Effects of Synchronised Auditory Stimulations of the Sleep Slow Oscillation on Deep Sleep
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Variation of the amplitude of sleep slow oscillations
研究概览
简要总结
This monocentric, cross-over, randomised, double blind and placebo-controlled study evaluates the effects of auditory stimulations of the sleep slow oscillation on deep sleep quality.
详细描述
Sleep quality impairment has long been identified as a risk factor to develop cardio-vascular, metabolic and more recently neurodegenerative diseases. The slow wave sleep, characterized by slow oscillations, has a major role on memory and hormones releasing. Here, we aim to assess a miniaturized sleep device that would automatically detect and stimulate sleep slow oscillations with sounds to enhance deep sleep quality.
The subjects realize 3 conditions :
- Up condition : Auditory stimulations are delivered in synchrony with the up phase of slow oscillations during N3 sleep stage.
- Random condition : Auditory stimulations are randomly delivered during N3 sleep stage.
- Placebo condition: The device is worn without any auditory stimulations delivered.
The subjects are equipped with a reference polysomnography and the auditory stimulation device during 3 nights and one habituation night prior to them. A wash out period of 6 days between each night will be respected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •healthy subject
- •moderate morningness, intermediate or moderate eveningness chronotype (Horne & Östberg questionnaire)
排除标准
- •sleep disorder according to the ICSD-3 or DSM-5
- •travelling away from more than a time zone in the previous month
- •acute or chronic disorders (cardio-vascular, respiratory, neurologic, psychiatric)
- •night shifts work
- •smoking more than 5 cigarettes per day
- •drinking more than 5 glass of alcohol per week
- •consuming excessive drinks with xanthics (coffee, tea, coke more than 6 cups per day).
- •having a body mass index >30kg.m -2
- •being pregnant
结局指标
主要结局
Variation of the amplitude of sleep slow oscillations
时间窗: 3 days
Amplitude of sleep slow oscillation assessed during N3 sleep stages throughout 3 separate nights. The analysis is based on electroencephalography signal.
次要结局
- Variation of the number of remembered words in declarative memory tasks (word pair task)(3 days)
- Variation of mood assessment measured with the profile of mood scale (POMS)(3 days)
- Variation of mental rotation capacity (mental rotatory task)(3 days)
- Variation of N3 sleep stage duration(3 days)
- Variation of subjective sleepiness measured with the Karolinska sleepiness scale (KSS)(3 days)
- Variation of the number of sleep slow oscillations(3 days)
- Variation of average response time variation and omissions in the Psychomotor vigilance task (PVT)(3 days)
- Variation of salivary cortisol concentration(3 days)
- Variation of salivary testosterone concentration(3 days)