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临床试验/NCT00438438
NCT00438438已完成不适用

"Interaction of Chronic Sleep Restriction and Circadian Misalignment on Sleep and Neuro-cognitive Performance"

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2006年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
2
主要终点
Multiple Object Tracking

研究概览

简要总结

The primary objectives of the proposed experimental and modeling efforts are to quantify the influences of acute sleep deprivation (short-term homeostatic), chronic sleep restriction (long-term homeostatic), circadian rhythmicity, and their interactions on neurocognitive performance and to develop a new model of sleep homeostasis that can predict the effects of chronic sleep restriction. This model will be based on the underlying neuroanatomy and neurophysiology. This new model will facilitate optimization of human performance in operational settings, such as are seen in military operation and other work environments.

详细描述

This protocol involves a baseline period consisting of 14 hours of wakefulness and 10 hour nocturnal sleep episodes each 24 hours. This is followed by a forced desynchrony regimen spanning 21 calendar days and consisting of 12 cycles ("days") of a 42.85-hour wake:bedrest schedule. In each 42.85 hour cycle, there are 32.85 hours of scheduled wakefulness and 10 hour sleep opportunities. This will allow assessment of the independent contributions of circadian phase and homeostatic sleep pressure on sleep and neurobehavioral performance. This forced desynchrony regimen is followed by 10 recovery days consisting of 14 hours of wakefulness and 10 hour nocturnal sleep episodes each 24 hours.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-35 years old
  • Medically healthy

排除标准

  • Sleep disorder
  • Psychiatric illness
  • Chronic medical condition
  • No prescription or Non-prescription medications

结局指标

主要结局

Multiple Object Tracking

时间窗: 38 days

Flanker Task

时间窗: 38 days

Sleep Stage

时间窗: 38 days

Circadian Phase (melatonin rhythm)

时间窗: 38 days

Psychomotor Vigilance Task

时间窗: 38 days

Digit Symbol Substitution Task

时间窗: 38 days

Addition Task

时间窗: 38 days

Karolinska Sleepiness Scale

时间窗: 38 days

Karolinska Drowsiness Test

时间窗: 38 days

Mood Scales

时间窗: 38 days

次要结局

未报告次要终点

研究者

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

Elizabeth B. Klerman

Associate Professor, Associate Physician

Brigham and Women's Hospital

研究点 (2)

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