NCT03692962已完成不适用
Linking the Change in Decision-making After Sleep Restriction to the Restorative Function of Sleep
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- risk-premium
研究概览
简要总结
The aim of this project is to investigate whether enhancing sleep intensity locally in the prefrontal cortex (PFC) can counteract a deterioration of cognitive control and therefore the previously described increase in risk seeking during chronic sleep restriction. To this end, a controlled, counter-balanced study, consisting of two weeks of sleep restriction will be performed. During one of the sleep restriction weeks, sleep intensity in the PFC will be non-invasively enhanced by acoustic stimulation of slow waves during sleep.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 18-21 years or 26-30 years,
- •Right-handedness,
- •Good general health,
- •Good understanding of German language (as all information is provided in German)
- •Signed Informed Consent after being informed.
排除标准
- •Contraindications on ethical grounds,
- •Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc),
- •Known or suspected non-compliance, drug or alcohol abuse (> 5dl wine/ >1l beer daily),
- •Regular medication intake,
- •Enrolment into a clinical trial within last 4 weeks,
- •Diseases or lesions of the nervous system (acute or residual included neurological and psychiatric diseases),
- •Sleep disorders (e.g. Insomnia, sleep apnoea, restless leg syndrome, narcolepsy, etc.),
- •Sleep complaints in general or excessive daytime sleepiness (Pittsburgh Sleep Quality Index > 5; Epworth Sleepiness Scale ≥ 11),
- •Irregular sleep-wake rhythm (e.g. shift working),
- •Long (> 10 hours per night) or short sleepers (< 7 hours per night),
- •Sleep efficiency < 80% in screening night,
- •Travelling with time lag less than 1 month ago (or planning to do so within 1 month prior to or during the study),
- •> 5 drinks or food items containing caffeine per day,
- •> 5 cigarettes per day,
- •Body Mass Index < 19 or > 30 kg/m2,
- •Skin allergy or very sensitive skin
- •Student of one of the following subjects: Mathematics, Physics, Computer Science, Economics, or Psychology (since students of these subjects have profound knowledge of probability calculations, which could interfere with our measurements in decision-making).
- •Red-Green Colour-Blindness (as the Risk Task requires the distinction between red and green),
- •History of claustrophobia,
- •Known hearing disorder (as acoustic stimuli will be applied during sleep),
- •Magnetic Resonance (MR) contraindication (such as pacemaker, implanted pumps, shrapnel, etc.; full MR Screening form will be filled out).
结局指标
主要结局
risk-premium
时间窗: comparison of change from baseline after 7 nights of sleep restriction with acoustic stimulation to change from baseline after 7 nights of sleep restriction without acoustic stimulation
risk-preference (i.e. risk premium assessed with the risk Task as described in Maric et al. 2017 Ann Neurol) after chronic sleep restriction with and without acoustic Stimulation will be quantified by the risk-premium derived from the choices made in the risk-task as described in Maric et al. 2017 Ann Neurol.
次要结局
- confidence(before to after 7 nights of sleep restriction with and without acoustic stimulation)
- high-density electroencephalography (hdEEG) marker of sleep pressure(assessed during first and last sleep restriction nights in comparison to baseline values)
- brain metabolites(before to after 7 nights of sleep restriction with and without acoustic stimulation)
- impulsivity(before to after 7 nights of sleep restriction with and without acoustic stimulation)
- Effort in inhibitory control performance(before to after 7 nights of sleep restriction with and without acoustic stimulation)
- vigilance measures(before to after 7 nights of sleep restriction with and without acoustic stimulation)
- overconfidence(before to after 7 nights of sleep restriction with and without acoustic stimulation)
- Ocular inhibitory control performance(before to after 7 nights of sleep restriction with and without acoustic stimulation)
- Excessive daytime sleepiness(before to after 7 nights of sleep restriction with and without acoustic stimulation)
- deception willingness(before to after 7 nights of sleep restriction with and without acoustic stimulation)
- Motor inhibitory control performance(before to after 7 nights of sleep restriction with and without acoustic stimulation)
研究者
Christian Baumann
Prof. Dr. med.
University of Zurich
研究点 (2)
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