Study of Identification of Metabolomics-based Sleepiness Markers for Risk Prevention and Traffic Safety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Changes in metabolite concentrations in oral fluid quantified by liquid chromatography with mass spectrometry
研究概览
简要总结
Estimating that people sleep on average up to two hours less over the last decades, sleepiness and fatigue need to be considered as significant societal problems of the modern world. Jurisdiction is precise on how to deal with overtired offenders since they were not allowed to use machines or vehicles in the first place, similar to drunk individuals or consumers of illicit drugs. In contrast to alcohol or illicit drug use, however, there are no quick roadside or workplace tests as objective (analytical) biomarkers for sleepiness.
Investigators hypothesize that increasing sleep drive or impaired wakefulness can be assessed by qualitative or quantitative fluctuations of certain metabolites in biological specimens, e.g., accumulation or decrease of endogenous substances related to sleep debt. Thus, this sleep study provides the necessary biological samples of either sleep-deprived, sleep-restricted, or control subjects, which are then analysed for appropriate metabolite biomarkers utilizing an untargeted metabolomics approach. In addition to established impairment tests, a state of the art driving simulator will be employed to objectively measure driving performance under all study conditions. Participants will also rate their subjective sleepiness using validated questionnaires.
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
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •understanding and spoken command of German language
- •good health condition
- •Body Mass Index between 18.5-24.9 kg/m2
- •habitual average sleep duration between 7-9 hours / night
- •habitual consumption of 3 or fewer caffeinated beverages / day
- •habitual consumption of 5 or fewer alcoholic beverages / week
- •good sleep quality: Pittsburgh Sleep Quality Index score ≤ 5
- •reasonable oral hygiene (≥1 tooth brushing / day)
- •normal or corrected-to-normal vision
- •car driving license holder since at least 2 years (obtained in a country with right hand traffic) and regular driver (≥ 1 per week)
排除标准
- •two or more time zone crossings in the last 3 months
- •habitual napper
- •history or presence of neurological disorder, psychiatric disorder, cardiovascular disorder, dental disorder or any disorder that could pose a risk in participating or that could possibly influence study measurements
- •history or presence of a sleep disorder (screening night)
- •use of illicit drugs (urinary drug screening)
- •use of current medication (urinary drug screening) known to influence study measurements
- •extreme chronotype (reduced Morningness-Eveningness-Questionnaire score ≤7 or ≥22)
- •current smoker
- •habitual use of energy drinks (>1 / week)
- •severe skin allergies or hypersensitivities
- •food allergies
- •hospital stay in past 6 months
- •shift worker, night worker
- •recent past (last 3 months) or present Covid-19 infection
- •fainting at the sight of blood or needles
- •participation in a clinical study less than 30 days ago or is currently participating in other clinical studies
- •simulator sickness syndrome
- •refusal to sign informed consent
研究组 & 干预措施
Control
16/8 hours wake/sleep regime for 3 consecutive days at home and for consecutive 2 days in sleep laboratory
Sleep restriction
18/6 hours wake/sleep regime for 3 consecutive days at home and one day in sleep laboratory, followed by recovery night of 8 hours sleep
干预措施: Sleep restriction (Behavioral)
Sleep deprivation
16/8 hours wake/sleep regime for 3 consecutive days at home, one night of sleep deprivation (24/0 hours) in sleep laboratory, followed by recovery night of 8 hours sleep
干预措施: Sleep deprivation (Behavioral)
结局指标
主要结局
Changes in metabolite concentrations in oral fluid quantified by liquid chromatography with mass spectrometry
时间窗: After arrival at study site (6pm, baseline), repeatedly during scheduled wakefulness (8am, 12pm, 4pm, 7pm, 11pm), and morning after recovery night of 8 hours of sleep (8am)
Investigators will collect oral fluid samples from participants for quantification of all detectable metabolites. Investigators will analyze which metabolite concentration values undergo significant changes during sleep deficit conditions in comparison to control condition and also show effects of recovery sleep. These will serve as candidate biomarkers.
次要结局
- Driving performance(morning after experimental night (10am))
- Psychomotor Vigilance Test(After arrival at study site (6pm, baseline), repeatedly during scheduled wakefulness (8am, 12pm, 4pm, 7pm, 11pm), and morning after recovery night of 8 hours of sleep (8am))
- Subjective situational sleepiness(After arrival at study site (6pm, baseline), repeatedly during scheduled wakefulness (8am, 12pm, 4pm, 7pm, 11pm), and morning after recovery night of 8 hours of sleep (8am))
- d2 Test of Attention(After arrival at study site (6pm, baseline), repeatedly during scheduled wakefulness (8am, 12pm, 4pm, 7pm, 11pm), and morning after recovery night of 8 hours of sleep (8am))
- Visual attention test(After arrival at study site (8pm, baseline), repeatedly during scheduled wakefulness (10am, 2pm, 6pm, 8pm), and morning after recovery night of 8 hours of sleep (8am))
- Subjective sleepiness(After arrival at study site (6pm, baseline), repeatedly during scheduled wakefulness (8am, 12pm, 4pm, 7pm, 11pm), and morning after recovery night of 8 hours of sleep (8am))
- Electroencephalographic changes(During scheduled sleep, driving simulation test (10am), and at two time points during scheduled wakefulness (12pm, 7pm))
- Behavioral markers of drowsy driving(Once per study arm after driving simulation test (11am))
- Changes in metabolite concentrations in exhaled breath quantified by liquid chromatography with mass spectrometry(After arrival at study site (8pm, baseline), repeatedly during scheduled wakefulness (10am, 2pm, 6pm, 8pm, 11pm), and morning after recovery night of 8 hours of sleep (8am))
- Changes in metabolite concentrations in finger sweat quantified by liquid chromatography with mass spectrometry(After arrival at study site (8pm, baseline), repeatedly during scheduled wakefulness (10am, 2pm, 6pm, 8pm, 11pm), and morning after recovery night of 8 hours of sleep (8am))
- Correlation of metabolic changes between blood and non-invasive specimens(immediately after driving simulation test (11am))