EEG Analysis for the Objective Assessment of Drowsiness

NCT05453643 · tracked via the Priya Life Science France tracker

Sponsor

Physip S.A

Phase

Not applicable

Started

2023-03-08

Last updated

2026-09-21

Condition(s) studied

Sleep Deprivation

Investigational drug(s) / intervention(s)

sleep deprivation patterns

sleep deprivation patterns: Sleep deprivation patterns 1 (SDP1) ; total sleep deprivation for 24 hours followed by early morning sleep and an extended 17 hours wakefulness. Sleep deprivation patterns 2 (SDP2) : Sleep interrupted by two half-hour awakenings

Study summary

The objective of this clinical study is to develop solutions for the evaluation and management of drowsiness, based on 2 EEG sensors only, aiming at reducing the risk of accidents related to secondary hypersomnolence (sleepiness induced by sleep restriction or abnormal sleep/wake cycle). This project will allow a better understanding of the determinants of drowsiness and its impact on cognitive performance and the development of methods and models for the evaluation and prediction of cognitive performance deficit related to sleepiness. The secondary hypersomnolence will be objectified by continuous EEG recording and analysed by visual reading according to Objective Sleepiness Scale (OSS) criteria and automatically analyzed using the MEEGAWAKE algorithm (developed by PHYSIP). The level of secondary hypersomnolence will be modified by varying the duration and maintening of prior sleep or the sleep timing. The ability to stay awake will be measured by the maintenance of wakefulness test (MWT). Subjective sleepiness and mind wandering will be measured before and/or after all measurements. Simulated driving task, maintenance of wakefulness tests and several cognitive tasks to measure sustained attention, alertness, selective attention will be performed every 4 hours.

Eligibility

Sex

ALL

Min age

20 Years

Max age

60 Years

Healthy volunteers

Accepted

Inclusion Criteria: * BMI between 18 and 27, * With a score on the PHQ-4 scale less than or equal to 2 for scores A (Anxiety) and D (Depression), * Subjects with no complaints of excessive daytime sleepiness (total ESS score \<11), * Non-professional drivers, * Subjects who have held their driving license for at least one year, * Subjects affiliated to a social security scheme, * Subjects able to understand the study, * Subjects available to come to the 3 visits required by the study, * Free, informed and written consent signed Exclusion Criteria: * Pathologies that can induce excessive daytime sleepiness: untreated narcolepsy or idiopathic hypersomnia, untreated restless legs syndrome, untreated periodic leg movement syndrome, * Chronic insomnia disorder, * Excessive alcohol consumption (\> 2 glasses per day) during the last 6 months, * Excessive consumption of coffee, tea or cola-type caffeinated beverages (\> 5 cups/day), * Severe pathologies involving the vital prognosis in the short term, * Uncontrolled endocrine pathologies (dysthyroidism, diabetes), * All progressive cardiac pathologies, treated or untreated, * All progressive neurological conditions treated or not (brain tumor, epilepsy, migraine, stroke, sclerosis, myoclonus, chorea, neuropathy, muscular dystrophies, myotonic dystrophy, etc.), * Substance dependence, * Shift workers or night workers who have performed on-call or on-call duty in the last 72 hours, * Patients taking psychotropic drugs (antidepressants, antihistamines), * Long-term treatment with benzodiazepines and z-drugs, * Patients on cardiotropic, * Deprived of liberty by a judicial or administrative decision, * Pregnant or breastfeeding woman, * Subject under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision

Primary outcome measure(s)

Change in Objective Sleepiness Scale (OSS) during extended wakefulness — Once every 4 hours during SDP1 and SDP2 wakefulness
OSS is based on the visual analysis of electrophysiological variables (EEG (C4, O2, C3, P3), 1 vertical EOG and 1 horizontal EOG). Each state of drowsiness (score) corresponds to a specific EEG activity accompanied by well-differentiated blinking and eye movements

Trial sites (1)

Facility	City	Region	Status
CHU bordeaux	Bordeaux	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05453643 on ClinicalTrials.gov ↗ ← All trials in France