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

NCT07120061 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-17

No results posted yet for this study

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.

Conditions

  • Disorders of Excessive Somnolence

Interventions

DIAGNOSTIC_TEST

First MWT

MWT during the first visit of the protocol

DIAGNOSTIC_TEST

second MWT

MWT during the second visit of the protocol

DEVICE

actimetry

In order to monitor compliance with the guidelines prior to each MWT, namely good sleep hygiene in the 14 days preceding the MWT, and in accordance with the recommendations of the AASM, an actimeter will be worn by the participant.

Sponsors & Collaborators

  • Société Française de Recherche et Médecine du Sommeil (S.F.R.M.S)

    collaborator UNKNOWN

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Jean-Arthur MICOULAUD-FRANCHI, Pr · University Hospital, Bordeaux

  • Julien COELHO, Dr · University Hospital, Bordeaux

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-13
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07120061 on ClinicalTrials.gov