Decision-making After Sleep Restriction
追踪信息 | |||
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首次提交日期 ICMJE | June 4, 2018 | ||
首次发布日期e ICMJE | October 2, 2018 | ||
最后更新发布日期 | October 2, 2018 | ||
预计研究开始日期 ICMJE | September 1, 2018 | ||
预计主要完成日期 | September 2020 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
risk-premium[ Time Frame: 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. |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Decision-making After Sleep Restriction | ||
正式标题 ICMJE | Linking the Change in Decision-making After Sleep Restriction to the Restorative Function of Sleep | ||
简要概况 | 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. |
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详细说明 | |||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Crossover Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Basic Science |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Recruiting | ||
预计入组 ICMJE |
28 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | September 2021 | ||
预计主要完成日期 | September 2020 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - 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. Exclusion Criteria: - 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). | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:30 Years | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | Switzerland | ||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | Christian Baumann,University of Zurich | ||
研究赞助商 ICMJE | Christian Baumann | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | University of Zurich | ||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |