Facilitating Adjustment to Simulated Jet Lag

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Circadian Acclimatization of Performance, Sleep, and 6-sulphatoxymelatonin Using Multiple Phase-Shifting Stimuli

Conditions
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Circadian Rhythm Sleep Disorder, Jet Lag Type

Intervention / Treatment
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* Behavioral: Bright Light
* Behavioral: Bright Light + Exercise + Melatonin
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-45 years At least moderate level of habitual physical activity (twice per week, 20 min of aerobic exercise at 60% of maximal effort or higher Exclusion Criteria: (1)Having more than one risk factor for coronary artery disease: (2) having any symptom or sign of cardiopulmonary disease; (3) recent shift-work experience (previous 2 months) or travel across multiple time zones (previous 4 weeks); (4) having an abnormal sleep-wake schedule (i.e., reported bedtime before 9:00 pm or after 2:00 am; wake time before 5:00 am or after 10:00 am); (5) being an extreme night owl or morning lark, as assessed by the Horne-Ostberg Mornngness-Eveningness Scale;70 (6) having a high risk sleep apnea or another sleep disorder; (7) depressed mood [Center for Epidemiologic Studies-Depression Scale (CES-D) > 16];71 (7) use of medications likely to distort melatonin excretion or cardiovascular responses to exercise; (8) use of sleeping pills more than 1 night per week; (9) having high sensitivity to light; (10) abuse of alcohol or drugs (amount per week; related problems such as missing work); (11) any physical or mental health condition that would contraindicate participation in exercise or other rigors of the experiment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Random assignment to one of three conditions
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bright Light Alone<br>Bright light administered with Re-Timer glasses for 1 hour on 3 consecutive days. Following the 8 hour delay of the light/dark and sleep/wake cycle in the laboratory, the light will be administered, on average at 5:30-6:30 pm, 7:00-8:00 pm, and 9:30-10:30 pm, respectively on these three days. | Behavioral: Bright Light<br>* 3 consecutive days of 1 hour bright light<br>* Other names: Bright Light Treatment;|
| Experimental: Bright Light + Exercise + Melatonin<br>Bright light will be administered with Re-Timer glasses for 1 hour on 3 consecutive days. Following the 8 hour delay of the light/dark and sleep/wake cycle in the laboratory, the light will be administered, on average at 5:30-6:30 pm, 7:00-8:00 pm, and 9:30-10:30 pm, respectively on these three days. Exercise (1 hour at 65-75% heart rate reserve) will be administered on 3 consecutive, at 1:30-2:30 pm, 4:00-5:00 pm, and 6:30-7:30 pm on these days. Melatonin (0.5 mg) will be administered at 6 am, 8:30 am, and 11:00, on the 3 days. | Behavioral: Bright Light + Exercise + Melatonin<br>* 3 consecutive days of bright light, exercise, and melatonin<br>* Other names: Bright Light Treatment + Treadmill Exercise + Melatonin;|
| Placebo Comparator: Placebo Control<br>Dim red light will be administered with Re-Timer glasses for 1 hour on 3 consecutive days. Following the 8 hour delay of the light/dark and sleep/wake cycle in the laboratory, the light will be administered, on average at 5:30-6:30 pm, 7:00-8:00 pm, and 9:30-10:30 pm, respectively on these three days. Placebo tablets (0.5 mg) will be administered at 6 am, 8:30 am, and 11:00, on the 3 days. | Behavioral: Control<br>* 3 consecutive days of dim red light + light stretching + placbo<br>* Other names: Placebo Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change (shift) in the acrophase of urinary 6-sulphatoxymelatonin (aMT6s) excretion | Change (shift) in the cosine fitted peak for the assessments (every 90 min) during lab days 2-3 compared with the assessments taken during days 6-7 | 6.5 days | 
| Change (shift) in the acrophase of the rhythm of the median reaction time | Change (shift) in the cosine fitted peak for the assessments (psychomotor vigilance, every 3 h) taken during days 2-3 compared with the assessments taken during days 6-7 | 6.5 days | 
| Change in sleep duration | Change in total sleep time assessed during night one in the lab and night 5 in the lab duration | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change (shift) in the acrophase of the Total Mood Disturbance composite scale of on the Profile of Mood States questionnaire | Change (shift) in the cosine-fitted peak of the rhythm of total mood disturbance assessed during days 2-3 compared with total mood disturbance assessed during days 6-7 | 5 days | 
| Change (shift) in the acrophase of the Stanford Sleepiness Scale | Change (shift) in the cosine-fitted peak of the rhythm of the Stanford Sleepiness Scale assessed during days 2-3 compared with the Stanford Sleepiness Scale mood disturbance assessed during days 6-7 | 5 days | 
| Change (shift) in the acrophase of the Wingate Anaerobic Performance Test | Change (shift) in the cosine-fitted peak of the rhythm of the Wingate Anaerobic Performance Test assessed on days 2-3 and day 6-7. | 5 days | 
| Change in sleep recorded with z-machine | Z machine recorded sleep with electrodes on the mastoid bones. Change in sleep assessed in eight 1-h sleep intervals on days 2-3 and days 6-7 | 5 days |