NCT00498563已完成不适用
Investigation to Determine the Effects of Mild Hypobaric Hypoxia on Sleep and Post-Sleep Neurobehavioral Performance
Oklahoma State University Center for Health Sciences2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2006年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Quality and quantity of sleep measured by actigraphy and polysomnography Neurobehavioral performance measured by Psychomotor Vigilance Test (PVT) and Automated Neurophysiologic Assessment Metrics Battery (ANAM)
研究概览
简要总结
Hypobaric hypoxia (decreased oxygen supply to body tissues due to low atmospheric pressure) caused by exposure to high altitude disrupts sleep. Sleep deprivation is associated with degraded post-sleep performance of neurobehavioral tasks. The lowest altitude at which sleep and/or post-sleep performance are affected is not known. The study hypothesis is that sleep and/or post-sleep performance of neurobehavioral tasks will occur due to hypobaric hypoxia at altitudes of 8,000 or less.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age 30 to 60 years
排除标准
- •sleep disorders or abnormal sleep patterns
- •mood or psychiatric disorders including claustrophobia
- •altitude exposure above 5,000 ft in the previous 2 months
- •born or raised at terrestrial altitude 5,000 ft or greater
- •conditions that would disqualify for FAA Medical Certificate
- •acute medical conditions
结局指标
主要结局
Quality and quantity of sleep measured by actigraphy and polysomnography Neurobehavioral performance measured by Psychomotor Vigilance Test (PVT) and Automated Neurophysiologic Assessment Metrics Battery (ANAM)
时间窗: 7 hours; 4 hours
次要结局
- Mood State measured by Profile of Mood States (POMS) Symptoms of altitude illness measured by Environmental Symptoms Questionnaire (ESQ IV) and Lake Louise Symptom Scores (LLS)(20 hours)
研究者
研究点 (2)
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