Can a simple test predict safe driving for sleepy patients?

NCT ID NCT07120061

Knowledge-focused Sponsor: University Hospital, Bordeaux Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how reliable the Maintenance of Wakefulness Test (MWT) is for people who feel very sleepy during the day. Researchers will test 100 participants twice to see if the results are consistent. If the test proves reliable, it could help doctors decide who is safe to drive, addressing a major medical and legal concern.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to: If the test is reliable, it could become a standard tool to decide if people with hypersomnolence can safely drive, improving road safety.
What could go wrong: This is an observational study, not a treatment trial. The test may turn out to be unreliable, which would limit its use in medical and legal settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Disorders of Excessive Somnolence hypersomnia narcolepsy-cataplexy syndrome obstructive sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Disorders of excessive somnolence

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

4 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Can a simple test predict safe driving for sleepy patients?

What the study statuses mean