Checking whether the Maintenance of Wakefulness Test gives consistent results for people with hypersomnolence.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Glaucoma and Brain Changes: How Brain Structure and Size See What Glaucoma Is Doing

  This study tests whether glaucoma is linked to broader brain changes by comparing brain MRI and eye health over time in people with glaucoma and matched controls.

  Recruiting University Hospital, Bordeaux · Bordeaux · NCT07802769

• Who’s at high risk after RCC surgery? Real-world clues from French registry

  This study looks at real-world data from French RCC patients who had local or high-risk locally advanced disease to see how they do after surgery and how doctors decide on adjuvant treatment.

  Recruiting University Hospital, Bordeaux · Bordeaux · NCT07753343

• Prediction score for death or lung transplant in emphysema caused by alpha-1 antitrypsin deficiency

  This study tests a new prediction tool to identify people with emphysema due to alpha-1-antitrypsin deficiency who are at high risk of death or needing a lung transplant.

  Recruiting at 4 sites University Hospital, Bordeaux · Bron and 3 other locations · NCT07715617

• Frailty score predicts quality of life after emergency heart surgery in people 75 and older

  This study tests whether a preoperative frailty score can predict quality of life one year after emergency heart surgery in patients aged 75 and up.

  Recruiting University Hospital, Bordeaux · Bordeaux, France · NCT07677319

• Evolution of spinal care practices in Bordeaux

  This study will track how care for spine conditions changes over five years by collecting data from adults treated for spinal issues at a Bordeaux hospital.

  Recruiting University Hospital, Bordeaux · Bordeaux · NCT07627282

• Feeding-jejunostomy nutrition during pre-surgery treatment for esophagus or stomach cancer

  This study tests whether giving nutrition through a jejunostomy tube during pre-surgery (neoadjuvant) treatment helps reduce complications after surgery for malnourished people with esophageal or stomach cancer.

  Recruiting University Hospital, Bordeaux · Pessac · NCT07584577

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.