Clinical Trials Directory

Trials / Completed

CompletedNCT05585515

Metabolomics-based Sleepiness Markers

Study of Identification of Metabolomics-based Sleepiness Markers for Risk Prevention and Traffic Safety

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
29 (actual)
Sponsor
University of Zurich · Academic / Other
Sex
Male
Age
20 Years – 35 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSleep deprivationTotal sleep deficit of consecutive 8 hours
BEHAVIORALSleep restrictionTotal sleep deficit of cumulative 8 hours

Timeline

Start date
2022-11-01
Primary completion
2023-05-18
Completion
2023-05-18
First posted
2022-10-18
Last updated
2023-06-02

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT05585515. Inclusion in this directory is not an endorsement.