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EEG Analysis for the Objective Assessment of Drowsiness

France40 participantsStarted 2022-11

Plain-language 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.

Who can participate

Age range20 Years – 60 Years

SexALL

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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 (antidepressan…

What they're measuring

Change in Objective Sleepiness Scale (OSS) during extended wakefulness

Timeframe: Once every 4 hours during SDP1 and SDP2 wakefulness

Trial details

NCT IDNCT05453643

SponsorPhysip S.A

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09

Contact for this trial

Jean-Arthur MICOULAUD-FRANCHI, MD/PhD

05 57 82 01 73 jean-arthur.micoulaud-franchi@chu-bordeaux.fr