背景:睡眠不足及其后果是现代社会的沉重负担。与酗酒或非法吸毒相反,没有针对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(例如睡眠-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的变化来检测。这项研究将允许创建一个可靠和客观的候选生物标志物组,指示嗜睡及其行为结果。
方法:这是一个单中心,控制,随机化,交叉,临床研究以检测潜在的生物标志物。预期的24名参与者中的每一个将按随机顺序分配到三个研究组中的每一个(对照,睡眠限制,和睡眠剥夺)。这些仅在每晚睡觉的时间上有所不同。在控制条件下,参与者将坚持16/8小时唤醒/睡眠制度。在睡眠限制和睡眠不足的情况下,参与者将累积8h的总睡眠不足,通过模拟现实生活场景的不同唤醒/睡眠机制来实现。主要结果是代谢谱的变化(即,代谢组)在口服液中。次要结果衡量标准将包括驾驶绩效,精神运动警觉测验,d2注意力测试,视觉注意力测试,主观(情境)嗜睡,脑电图改变,嗜睡的行为标志,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。
结论:这是同类试验中的第一个,在涉及不同睡眠-觉醒时间表的多天时间内,研究人类完整的代谢谱与表现监测相结合。特此,我们的目标是建立一个候选生物标志物组,以指示嗜睡及其行为结局.迄今为止,没有可靠且易于获取的生物标志物来检测嗜睡,尽管对社会的巨大破坏是众所周知的。因此,我们的发现将对许多相关学科具有很高的价值。
背景: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。
BACKGROUND: 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.
METHODS: 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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov Identifier NCT05585515, released on 18.10.2022; Swiss National Clinical
Trial Portal SNCTP000005089, registered on 12 August 2022.