Residual Sleepiness and Accident Risk in Treated Obstructive Sleep Apnea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypoxic burden computation, additional procedures and questionnaire.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Determinants of Residual Daytime Sleepiness and Accident Risk in Treated Obstructive Sleep Apnea: Impact of Baseline Hypoxic Burden and Evaluation of Alternatives to the Maintenance of Wakefulness Test
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.
Interventions
- Diagnostic test Hypoxic burden computation, additional procedures and questionnaire
Polysomnographic data from diagnostic and treatment nights are collected to compute hypoxic burden and other sleep-related parameters. Procedures performed as part of usual clinical care include the Maintenance of Wakefulness Test and routine clinical questionnaires assessing sleep, sleepiness, insomnia, mood, chronotype and anxiety, including the Karolinska Sleepiness Scale. Additional procedures performed for research purposes include the Osler test, the Psychomotor Vigilance Task, a simulat
Primary outcome measures
- Baseline Hypoxic Burden According to Post-Treatment Vigilance Status [Time frame: after a minimum of 28 days of treatment]
Secondary outcome measures (3)
- Correlation Between Baseline Hypoxic Burden and Mean Sleep Latency on the Maintenance of Wakefulness Test [Time frame: After a minimum of 28 days of treatment.]
- Predictive Value of Baseline Polysomnographic and Psychobehavioral Markers for Maintenance of Wakefulness Test Results [Time frame: After a minimum of 28 days of treatment.]
- Performance on Alternative Vigilance Tests Compared With the Maintenance of Wakefulness Test And Association Between Vigilance Tests and Simulated Driving Performance [Time frame: From hospital admission to hospital discharge, with alternative vigilance tests performed on the day preceding and the day of the Maintenance of Wakefulness Test]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Hopital Lyon Croix Rousse — Lyon
Identifiers
NCT: NCT07545421 · 69HCL24_1173