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Active Not Recruiting
NCT05453643
EEG Analysis for the Objective Assessment of Drowsiness
Conditions: Sleep Deprivation
Sex: All
Ages: 20 Years – 60 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 40
Sponsor: Physip S.A
Location: CHU bordeaux Bordeaux
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 Criteria
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 \ 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
Source: ClinicalTrials.gov (NCT05453643). StuddyBuddy aggregates publicly available trial information.