Checking whether the Maintenance of Wakefulness Test gives consistent results for people with hypersomnolence.
Test-retest Reliability of the Maintenance of Wakefulness Test in Participants With Hypersomnolence
We will test whether two Maintenance of Wakefulness Tests give similar results for people with excessive daytime sleepiness, including those with obstructive sleep apnea, narcolepsy type 1, and healthy volunteers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 4 sites (Bordeaux and 3 other locations) |
| Trial ID | NCT07120061 on ClinicalTrials.gov |
What this trial studies
This multicenter prospective study will measure the test-retest reliability of the Maintenance of Wakefulness Test (MWT) by having participants complete two MWT sessions less than 28 days apart. A factorial design will enroll 50 participants with obstructive sleep apnea (25 untreated and 25 on stable treatment), 25 participants with treated narcolepsy type 1, and 25 healthy volunteers, with actimetry and baseline sleepiness questionnaires collected. The trial aims to quantify day-to-day variability in MWT mean sleep latency under controlled conditions. Results will inform the MWT's role as an objective marker for driving risk and its use in medico-legal fitness-to-drive decisions.
Who should consider this trial
Good fit: Ideal candidates are adults with hypersomnolence: people with suspected untreated OSAS, people on stable OSAS treatment, people on stable treatment for narcolepsy type 1, and healthy volunteers who meet the Epworth Sleepiness Scale criteria.
Not a fit: People with unstable or recently changed treatments, major comorbid medical or psychiatric conditions, or those unable to attend two in-lab visits within 28 days may not benefit from participation.
Why it matters
Potential benefit: If reliable, the MWT could be used more confidently by clinicians and licensing authorities to help determine driving fitness for people with excessive sleepiness.
How similar studies have performed: Prior studies have shown that MWT mean sleep latency relates to driving risk, but there are no prior prospective multicenter data on day-to-day test-retest reliability.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bordeaux and 3 other locations
- CHU de Bordeaux — Bordeaux, France (Recruiting)
- CHU de Montpellier — Montpellier, France (Recruiting)
- APHP - Hôtel-Dieu — Paris, France (Recruiting)
- APHP - la Pitié-Salpêtrière — Paris, France (Recruiting)
Study contacts
- Principal investigator: Jean-Arthur MICOULAUD-FRANCHI, Pr — University Hospital, Bordeaux
- Study coordinator: Julien COELHO, Dr
- Email: julien.coelho@chu-bordeaux.fr
- Phone: 05 57 82 08 95
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.