
Email youngstedt@email.arizona.edu
Status Recruiting
Phase N/A
Start date July 10, 2021
Completion date May 2023