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

NCT07120061 | Recruiting

• 1 other identifier: CHUBX 2024/88
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Hypersomnolence; Driving risk; Biomarker; Maintenance of Wakefulness; Test-retest reliability

Outcome Measures

Primary Outcomes (1)

• Mean sleep latency of the MWT

  Sleep latency value in the wakefulness maintenance test.

  v2 (up to 90 days after V0)

Secondary Outcomes (17)

• Bordeaux Sleepiness Scale

  at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)

• Chronotype

  at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)

• Sleepiness (1)

  at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)

• Sleepiness (2)

  at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)

• Sleepiness (3)

  at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)

Study Arms (4)

1a

EXPERIMENTAL

Patient with obstructive sleep apnea (OSA) before/without treatment for OSA

Diagnostic Test: First MWT; Diagnostic Test: second MWT; Device: actimetry

1b

EXPERIMENTAL

Patient with obstructive sleep apnea (OSA) treated for OSA

Diagnostic Test: First MWT; Diagnostic Test: second MWT; Device: actimetry

2

EXPERIMENTAL

Participants with type 1 narcolepsy

Diagnostic Test: First MWT; Diagnostic Test: second MWT; Device: actimetry

3

ACTIVE COMPARATOR

Healthy volunteers

Diagnostic Test: First MWT; Diagnostic Test: second MWT; Device: actimetry

Interventions

First MWT DIAGNOSTIC_TEST

MWT during the first visit of the protocol

1a; 1b; 2; 3

second MWT DIAGNOSTIC_TEST

MWT during the second visit of the protocol

1a; 1b; 2; 3

actimetry DEVICE

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.

1a; 1b; 2; 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Société Française de Recherche et Médecine du Sommeil (S.F.R.M.S): collaborator

Study Sites (4)

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

MeSH Terms

Conditions

Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Jean-Arthur MICOULAUD-FRANCHI, Pr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Julien COELHO, Dr

  University Hospital, Bordeaux

  STUDY CHAIR

Central Study Contacts

Julien COELHO, Dr

CONTACT

05 57 82 08 95; julien.coelho@chu-bordeaux.fr

Nathalie HEYVANG

CONTACT

05 57 82 08 95; nathalie.heyvang@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 13, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)