Clinical trial NCT05453643: EEG Analysis for the Objective Assessment of Drowsiness
Official title: EEG Analysis for the Objective Assessment of Secondary Hypersomnolence in Order to Limit the Accidental Risk
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Deprivation
Keywords: Sleep deprivation
Secondary hypersomnolence
Objective Sleepiness
Subjective Sleepiness
Cognitive performance
Driving
Lead sponsor: Physip S.A
Sponsor class: INDUSTRY
Collaborators: name: University of Bordeaux
name: National Research Agency, France
First posted: 2022-07-12
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: Chronotype and general tendency to daydream in daily life will be evaluated at the inclusion visit. Healthy volunteers will be placed in sleep deprivation patterns that will modify the level of secondary hypersomnolence. These patterns correspond to sleep deprivation caused by work schedules usually observed: shift work (SDP1) or night on-call (SDP2). shift work will be simulated by total sleep deprivation for 24 hours (comparable to the first day of a night worker) followed by early morning sleep, and an extended 17 hours wakefulness (comparable to second day of night shift). Secondary hypersomnolence will be assessed throughout prolonged awakenings (24 hours + 17 hours). The night on-call will be simulated by two half-hour awakenings during the nocturnal sleep. Hypersomnolence will be measured within 17 hours of wakefulness following this sleep fragmentation. The sleep history (quantity and quality of sleep) will be evaluated by actigraphy + ambulatory polysomnography (1 day before the experiment) and 2 polysomnographies in the laboratory during the experiment. Polysomnography recordings will be visually and automatically analyzed by the ASEEGA algorithm. Ambulatory recordings are automatically analyzed by ASEEGA. Throughout these sleep deprivation patterns, electrophysiological variables (EEG, EOG and EMG) will be continuously recorded in order to identify objective drowsiness states determined visually using the OSS or automatically by the MEEGAWAKE algorithm. Subjective sleepiness scale, Mind wandering scale, maintenance of wakefulness tests (MWT, electrophysiological test) and cognitive tests will be repeated, every 4hr, throughout the sleep deprivation patterns in order to determine abilities to stay awake, driving performance, sustained and selective attention, vigilance.

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 \<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 outcomes:
measure: Change in Objective Sleepiness Scale (OSS) during extended wakefulness
timeFrame: Once every 4 hours during SDP1 and SDP2 wakefulness
Secondary outcomes:
measure: Change in Karolinska sleepiness scale (KSS) during extended wakefulness
timeFrame: 12 assessments every 4 hours during SDP1 and SDP2 wakefulness
measure: Change in sleep onset mesured by Maintenance of Wakefulness Test (MWT) during extended wakefulness
timeFrame: Once every 4 hours during SDP1 and SDP2 wakefulness
measure: Change in number of inappropriate line crossings (driving performance) during extended wakefulness
timeFrame: Once every 4 hours during SDP1 and SDP2 wakefulness
measure: Change in Standard deviation of the lateral position of the car (driving performance) during extended wakefulness
timeFrame: Once every 4 hours during SDP1 and SDP2 wakefulness
measure: Change Sustained and selective attention during extended wakefulness
timeFrame: Once every 4 hours during SDP1 and SDP2 wakefulness
measure: Change in Vigilance during extended wakefulness
timeFrame: Once every 4 hours during SDP1 and SDP2 wakefulness
measure: Change in Simple reaction time test (PVT) during extended wakefulness
timeFrame: 1 time every 4 hours during SDP1 and SDP2 wakefulness
measure: Change in conscious experience during extended wakefulness
timeFrame: 5 assessments every 4 hours during SDP1 and SDP2 wakefulness
measure: Munich Chorotype Questionnaire
timeFrame: Once time during inclusion. Visit V0
measure: Horne and Ostberg morning/evening questionnaire (MEQ)
timeFrame: Once time during inclusion. Visit V0
measure: Daydreaming frequency scale
timeFrame: Once time during inclusion. Visit V0
measure: Total sleep time (PSG)
timeFrame: 2 times before SDP1 and SDP2
measure: Sleep onset latency (PSG)
timeFrame: 2 times before SDP1 and SDP2
measure: Sleep efficiency (PSG)
timeFrame: 2 times before SDP1 and SDP2
measure: Amount of sleep stages (PSG)
timeFrame: 2 times before SDP1 and SDP2
measure: Wake after sleep onset (PSG)
timeFrame: 2 times before SDP1 and SDP2
measure: Total sleep time (actigraphy)
timeFrame: 2 times before SDP1 and SDP2
measure: Sleep onset latency (actigraphy)
timeFrame: 2 times before SDP1 and SDP2
measure: Sleep efficiency (actigraphy)
timeFrame: 2 times before SDP1 and SDP2
measure: Wake after sleep onset (actigraphy)
timeFrame: 2 times before SDP1 and SDP2
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Jean-Arthur Micoulaud-Franchi, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: