Residual Sleepiness and Accident Risk in Treated Obstructive Sleep Apnea

Starting soon · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

Obstructive sleep apnea (OSA) is a major cause of excessive daytime sleepiness and impaired vigilance, leading to an increased risk of road and occupational accidents. Despite effective treatment with continuous positive airway pressure (CPAP) or mandibular advancement devices, more than one third of treated patients report persistent subjective sleepiness and/or objective vigilance impairment. The Maintenance of Wakefulness Test (MWT) is currently considered the legal reference test for the assessment of vigilance. However, its availability is limited and does not allow systematic and regular evaluation of all patients at risk. This prospective study aims to identify determinants of residual daytime sleepiness and impaired vigilance in treated OSA, with a specific focus on the role of hypoxic burden at diagnosis. The study also aims to evaluate alternative behavioral and psychomotor tests as potential complementary tools to the MWT, and to assess their relationship with simulated driving performance and retrospective accident history.

Key facts

Study ID

NCT07545421

Run by

Hospices Civils de Lyon

People needed

100

Starts

2026-05-01

Expected to finish

2029-05-01

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 18 years or older.
• Newly diagnosed moderate to severe obstructive sleep apnea, defined by an apnea-hypopnea index (AHI) ≥15 events/hour on diagnostic polysomnography.
• Indication for obstructive sleep apnea treatment (continuous positive airway pressure, mandibular advancement device, positional therapy, or wake-promoting pharmacological treatment) as determined by the treating clinician.
• Indication for Maintenance of Wakefulness Test due to reported sleepiness, declared or suspected accident risk, or professional driving or safety-related occupation.

You may not qualify if…

• Previous treatment for obstructive sleep apnea.
• Major cognitive impairment or language barrier preventing valid completion of vigilance tests or questionnaires.
• Refusal or inability to undergo the Maintenance of Wakefulness Test.
• Comorbid sleep disorders associated with hypersomnolence, including narcolepsy or idiopathic hypersomnia.
• Pregnant or breastfeeding women.
• Persons deprived of liberty by judicial or administrative decision, persons under legal protection (guardianship or curatorship), persons admitted to a health or social institution for reasons other than research, persons receiving compulsory psychiatric care, or persons not affiliated with a social security system or equivalent.

Where it is running

• Hopital Lyon Croix Rousse — Lyon, France

Full record on ClinicalTrials.gov

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