The Role of the Circadian System in Neurological Sleep-wake Disorders: Assessment of Circadian and Homeostatic Sleep-wake Regulation and Vigilance With a Poly-nap Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- EEG slow-wave activity (SWA)
研究概览
简要总结
The aim of this study is to investigate the role of the circadian system in patients with neurologic sleep-wake disorders. Therefore, overnight sleep will be distributed over 30 hours into repetitive sleep-wake cycles (poly-nap protocol), so that sleep episodes occur at different circadian phases. Vigilance, attention, risk behavior as well as sleep onset latency will be observed.
Ambulatory accelerometer recordings gain more and more attention in the diagnostic work-up of sleep disorders, as they allow to also include the everyday rest-activity rhythm before examinations in the sleep laboratory. Advances of novel devices should improve the detection of rest and activity and therefore the estimation of sleep and wake, especially in patients with neurologic sleep-wake disorders exhibiting fragmented sleep. Two types of actimeters will be applied throughout our study protocol to explore better classification of sleep and wake phases and patterns of the rest-activity rhythm.
This study is designed as an observational case-controlled study targeting the disorders of narcolepsy type 1 and idiopathic hypersomnia, and including interventional procedures in the healthy control group (sleep deprivation, sleep restriction) in a counter-balanced design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and Female participants 18 years to 35 years of age
- •Written informed consent by the participant after information about the research project
- •Healthy controls: 7-8 hours of sleep per night
- •Healthy controls: sleep satiation before start of the study
- •Narcolepsy type 1: diagnosis of narcolepsy with cataplexy, drug free during study, proven excessive daytime sleepiness with increased REM (MSLT), clear-cut cataplexy present, undetectable or low cerebrospinal fluid hypocretin levels (if data is available)
- •Idiopathic hypersomnia: diagnosis of idiopathic hypersomnia, drug free during study, proven excessive daytime sleepiness without increased REM (MSLT), increased sleep need (>10h/day) on work-free days shown by 2-week actigraphy
排除标准
- •signs of neurological, psychiatric, or other sleep-wake disorders
- •signs of sleep deprivation
- •shift work and time zone change of more than one hour within one month prior the study start
- •extreme morning and evening types
- •underweight
- •obstructive gastro-intestinal disease or history of gastrointestinal surgery
- •an implanted medical device or a scheduled MRI scan during the experimental period
结局指标
主要结局
EEG slow-wave activity (SWA)
时间窗: Over nap times, up to 80 minutes.
SWA is a marker of homeostatic sleep pressure and will show whether patients with narcolepsy or idiopathic hypersomnia live under different sleep pressure than controls.
Endogenous melatonin
时间窗: Half an hour before and half an hour after a nap during PNP protocol, up to 2 minutes.
Dim light melatonin onset (DLMO) will show whether there is a phase difference between patient groups and between patients and controls. The amplitude of the melatonin profile will show whether there is a dampening of the circadian rhythm or not.
次要结局
- Performance in neurobehavioral tests(One hour before each nap, up to 45mins.)
- EEG event related potentials (ERPs)(One hour before each nap, up to 45minutes.)
研究者
Esther Werth
Head of Sleep Laboratory
University of Zurich