Study protocol for evaluating EEG-based predictive model for drowsiness measurement to reduce accident risk in active individuals

Abstract

Voluntary behaviors and socio-economic factors, such as social jetlag and shift work, can lead to insufficient or disrupted sleep, resulting in drowsiness in active individuals. In occupational and driving contexts, drowsiness poses a serious safety risk by impairing alertness, slowing reaction times, and increasing the likelihood of accidents. Developing predictive, automatic and easy to implement tools for drowsiness detection is essential in high-risk environments where sustained vigilance is critical. This study aims to validate a practical and predictive method for assessing drowsiness using automated analysis of a limited number of electroencephalogram (EEG) channels. Designed as single-center, non-randomized, single-group, this study will evaluate drowsiness and cognitive performance in forty healthy volunteers exposed to two sleep deprivation conditions simulating real-world occupational scenarios. The primary outcome will be the Objective Sleepiness Scale (OSS) and its automated analysis, with a focus on its ability to measure objective wakefulness as assessed by the Maintenance of Wakefulness Test (MWT). Secondary outcomes will include multimodal resting-state EEG markers, subjective and objective sleepiness measures, performance on a simulated driving task, attention, executive function and vigilance assessments, as well as sleep quality, sleep quantity, and mind-wandering. The influence of sociodemographic and clinical variables on drowsiness measurement and prediction will also be systematically examined. By validating these novel EEG-based measures, this study aims to lay the groundwork for proactive drowsiness management strategies in occupational, transportation, and clinical settings.

Competing Interest Statement

CB, KS, JC, JL, PS, MB, PP, JAM, JT have declared that no competing interests exist. C Berthomier has ownership/directorship and is an employee of Physip, PB & JM are employees of Physip which owns Aseega and MEEGAWAKE® (sleep analysis software).

Clinical Trial

The study was registered in ClinicalTrials.gov (number NCT05453643)

Funding Statement

Yes

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

National Ethical Committee (consultative committee for the protection of persons participating in biomedical research), CPP sud est V, N° SI RIPH 2G : 22.00521.000045

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

No datasets were generated or analysed during the current study. All relevant deidentified data will be made available upon study completion and results publication.

Comments (0)

No login
gif