EUCTR2013-000078-30-IT进行中（未招募）不适用
Evaluation in patients affected by middle of the night (MONT) awakenings using different dosages of triazolam
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Valeas SpA
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Night-time awakening (>= 5 nights/week) followed by a difficult to fall asleep in men or female aged over 18 years.
- •- Latency to sleep after the night-time awakening: > 45 minutes
- •- No difficult to fall asleep at the evening (Sleep Latency < 30 minutes)
- •- Moderate use of alcool (max 2 glasses of wine/day), caffeine (not after 5 pm and max 2 cups/day) e nicotine (max 10 cigarettes/day)
- •- No pregnancy, if woman
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •- obstructive sleep apnoea syndrome (OSA),
- •- restless leg syndrome
- •- shift worker
- •- any pathology influncing the sleep
- •- psychiatric disorder according to ASSE 1 – DSM IV-TR
- •- known hyperseitivity to triazolam
- •- use of any central nervous system medication or other medications known to affect the sleep/wake function (washout at least of 7 days)
研究者
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