NCT03681327已完成不适用
Sleep Infra-slow Oscillations III: an Observational Study in Healthy Subjects and Patients With Sleep Disorders With and Without Closed-loop Stimulation During Sleep
Neurocenter of Southern Switzerland2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2018年10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
- 17
- 试验地点
- 2
- 主要终点
- Arousal probability
研究概览
简要总结
In young healthy subjects, we will apply sensory stimuli at specific times during sleep to evaluate the probability that the stimulus evokes an arousal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willingness to participate and written informed consent
- •Aged 20 to 40 years at the time of screening
- •Body mass index (BMI) ≤ 30
排除标准
- •Pregnancy or breast feeding at the time of screening
- •Sleep related breathing disorders
- •Any other sleep related breathing disorder according to AASM criteria
- •Current history of psychiatric disorders according to DSM-V
- •Current chronic treatment that may affect sleep
- •Any significant neurological disorder or other medical disease that may affect sleep
- •Any unstable medical condition
- •Any clinically significant sleep disorder
结局指标
主要结局
Arousal probability
时间窗: 8 hours
Number stimuli that are followed by an EEG arousal divided by the total number of stimuli
次要结局
未报告次要终点
研究者
Stephany Fulda
Stephany Fulda, Principal Investigator
Neurocenter of Southern Switzerland
研究点 (2)
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