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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Baseline Hypoxic Burden According to Post-Treatment Vigilance Status
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
This is an open-label interventional study with no masking of participants or investigators.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Treated Obstructive Sleep Apnea Patients
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
干预措施: Hypoxic burden computation, additional procedures and questionnaire (Diagnostic Test)
结局指标
主要结局
Baseline Hypoxic Burden According to Post-Treatment Vigilance Status
时间窗: after a minimum of 28 days of treatment
Baseline hypoxic burden measured on diagnostic polysomnography, quantified as the cumulative depth and duration of oxygen desaturations associated with respiratory events. The primary analysis compares hypoxic burden between patients with impaired vigilance and those without impaired vigilance, defined by a mean sleep latency \<33 minutes on the Maintenance of Wakefulness Test after treatment.
次要结局
- Correlation Between Baseline Hypoxic Burden and Mean Sleep Latency on the Maintenance of Wakefulness Test(After a minimum of 28 days of treatment.)
- Predictive Value of Baseline Polysomnographic and Psychobehavioral Markers for Maintenance of Wakefulness Test Results(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(From hospital admission to hospital discharge, with alternative vigilance tests performed on the day preceding and the day of the Maintenance of Wakefulness Test)