Exploring Biological Markers of Driver Fatigue for Enhanced Road Safety

NCT ID: NCT07089342

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2025-12-31

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.

Detailed Description

Researchers from NICC (National Institute of Criminalistics and Criminology) and VIAS will collect (1) saliva samples (Salivette with neutral swab allowing use by not-medically trained personnel; this sampling method is also used by the Belgian police in scope of the drugs in traffic legislation since 2019), (2) self-reported driver data (survey) and (3) observed driver data (form filled in by researchers) from drivers that were stopped on the road in scope of routine police checks. The collaboration with the police is because police can stop drivers randomly on-road while researchers cannot. After the police check, a researcher will ask if the driver wants to participate in a study on driver fatigue which is entirely independent from the police check. Voluntary drivers sign an informed consent form.

The collected saliva samples will be entirely separate from any sample obtained during the police checks. During data collection, the saliva sample, driver survey and observation form will each get a unique identification code to link the data. Afterwards, the researchers will work with this anonymised number and the data cannot be traced back to the participant.

All anonymised samples/data will temporarily be stored at NICC (Dept. Toxicology) and then be sent to the University of Zurich for analysis. The analysis of the saliva samples aims to measure endogenous metabolite levels that are possibly indicative for sleepiness of the donor. The correlation of the biomarker levels with observed/reported driver data will be measured. In specific cases the co-existence of drugs/medication in the saliva samples may also be tested: when the donor reported the consumption of the respective substance in the driver survey, as a confirmatory analysis, and (2) when the researchers believe the co-consumption of drugs/medication may interfere with the primary analysis. All anonymised samples will be stored at the University of Zurich for a maximum of 10 years and then be destroyed.

Conditions

Drowsiness; Sleepiness; Fatigue

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Road traffic population

People randomly stopped by police in public road traffic

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• drivers randomly stopped by the police

Exclusion Criteria

• refusal to sign informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vias Institute Brussel

UNKNOWN

Sponsor Role: collaborator

Nationaal Instituut voor Criminalistiek en Criminologie Brussel

UNKNOWN

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Vias institute

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Sofie Boets

Role: CONTACT

sofie.boets@vias.be

+32 2 244 14 12

Other Identifiers

EC-2025-141

Identifier Type: OTHER

Identifier Source: secondary_id

EC-2025-141

Identifier Type: -

Identifier Source: org_study_id