Residual Sleepiness and Accident Risk in Treated Obstructive Sleep Apnea

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест 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

Первичные конечные точки

• Baseline Hypoxic Burden According to Post-Treatment Vigilance Status [Срок оценки: after a minimum of 28 days of treatment]

Вторичные конечные точки (3)

• Correlation Between Baseline Hypoxic Burden and Mean Sleep Latency on the Maintenance of Wakefulness Test [Срок оценки: After a minimum of 28 days of treatment.]
• Predictive Value of Baseline Polysomnographic and Psychobehavioral Markers for Maintenance of Wakefulness Test Results [Срок оценки: 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 [Срок оценки: From hospital admission to hospital discharge, with alternative vigilance tests performed on the day preceding and the day of the Maintenance of Wakefulness Test]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 1 центр

• Hopital Lyon Croix Rousse — Lyon

Идентификаторы

NCT: NCT07545421 · 69HCL24_1173

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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