Department of Forensic Pharmacology and Toxicology, Zurich Institute of Forensic Medicine, University of Zurich, Zurich, Switzerland.
Department of Traffic Medicine, Zurich Institute of Forensic Medicine, University of Zurich, Zurich, Switzerland.
Trials. 2023 Feb 21;24(1):131. doi: 10.1186/s13063-023-07154-x.
Too little sleep and the consequences thereof are a heavy burden in modern societies. In contrast to alcohol or illicit drug use, there are no quick roadside or workplace tests for objective biomarkers for sleepiness. We hypothesize that changes in physiological functions (such as sleep-wake regulation) are reflected in changes of endogenous metabolism and should therefore be detectable as a change in metabolic profiles. This study will allow for creating a reliable and objective panel of candidate biomarkers being indicative for sleepiness and its behavioral outcomes.
This is a monocentric, controlled, randomized, crossover, clinical study to detect potential biomarkers. Each of the anticipated 24 participants will be allocated in randomized order to each of the three study arms (control, sleep restriction, and sleep deprivation). These only differ in the amount of hours slept per night. In the control condition, participants will adhere to a 16/8 h wake/sleep regime. In both sleep restriction and sleep deprivation conditions, participants will accumulate a total sleep deficit of 8 h, achieved by different wake/sleep regimes that simulate real-life scenarios. The primary outcome is changes in the metabolic profile (i.e., metabolome) in oral fluid. Secondary outcome measures will include driving performance, psychomotor vigilance test, d2 Test of Attention, visual attention test, subjective (situational) sleepiness, electroencephalographic changes, behavioral markers of sleepiness, changes in metabolite concentrations in exhaled breath and finger sweat, and correlation of metabolic changes among biological matrices.
This is the first trial of its kind that investigates complete metabolic profiles combined with performance monitoring in humans over a multi-day period involving different sleep-wake schedules. Hereby, we aim to establish a candidate biomarker panel being indicative for sleepiness and its behavioral outcomes. To date, there are no robust and easily accessible biomarkers for the detection of sleepiness, even though the vast damage on society is well known. Thus, our findings will be of high value for many related disciplines.
ClinicalTrials.gov Identifier NCT05585515, released on 18.10.2022; Swiss National Clinical Trial Portal SNCTP000005089, registered on 12 August 2022.
睡眠不足及其后果是现代社会的沉重负担。与酒精或非法药物使用不同，目前还没有用于检测困倦的客观生物标志物的快速路边或工作场所测试。我们假设生理功能的变化（如睡眠-觉醒调节）反映在内源性代谢的变化中，因此应该可以作为代谢谱变化的检测。本研究将有助于创建一个可靠和客观的候选生物标志物面板，用于指示困倦及其行为结果。
这是一项单中心、对照、随机、交叉、临床试验，旨在检测潜在的生物标志物。预计的 24 名参与者中的每一位将按照随机顺序分配到三个研究组（对照组、睡眠限制组和睡眠剥夺组）中的每一组。这些组仅在每晚睡眠时间上有所不同。在对照组中，参与者将遵循 16/8 小时的清醒/睡眠时间表。在睡眠限制和睡眠剥夺条件下，参与者将通过模拟现实生活场景的不同清醒/睡眠时间表来累计 8 小时的总睡眠不足。主要结局是口腔液代谢谱（即代谢组）的变化。次要结局指标将包括驾驶表现、精神运动警觉测试、d2 注意力测试、视觉注意力测试、主观（情境）困倦、脑电图变化、困倦的行为标志物、呼气和手指汗液中代谢物浓度的变化，以及生物基质之间代谢变化的相关性。
这是第一项在多日期间涉及不同睡眠-觉醒时间表的人类中结合性能监测研究完整代谢谱的试验。通过该研究，我们旨在建立一个指示困倦及其行为结果的候选生物标志物面板。迄今为止，尽管社会所遭受的巨大损失众所周知，但仍没有用于检测困倦的可靠且易于获取的生物标志物。因此，我们的研究结果将对许多相关学科具有很高的价值。
ClinicalTrials.gov 标识符 NCT05585515，于 2022 年 10 月 18 日发布；瑞士国家临床试验门户 SNCTP000005089，于 2022 年 8 月 12 日注册。
