Modulation of Sleep Slow Wave Activity Through Acoustic Stimulation and Its Consequences on Cardiovascular Functions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Cardiac autonomic regulation
研究概览
简要总结
Sleep and particularly deep sleep are playing an important role for brain and body health. Poor sleep has been associated with risk factors for cardiovascular disease and moreover, is hypothesized to increased mortality risk of cardiovascular diseases. Yet, the role of specific sleep processes for cardiovascular function remains unclear. Particularly deep sleep, which is manifested by large amplitude, low frequency oscillations is of importance for the restorative functions of sleep. Thus, the modulation of deep sleep by auditory stimulation will be of central interests to assess the cause-effect relationship of specific processes within sleep for cardiovascular regulation.
This study will assess the effects of slow wave modulating auditory stimulation on cardiovasuclar functions in healthy male participants.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Informed Consent
- •Good general health status
- •Male subjects 18-84 years of age
- •Native German speaker or good understanding of German
排除标准
- •Contraindications on ethical grounds,
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Regular medication intake that could pronouncedly affect outcomes of interest (e.g. beta-blocker)
- •Long (> 9.5 hours per night) or short sleepers (< 6.5 hours per night),
- •Smoking (regular smoker, >10 days per year, smoking not allowed during study participation)
- •Participation in another study with investigational drug/therapy/interventions within the 30 days preceding and during the present study (start date adapted accordingly),
- •Diseases or lesions of the nervous system (acute or residual included neurological and psychiatric diseases),
- •Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
- •Pacemaker,
- •Intake of on-label sleep medication,
- •Presence or suspicion of sleep disorders (e.g., insomnia, sleep disordered breathing (apnea), restless legs syndrome). Possibility of apnea might be assessed in the screening night,
- •Body Mass Index < 18 or > 30 kg/m2,
- •Irregular sleep-wake rhythm (e.g. shift working),
- •Bad sleep quality during screening night (e.g. < 75% sleep efficiency in screening night)
- •Significant sleep complaints in general or excessive daytime sleepiness (PSQI > 5; ESS ≥ 11),
- •Travelling more than 2 time zones in the 2 weeks before experimental session starts or during intervention (start of experiment will be adapted to fit with this criteria),
- •Hearing disability/ hearing aid (only an exclusion if in a simple audiometry participants cannot hear intervention tone sound levels),
- •Skin disorders/problems/allergies (face region) that will significantly worsen with electrode application,
- •High caffeine consumption (> 5 servings/day; including coffee and caffeinated energy drinks),
研究组 & 干预措施
Slow waves enhancing acoustic stimulation
During non-rapid eye movement (NREM) sleep, acoustic stimuli will be played to increase slow wave amplitude.
干预措施: Acoustic stimulation (Other)
SHAM: no application of acoustic stimuli
During NREM sleep no acoustic stimuli will be played.
干预措施: SHAM acoustic stimulation (Other)
Slow waves decreasing acoustic stimulation
During NREM sleep acoustic stimuli will be played to decrease/modulate slow waves amplitude in a dose-dependent way (e.g. less pronounced than arm 1).
干预措施: Acoustic stimulation (Other)
结局指标
主要结局
Cardiac autonomic regulation
时间窗: continuously across approximately 8 hours of sleep with and without acoustic stimulation
assessed by heart rate variability derived from electrocardiography
Change in cardiac autonomic regulation
时间窗: Before to after approximately 8 hours of sleep with and without acoustic stimulation
assessed by changes in heart rate variability derived from electrocardiography
Heart rate
时间窗: continuously across approximately 8 hours of sleep with and without acoustic stimulation
measured with electrocardiography
Change in heart rate
时间窗: Before to after approximately 8 hours of sleep with and without acoustic stimulation
measured with electrocardiography
Marker for sleep depth
时间窗: continuously across approximately 8 hours of sleep with and without acoustic stimulation
Slow wave activity assessed with high-density electroencephalography(hdEEG)
次要结局
- Change in vascular functioning(Before and/or after approximately 8 hours of sleep with and without acoustic stimulation)
- Arterial pressure waveform(continuously across approximately 8 hours of sleep with and without acoustic stimulation)
- Change in arterial pressure waveform(Before to after approximately 8 hours of sleep with and without acoustic stimulation)
- Oxyen saturation(continuously across approximately 8 hours of sleep with and without acoustic stimulation)
- Overnight memory consolidation(Before to after approximately 8 hours of sleep with and without acoustic stimulation)
- Changes in vigilance(Before to after approximately 8 hours of sleep with and without acoustic stimulation)
- Changes in muscular fatigue(Before to after approximately 8 hours of sleep with and without acoustic stimulation)
- Changes in bandwidth of of 0.5-30 Hz of high-density electroencephalography (hdEEG)(Before to after approximately 8 hours of sleep with and without acoustic stimulation)
- Hypnogram(Over approximately 8 hours of sleep with and without acoustic stimulation)
研究者
Caroline Lustenberger
Principal Investigator
Swiss Federal Institute of Technology