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.
Who can participate
Age range
20 Years – 35 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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 n…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in metabolite concentrations in oral fluid quantified by liquid chromatography with mass spectrometry
Timeframe: 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)