NCT03459300已完成不适用
Importance of Sleep Deprivation in Differential Diagnosis of Primary Hypersomnia in Reference Centers Rare Hypersomnia
Centre d'Investigation Clinique et Technologique 8051 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年2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
- 100
- 试验地点
- 1
- 主要终点
- mean total sleep time
研究概览
简要总结
7 to 14 days actimetry recording in order to exclude sleep deprivation just before hospitalisation for differential diagnosis of hypersomnia
详细描述
This is an observational study
Urine drug screening will also be performe
The suty includes four centers in France
The study duration is of one year
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged > 18 years
- •Patient with a sleepiness evoking a primary hypersomnia
- •Epworth sleepiness scale > 10
- •Information note signed
排除标准
- •Patient with type 1 or 2 narcolepsy and/or known hypersomnia
- •Frank cataplexy
- •Not stable metabolic, neurological or psychiatric disease
- •Patient treated by a medicine acting on the central nervous system
- •Patient having a shift work or having made a transmeridian flight of more than 3 hours lag in the previous month the research
- •Non affiliation to social security
- •Pregnancy
- •Patient under guardianship or curatorship
结局指标
主要结局
mean total sleep time
时间窗: 7-14 days before hospitalisation
mean total sleep time as measured by actimetry durind the 7 - 14 days before hospitalisation
次要结局
未报告次要终点
研究者
研究点 (1)
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