Actively Recruiting
Test-retest Reliability of the Maintenance of Wakefulness Test in Participants With Hypersomnolence
Led by University Hospital, Bordeaux · Updated on 2026-03-17
100
Participants Needed
4
Research Sites
89 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Bordeaux
Lead Sponsor
S
Société Française de Recherche et Médecine du Sommeil (S.F.R.M.S)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Test-retest Reliability of the Maintenance of Wakefulness Test in Participants With Hypersomnolence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be affiliated with or a beneficiary of a social security system
- Have given free and informed written consent to participate
- Be a participant suspected of obstructive sleep apnea syndrome without previous diagnosis or treatment and have an Epworth Sleepiness Scale score of 11 or higher
- Be receiving effective and stable treatment for obstructive sleep apnea syndrome for at least 15 days and scheduled for MWT, with age stratification (half under 40 years old, half 40 or older)
- Be receiving effective and stable treatment for narcolepsy type 1 for at least 15 days and scheduled for MWT
- Be a healthy volunteer with an Epworth Sleepiness Scale score less than 11
You will not qualify if you...
- Have comorbid sleep disorders associated with excessive daytime sleepiness (e.g., both OSAS and narcolepsy)
- Have severe conditions that threaten life in the short term
- Have unstable cardiovascular, neurological, psychiatric, respiratory, infectious, endocrine, or systemic disease that may require hospitalization or therapy changes during the study
- Have introduced or changed psychotropic medication dosage in the past year that may affect arousal or MWT results
- Be a healthy volunteer suspected of sleep apnea syndrome (STOP-BANG score 5 or higher) or suspected insomnia disorder (ISI score 22 or higher)
- Be a shift or night worker
- Be pregnant or breastfeeding
- Be under curatorship or guardianship
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
CHU de Bordeaux
Bordeaux, France
Actively Recruiting
2
CHU de Montpellier
Montpellier, France
Actively Recruiting
3
APHP - Hôtel-Dieu
Paris, France
Actively Recruiting
4
APHP - la Pitié-Salpêtrière
Paris, France
Actively Recruiting
Research Team
J
Julien COELHO, Dr
CONTACT
N
Nathalie HEYVANG
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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