Clinical trial NCT05585515: Metabolomics-based Sleepiness Markers
Official title: Study of Identification of Metabolomics-based Sleepiness Markers for Risk Prevention and Traffic Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Sleepiness
Insufficient Sleep Syndrome
Keywords: metabolomics
sleep
biomarker
impairment
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Fonds für Verkehrssicherheit FVS
First posted: 2022-10-18
Enrollment: 29
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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 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

Primary outcomes:
measure: 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)
Secondary outcomes:
measure: Driving performance
timeFrame: morning after experimental night (10am)
measure: Psychomotor Vigilance Test
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)
measure: d2 Test of Attention
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)
measure: Visual attention test
timeFrame: 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)
measure: Subjective situational sleepiness
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)
measure: Subjective sleepiness
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)
measure: Electroencephalographic changes
timeFrame: During scheduled sleep, driving simulation test (10am), and at two time points during scheduled wakefulness (12pm, 7pm)
measure: Behavioral markers of drowsy driving
timeFrame: Once per study arm after driving simulation test (11am)
measure: Changes in metabolite concentrations in exhaled breath quantified by liquid chromatography with mass spectrometry
timeFrame: 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)
measure: Changes in metabolite concentrations in finger sweat quantified by liquid chromatography with mass spectrometry
timeFrame: 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)
measure: Correlation of metabolic changes between blood and non-invasive specimens
timeFrame: immediately after driving simulation test (11am)
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Human Sleep Laboratory, University of Zurich
state: Zurich
Study officials:
affiliation: University of Zurich, Zurich
name: Kristina Keller, Dr
role: PRINCIPAL_INVESTIGATOR
References: