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临床试验/NCT05382923
NCT05382923Unknown不适用

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

University of Arizona2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年7月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
36
试验地点
2
主要终点
Change (shift) in the acrophase of the rhythm of the median reaction time

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

Participants are informed that we are exploring different types of stimuli (including exercise, melatonin, and light) to help adjust to simulated jet lag.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • (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.

结局指标

主要结局

Change (shift) in the acrophase of the rhythm of the median reaction time

时间窗: 6.5 days

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

Change in sleep duration

时间窗: 5 days

Change in total sleep time assessed during night one in the lab and night 5 in the lab duration

Change (shift) in the acrophase of urinary 6-sulphatoxymelatonin (aMT6s) excretion

时间窗: 6.5 days

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

次要结局

  • Change (shift) in the acrophase of the Total Mood Disturbance composite scale of on the Profile of Mood States questionnaire(5 days)
  • Change (shift) in the acrophase of the Stanford Sleepiness Scale(5 days)
  • Change (shift) in the acrophase of the Wingate Anaerobic Performance Test(5 days)
  • Change in sleep recorded with z-machine(5 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shawn Youngstedt

Professor

Arizona State University

研究点 (2)

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