The Effect of Acute Hypnotic Intake Before a Night at High Altitude on Cognitive and Motor Performances
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Cognitive performance assessed using Simon cognitive test
研究概览
简要总结
This study aims to determine the effect of acute hypnotic intake (Zolpidem) on sleep, cognitive and motor performances and on acute mountain sickness symptoms at high altitude. Healthy subjects will be evaluated on 4 occasions (twice at sea level and twice at high altitude), after hypnotic or placebo intake. Following an early wake-up (01:00), symptoms, cognitive and motor performances will be assessed to determine potential residual effects of Zolpidem within such conditions.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No sojourn above 2500 m during the past 2 months
- •Coffee intake < 3 cups per day
- •Non-smoker
排除标准
- •Respiratory, cardiovascular, metabolic or neuromuscular diseases
- •Psychiatric disorders
- •Use of hypnotics within the past year
- •Dependence syndrome (alcool, drugs, etc)
- •Severe insomnia or somnolence
研究组 & 干预措施
Zolpidem Normoxia
Acute zolpidem intake at sea level
干预措施: Zolpidem (Drug)
Placebo Normoxia
Acute placebo intake at sea level
干预措施: Placebo (Drug)
Zolpidem Hypoxia
Acute zolpidem intake at high altitude
干预措施: Zolpidem (Drug)
Placebo Hypoxia
Acute placebo intake at high altitude
干预措施: Placebo (Drug)
结局指标
主要结局
Cognitive performance assessed using Simon cognitive test
时间窗: 4 hours after drug/placebo intake
Simon cognitive test
次要结局
未报告次要终点