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

Overview

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.

Detailed description

Hypersomnolence is a frequent and disabling symptom that has an impact on an individual's daytime functioning and particularly on driving, increasing the risk of traffic accidents related to sleepiness. Objective markers for assessing hypersomnolence are particularly important to overcome reporting bias since it is listed as a factor of temporary medical incompatibility to obtain or maintain a driving license in several countries, including France. According to the American Academy of Sleep Medicine (AASM), the MWT is the most relevant test for medico-legal assessments of fitness to drive.

Several experimental and epidemiological studies have shown that mean sleep latency at the MWT is a valid biomarker for assessing driving risk. However, there is currently no data on the test-retest reliability of the MWT from one day to the next. This is all the more important given the implications on the driving ability, and the variability associated with good participant compliance (good sleep hygiene the night before the test, absence of stimulation during the test). This study will use a factorial design to allow for stratified analyses with strong power (50 participants with Obstructive sleep apnea syndrome (OSAS), including 25 before/without treatment and 25 after/under treatment, and 25 participants with narcolepsy type 1 ,(after/under treatment) and 25 healthy volunteers. All participants will undergo an inclusion visit (V0) and two MWT (V1 and V2) separated by less than 28 days. All MWT will be twice blinded analyzed by a single expert to minimize variability of interpretation.

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.

Primary outcome measures

• Mean sleep latency of the MWT [Time frame: v2 (up to 90 days after V0)]

Secondary outcome measures (12)

• Bordeaux Sleepiness Scale [Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)]
• Chronotype [Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)]
• Sleepiness (1) [Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)]
• Sleepiness (2) [Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)]
• Sleepiness (3) [Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)]
• Sleepiness (4) [Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)]
• Quality of life (1) [Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)]
• Quality of life (2) [Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)]
• Quality of life (3) [Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)]
• Sleep behaviors [Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)]
• Appropriate disorder (1) [Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)]
• Appropriate disorder (2) [Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Basic science

Study locations

France · 4 centers

• CHU de Bordeaux — Bordeaux
• CHU de Montpellier — Montpellier
• APHP - Hôtel-Dieu — Paris
• APHP - la Pitié-Salpêtrière — Paris

Identifiers

NCT: NCT07120061 · CHUBX 2024/88

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗