NCT03373201已完成3 期
Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Total Sleep Time in the First Two Thirds of the Night
研究概览
简要总结
The aim of this study is to investigate tasimelteon vs. placebo on sleep in healthy individuals after a phase advance in jet lag type insomnia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability and acceptance to provide written consent, fluent in English;
- •Healthy subjects with no medical, psychiatric or current sleep disorders;
- •Men or women between 18-75 years;
- •Body Mass Index of ≥ 18 and ≤ 30 kg/m2.
排除标准
- •Major surgery, trauma, illness or immobile for 3 or more days within the past month;
- •Pregnancy or recent pregnancy (within 6 weeks);
- •A positive test for drugs of abuse at the screening or evaluation visit.
研究组 & 干预措施
Tasimelteon
Experimental
干预措施: Tasimelteon (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Total Sleep Time in the First Two Thirds of the Night
时间窗: 1 Day
Total sleep time during the first 2/3 of the night following an 8-hour phase advance bedtime, as measured by PSG. This is representative of trans meridian travel across 8 time zones.
次要结局
- Next Day Alertness as Measured by the Karolinska Sleepiness Scale (Night 1 Average Score)(1 Day)
- Total Sleep Time(1 Day)
- Latency to Persistent Sleep(1 Day)
- Wake After Sleep Onset(1 Day)
- Next Day Alertness as Measured by the Visual Analogue Scale (Night 1 Average Score)(1 Day)
研究者
研究点 (1)
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