Why some treated sleep apnea patients stay sleepy and at risk of accidents
Looks at causes of lingering sleepiness in treated obstructive sleep apnea, including oxygen drops.
Key facts
- Who runs it
- Hospices Civils de Lyon
- Where
- Lyon, FranceSee the site
- Trial code
- Registry title
- Residual Sleepiness and Accident Risk in Treated Obstructive Sleep Apnea
- Status
- Not yet recruiting
- People taking part
- 100 people, planned
- Started
- 1 May 2026
- Expected to end
- 1 May 2029
- Type of study
- Interventional
- Treatments tested
- Hypoxic burden computation, additional procedures and questionnaire
- Record updated
- 22 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults newly diagnosed with moderate to severe obstructive sleep apnea who will start treatment. A sleep doctor must also have asked for a daytime wakefulness test (Maintenance of Wakefulness Test).
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Newly diagnosed moderate to severe obstructive sleep apnea, with an apnea-hypopnea index (AHI) of ≥15 events/hour on a sleep study (polysomnography). The doctor must plan treatment, such as CPAP, a mandibular advancement device (mouth splint), positional therapy or a medicine that keeps you awake. The Maintenance of Wakefulness Test must be needed because of sleepiness, accident risk, or professional driving or a safety-related job.
- Earlier treatment
- People who were treated for obstructive sleep apnea before cannot join.
- Biomarker or test result
- Apnea-hypopnea index (AHI) of ≥15 events/hour on diagnostic polysomnography.
Main reasons for not taking part
- Previous treatment for obstructive sleep apnea
- Major memory or thinking problems, or a language barrier, that prevent doing the tests or questionnaires
- Refusing or being unable to do the Maintenance of Wakefulness Test
- Other sleep disorders that cause heavy sleepiness, such as narcolepsy or idiopathic hypersomnia
- Pregnant or breastfeeding women; people under legal protection or deprived of liberty, or without social security
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previous treatment for obstructive sleep apnea
- 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
- Major cognitive impairment or language barrier preventing valid completion of vigilance tests or questionnaires
- Comorbid sleep disorders associated with hypersomnolence, including narcolepsy or idiopathic hypersomnia
- Refusal or inability to undergo the Maintenance of Wakefulness Test
- Pregnant or breastfeeding women
Where in France
- Hopital Lyon Croix RousseLyon, FranceContact: Pierre Tankéré, MD PhDNot yet recruiting
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- Treated Obstructive Sleep Apnea PatientsTreatment being tested
Adult patients diagnosed with moderate to severe obstructive sleep apnea (apnea-hypopnea index ≥15 events/hour), treated with continuous positive airway pressure or mandibular advancement device, and referred for Maintenance of Wakefulness Testing as part of clinical care
Treatment: Hypoxic burden computation, additional procedures and questionnaire
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Why some treated sleep apnea patients stay sleepy and at risk of accidentsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 22 April 2026