Residual Sleepiness and Accident Risk in Treated Obstructive Sleep Apnea
A legfontosabb adatok
- Ki végzi
- Hospices Civils de Lyon
- Hol
- Franciaország1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Toborzás még nem indult
- Résztvevők
- 100 fő, tervezett
- Kezdés
- 2026. máj. 1.
- Várható befejezés
- 2029. máj. 1.
- A vizsgálat típusa
- Beavatkozással járó
- A vizsgált kezelések
- Hypoxic burden computation, additional procedures and questionnaire
- A regiszteradat frissítve
- 2026. április 22.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
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).
- Életkor
- 18 years or older
- Nem
- All sexes
- A betegség stádiuma
- 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.
- Korábbi kezelés
- People who were treated for obstructive sleep apnea before cannot join.
- Biomarker vagy leletérték
- Apnea-hypopnea index (AHI) of ≥15 events/hour on diagnostic polysomnography.
A részvétel fő kizáró okai
- 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
A regiszter feltételei, szó szerint
Mind a 10 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- 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
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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.
A vizsgálat csoportja
- Treated Obstructive Sleep Apnea PatientsA vizsgált kezelés
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
Kezelés: Hypoxic burden computation, additional procedures and questionnaire
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- 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
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
- A regiszteradat frissítve
- 2026. április 22.