EEG Analysis for the Objective Assessment of Drowsiness

NCT05453643 | Unknown

• 1 other identifier: MGSF
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Deprivation

Keywords

Sleep deprivation; Secondary hypersomnolence; Objective Sleepiness; Subjective Sleepiness; Cognitive performance; Driving

Outcome Measures

Primary Outcomes (1)

• Change in Objective Sleepiness Scale (OSS) during extended 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

  Once every 4 hours during SDP1 and SDP2 wakefulness

Secondary Outcomes (20)

• Change in Karolinska sleepiness scale (KSS) during extended wakefulness

  12 assessments every 4 hours during SDP1 and SDP2 wakefulness

• Change in sleep onset mesured by Maintenance of Wakefulness Test (MWT) during extended wakefulness

  Once every 4 hours during SDP1 and SDP2 wakefulness

• Change in number of inappropriate line crossings (driving performance) during extended wakefulness

  Once every 4 hours during SDP1 and SDP2 wakefulness

• Change in Standard deviation of the lateral position of the car (driving performance) during extended wakefulness

  Once every 4 hours during SDP1 and SDP2 wakefulness

• Change Sustained and selective attention during extended wakefulness

  Once every 4 hours during SDP1 and SDP2 wakefulness

Study Arms (1)

Sleep deprivation

EXPERIMENTAL

healthy volunteers

Behavioral: sleep deprivation patterns

Interventions

sleep deprivation patterns BEHAVIORAL

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

Sleep deprivation

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Physip S.A: lead
• University of Bordeaux: collaborator
• National Research Agency, France: collaborator

Study Sites (1)

CHU bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Jean-Arthur Micoulaud-Franchi, MD/PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Arthur MICOULAUD-FRANCHI, MD/PhD

CONTACT

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

jacques Taillard, PhD

CONTACT

05 57 82 01 73; jacques.taillard@u-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: July 12, 2022
• Study Start: November 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: October 6, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)