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Test-retest Reliability of the Maintenance of Wakefulness Test in Participants With Hypersomnolence

RecruitingNAAges 18 Years - 65 YearsAllUniversity Hospital, Bordeaux
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In plain words

What the trial is, and whether it could suit you

This study will provide the first measurement of the test-retest reliability of the Maintenance of Wakefulness Test (MWT) with a prospective multicenter design. A high level of reliability will reinforce the place of the MWT as an essential tool to respond to the medical and legal worldwide issue of the driving risk related to hypersomnolence. This would legitimize its place as a medico-legal examination in France and promote its diffusion in other countries. A low level of reliability will call into question the place of the MWT in the management of participants with hypersomnolence. Bordeaux University Hospital is the sponsor of this research. This research will be conducted with the support of Société Française de Recherche en Médecine du Sommeil.

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📋 Eligibility rules (as published)
Inclusion Criteria : * Being affiliated or beneficiaries of a social security system. * Having been informed of the study and having given their free and informed consent, written and signed consent to participate to the study Plus one of the following inclusion criteria: * Participant with a suspicion of OSAS without any previous diagnosis or treatment and with Epworth Sleepiness Scale ≥ 11. * Participant with effective and stable treatment for OSAS (defined by apnea-hypopnea index ≥ 15 per hour) since at least 15 days and intended to be explored by a MWT. This group will be stratified on the age (half of patients of this group \< 40 years old and the other half of patients of his group ≥ 40 years old). * Participant with effective and stable treatment for narcolepsy type 1 as defined by the ICSD-3 (cataplexy or lack of orexine) since at least 15 days and intended to be explored by a MWT. * Healthy volunteers with Epworth Sleepiness Scale \< 11. Exclusion Criteria: * Comorbid sleep disorders associated with excessive daytime sleepiness (e.g., OSAS and narcolepsy) * Severe conditions endangering life in the short term * Participant with cardiovascular, neurological, psychiatric, respiratory, infectious, endocrine, or systematic pathology, which is not stabilized and may require hospitalization or a modification of therapy during the duration of the study * Introduction or change in dosage of a psychotropic medication in the previous year which may modify the level of arousal in the previous year and modify the MWT results * Healthy volunteer with suspected SAOS (total score at STOP-BANG≥ 5) or suspected insomnia disorder (total score at ISI≥ 22) * Shift or night workers * Pregnant or breastfeeding woman * Participants under curatorship or guardianship
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What it tests

  • First MWT
  • second MWT
  • actimetry
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Where

4 sites
CHU de Bordeaux
Bordeaux, France
CHU de Montpellier
Montpellier, France
APHP - Hôtel-Dieu
Paris, France
APHP - la Pitié-Salpêtrière
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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