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| ID | Type | Description | Link |
|---|---|---|---|
| SNCTP000005089 | Registry Identifier | Swiss National Clinical Trials Portal |
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| Name | Class |
|---|---|
| Fonds für Verkehrssicherheit FVS | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 16/8 hours wake/sleep regime for 3 consecutive days at home and for consecutive 2 days in sleep laboratory | |
| Sleep restriction | Experimental | 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 |
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| Sleep deprivation | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep deprivation | Behavioral | Total sleep deficit of consecutive 8 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in metabolite concentrations in oral fluid quantified by liquid chromatography with mass spectrometry | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Driving performance | Investigators will gather driving simulation results via Standardized Application for Fitness to Drive Evaluations (S.A.F.E. scale), and analyze their changes after sleep deficit in comparison to control condition. This scale has a range from 0 (best) to 10 (worst) in full steps. | morning after experimental night (10am) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristina Keller, Dr | University of Zurich, Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Sleep Laboratory, University of Zurich | Zurich | Canton of Zurich | 8057 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36810100 | Derived | Scholz M, Lakaemper S, Keller K, Dobay A, Steuer AE, Landolt HP, Kraemer T. Metabolomics-based Sleepiness Markers for Risk Prevention and Traffic Safety (ME-SMART): a monocentric, controlled, randomized, crossover trial. Trials. 2023 Feb 21;24(1):131. doi: 10.1186/s13063-023-07154-x. |
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Results will be published in peer-reviewed journals. Anonymized raw data will be made available upon request.
starting after publication
upon request via e-mail
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| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| D000077260 | Sleepiness |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| Sleep restriction |
| Behavioral |
Total sleep deficit of cumulative 8 hours |
|
| Psychomotor Vigilance Test |
The Psychomotor Vigilance Test is a gold standard reaction time test to assess vigilance and sustained 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) |
| d2 Test of Attention | The d2 Test of Attention is a paper and pencil test to assess selective and sustained attention and visual scanning speed. | 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 | The visual attention test is a virtual reality glasses test to assess visual skills in a complex visual environment. | 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 situational sleepiness | Participants will complete the Karolinska Sleepiness Scale questionnaire. | 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 sleepiness | Participants will complete the Stanford Sleepiness Scale questionnaire. | 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 | Investigators will analyze changes in sleep and wake electroencephalographic patterns of participants by calculating sleep scores according to American Academy of Sleep Medicine (AASM) scoring manual. | During scheduled sleep, driving simulation test (10am), and at two time points during scheduled wakefulness (12pm, 7pm) |
| Behavioral markers of drowsy driving | Investigators will examine participants after driving simulation test for behavioral abnormalities concerning orientation, coordination, speech, mood, appearance, reaction, and pupillary light reflex. | Once per study arm after driving simulation test (11am) |
| Changes in metabolite concentrations in exhaled breath quantified by liquid chromatography with mass spectrometry | Investigators will collect exhaled breath 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 secondary candidate biomarkers. | 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 | Investigators will collect finger sweat 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 secondary candidate biomarkers. | 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 | Investigators will compare metabolite concentrations in non-invasive matrices (oral fluid, finger sweat, exhaled breath, and dried blood spots) and compare those with blood sample. | immediately after driving simulation test (11am) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |