An interventional study of First MWT and second MWT in Disorders of Excessive Somnolence, sponsored by University Hospital, Bordeaux. Recruiting at 4 sites in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Basic science
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.
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.
173 studies on the registry are indexed under Disorders of Excessive Somnolence; 34 are open to participants now.
This study's planned enrollment of 100 is above the median of 90 across 133 interventional studies indexed under Disorders of Excessive Somnolence.
Browse Disorders of Excessive Somnolence studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Plus one of the following inclusion criteria:
Exclusion Criteria:
Patient with obstructive sleep apnea (OSA) before/without treatment for OSA
Diagnostic Test: First MWT · Diagnostic Test: second MWT · Device: actimetry
Patient with obstructive sleep apnea (OSA) treated for OSA
Diagnostic Test: First MWT · Diagnostic Test: second MWT · Device: actimetry
Participants with type 1 narcolepsy
Diagnostic Test: First MWT · Diagnostic Test: second MWT · Device: actimetry
Healthy volunteers
Diagnostic Test: First MWT · Diagnostic Test: second MWT · Device: actimetry
MWT during the first visit of the protocol
MWT during the second visit of the protocol
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.
Mean sleep latency of the MWT
Sleep latency value in the wakefulness maintenance test.
Time frame: v2 (up to 90 days after V0)
Bordeaux Sleepiness Scale
Self-reported traffic accidents or near-misses related to sleepiness and sleepiness at the wheel. 4-items questionnaire. Total score of 8 points. If the score is 3 or higher, the prediction of the risk of a sleep-related accident or near miss is defined as positive.
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Chronotype
Self-reported chronotype (reduced Morningness-Eveningness Questionnaire) It consists of 5 questions, each with a scoring system ranging from 1 to 5 points (depending on the answers), giving a total score ranging from 4 to 25. The lower the score, the more "evening" the chronotype; the higher the score, the more "morning" the 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)
Self-reported sleepiness using : \- the Epworth Sleepiness Scale, 8-items, the total score ranges from 0 (normal sleepiness) to 24 (pathological sleepiness)
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)
Self-reported sleepiness using : \- the Hypersomnia Severity Index, 9-items, the total score ranges from 0 (no hypersomnia) to 36 (Very severe Hypersomnia)
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)
Self-reported sleepiness using : \- the Insomnia Severity Index, 7 items, the total score ranges from 0 (no insomnia) to 28 (Severe insomnia)
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)
Self-reported sleepiness using : \- Functional Outcomes of Sleep Questionnaire, 10 items. The total score ranges from 5 ( Significant alteration) to 20 (no alteration)
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)
Self reported quality of life with : \- EQ-5D, total score from 0 (Worst possible health) to 100 ( Best possible health)
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)
Self reported quality of life with : \- Fatigue Severity Scale, 9 items, total score from 1 (Absence or low fatigue) to 7( Severe fatigue, with marked repercussions)
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)
Self reported quality of life with : \- Toronto Hospital Alertness Test, 10 items, total score from 0 (Impaired alertness (low alert)) to 50 (Good vigilance/sufficient alertness)
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
Objective sleep behaviors (sleep duration, sleep regularity, sleep timing, using the 2-weeks actigraphy and sleep diary).
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)
Self-reported severity scale for appropriate disorder using : * The Patient Reported Apnea Questionnaire, 16 items (from 0 to 5), The higher the score, the greater the negative impact of Obstructive Sleep Apnea. * The Narcolepsy Severity Scale, 15 items, the higher the score, the more severe the symptoms.
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)
Self-reported severity scale for appropriate disorder using : \- The Narcolepsy Severity Scale, 15 items, the higher the score, the more severe the symptoms.
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Mental complaints (1)
Mental complaints using : \- The Generalized Anxiety Disorder-7, 7 items, total score from 0 (no anxiety) to 21(severe anxiety)
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Mental complaints (2)
Mental complaints using : \- The Perceived Stress Scale, 10 items, total score from 0 (Low stress) to 40 (High stress)
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Mental complaints (3)
Mental complaints using : \- The Psychological-Physical-Pain Visual Analogue Scale, 3 items from 0 (no pain) to 100 (maximal pain)
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Mental complaints (4)
Mental complaints using : \- The Adult Self-Report Scale, 18 items, total score from 0(no symptom) to 72 (very frequent/severe symptoms)
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Mental complaints (5)
Mental complaints using : \- The Participant Health Questionnaire-9, 9 items, total score from 0(no depression) to 27 (severe depression)
Time frame: at Baseline (day 0), v1 (up to 88 days after day 0) and v2 (up to 90 days after day 0)
Plan to share: No
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Disorders of Excessive Somnolence→
University Hospital, Bordeaux