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Not yet recruiting Not applicable NCT07545421

Residual Sleepiness and Accident Risk in Treated Obstructive Sleep Apnea

No applicable phase (e.g. observational)
Conditions: Obstructive Sleep Apnea

Sponsor: Hospices Civils de Lyon

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Interventions
Hypoxic burden computation, additional procedures and questionnaire
DIAGNOSTIC_TEST
Locations 1
France (1)
Hopital Lyon Croix Rousse
Lyon
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.05.2026
Completion date
01.05.2029
Registry ID
NCT07545421
Source
clinicaltrials.gov
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