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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Diagnostic test, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
France
CHU de Bordeaux
RECRUITING
Bordeaux
CHU de Montpellier
RECRUITING
Montpellier
APHP - Hôtel-Dieu
RECRUITING
Paris
APHP - la Pitié-Salpêtrière
RECRUITING
Paris
Contact Information
Primary
Julien COELHO, Dr
julien.coelho@chu-bordeaux.fr
05 57 82 08 95
Backup
Nathalie HEYVANG
nathalie.heyvang@chu-bordeaux.fr
05 57 82 08 95
Time Frame
Start Date: 2025-11-13
Estimated Completion Date: 2027-08
Participants
Target number of participants: 100
Treatments
Experimental: 1a
Patient with obstructive sleep apnea (OSA) before/without treatment for OSA
Experimental: 1b
Patient with obstructive sleep apnea (OSA) treated for OSA
Experimental: 2
Participants with type 1 narcolepsy
Active_comparator: 3
Healthy volunteers
Related Therapeutic Areas
Sponsors
Collaborators: Société Française de Recherche et Médecine du Sommeil (S.F.R.M.S)
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov