Exploring Biological Markers of Driver Fatigue for Enhanced Road Safety

NCT07089342 | Completed DMC

• 1 other identifier: EC-2025-141
• Study Type: observational
• Target: 511
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the effectiveness of biological markers in detecting fatigue/sleepiness in a sample of the general driving population in Belgium. The link between the collected biomarkers (oral fluid sample), observed signs of sleepiness in the driver and self-reported driver variables will be analysed. The analysis of the biological samples aims to measure endogenous metabolite levels that are possibly indicative for sleepiness of the donor driver. The respective metabolites will be chosen based on the results of a preceding clinical study (https://clinicaltrials.gov/study/NCT05585515). The objective of this study is to verify and validate the proposed metabolites as biomarkers for driver sleepiness in road traffic.

Conditions

Drowsiness; Sleepiness; Fatigue

Keywords

Fatigue; Drowsy driving; Sleepiness; Road Safety

Outcome Measures

Primary Outcomes (1)

• Changes in metabolite concentrations in oral fluid quantified by liquid chromatography with mass spectrometry

  Investigators will collect oral fluid samples for quantification of all detectable metabolites. Investigators will analyze which metabolite concentration values undergo significant changes with regard to sleep/wake history and demographical data of the donor.

  Baseline: One collection time point after enrollment

Secondary Outcomes (4)

• Subjective sleepiness

  Baseline: One time point after enrollment

• Behavioral markers of drowsy driving: Shivering

  Baseline: One time point after enrollment

• Behavioral markers of drowsy driving: Reaction

  Baseline: One time point after enrollment

• Behavioral markers of drowsy driving: Gait

  Baseline: One time point after enrollment

Study Arms (1)

Road traffic population

People randomly stopped by police in public road traffic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Drivers (all vehicle types, aged 18 or older) voluntarily participating after being randomly stopped during roadside police checks in Belgium

You may qualify if:

• drivers randomly stopped by the police

You may not qualify if:

• refusal to sign informed consent

Sponsors & Collaborators

• Vias Institute Brussel: collaborator
• University of Zurich: lead
• Nationaal Instituut voor Criminalistiek en Criminologie Brussel: collaborator

Study Sites (1)

Vias institute

Brussels, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

oral fluid/saliva

MeSH Terms

Conditions

Sleepiness; Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 28, 2025
• Study Start: August 29, 2025
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

BE (1)