Enhancement of Sleep Slow Wave Activity Using Wearable Auditory Stimulation Devices and Its Consequences on Daytime Functioning: a Randomized, Counter-balanced Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Sleep quality
研究概览
简要总结
Sleep, specifically deep sleep, plays a central role in healthy brain function, cardio-vascular processes, mood and quality of life. Auditory stimulation during one night of sleep has previously been shown to improve deep sleep and along with memory formation in both young and older adults. Yet, it remains unclear whether long-term auditory stimulation considerably improves sleep quality over longer time periods and how it affects daytime functioning such as cognition, mood, quality of life and peripheral functions (e.g. cardio-vascular). Due to the importance of deep sleep for brain and body and the presence of many conditions that involve reduced deep sleep (e.g. ageing) assessing the beneficial impact of long-term sleep enhancement and its consequences is of central interest.This study will assess the effect of auditory stimulation over two weeks (interleaved with a two weeks washout period) in a cohort of healthy young and older adults using portable recording and stimulation devices.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed Consent as documented by signature
- •For women: Hormonal contraception, if menstrual cycle is still present or has been present less than a year ago
- •Good general health status
- •Stable home situation (e.g. long-term place to live) that allows for reliable application of intervention for the duration of the study
- •Male and Female subjects 18-35 years of age or 60-84 years of age
- •German speaking
排除标准
- •Women who are pregnant or breast feeding,
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Intake of sleep altering medication
- •Inability to follow the procedures of the study, e.g. due to language problems, cognitive deficits
- •Participation in another study with investigational drug within the 30 days preceding and during the present study,
- •Presence or history of diagnosed psychiatric/neurologic disorder/lesion of the central nervous system (CNS),
- •Diagnosed internal disease,
- •Presence of sleep disorders,
- •Shift-work (work during the night) or situations that require several awakenings during the night (e.g. newborn)
- •Travelling more than 2 time zones in the last month before intervention starts or during intervention (study start will be shifted accordingly)
- •Hearing disability/ hearing aid
- •Skin disorders/problems in face region that will worsen with /not allow adhesive electrode application
- •Nicotine/Cannabis use
- •High caffeine consumption (> 5 servings/day; including coffee, energy drink)
结局指标
主要结局
Sleep quality
时间窗: From baseline period to study completion, assessed up to 2 months
Objective information about sleep macro- and microstructure will be assessed including measures like sleep architecture, amount of slow wave activity (SWA), amount of spindles, awakenings during sleep, and sleep fragmentation. In addition, subjective sleep quality will be obtained by questionnaires every morning over the intervention period. These measures will show whether auditory stimulation enhanced overall sleep quality compared to sham.
次要结局
- Daily functioning - Mood(From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks)
- Daily functioning - Vigilance(From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks)
- Physiological parameters - Physical activity(Through study completion, approximately 2 months)
- Daily functioning - Quality of life(From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks)
- Daily functioning - Cognition(From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks)
- Physiological parameters - Cardiovascular(From baseline period to study completion, assessed up to 2 months)