NCT00716521已完成1 期
Subject- And Investigator-Blinded, Sponsor-Open, Randomized, Single-Dose, Placebo-Controlled, 3-Way Crossover Study To Study Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- onset to persistent sleep
研究概览
简要总结
This study will assess the feasibility of conducting sleep studies in a clinical research unit environment. In addition, the sensitivity of polysomnography and mobile actigraphy technologies will be compared for evaluating sleep stages and sleep architecture.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-55
- •BMI 18-30 kg/m2
- •body weight > 50 kg
排除标准
- •no history of sleep disorder
- •no concurrent medications
- •no alcohol use
- •no medical issues
- •no smoking
研究组 & 干预措施
Placebo
Placebo Comparator
groups of 3-4 subjects for overnight polysomnography assessments
干预措施: placebo (Drug)
Low dose Zolpidem
Experimental
干预措施: zolpidem (Drug)
High dose zolpidem
Experimental
干预措施: zolpidem (Drug)
结局指标
主要结局
onset to persistent sleep
时间窗: minutes
次要结局
- awakenings after sleep onset(minutes)
研究者
研究点 (1)
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