Impact of Obstructive Sleep Apnea Biomarkers on Adherence to Continuous Positive Airway Pressure: Role of Pulse Wave Amplitude Drop Index, Hypoxic Burden, and Heart Rate Variability
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Association Between Baseline Hypoxic Burden and CPAP Adherence at 3 Months
研究概览
简要总结
Obstructive sleep apnea (OSA) is commonly assessed using the apnea-hypopnea index, although this measure does not fully reflect cardiovascular risk or the physiological impact of the disease. Emerging biomarkers, including sleep apnea-specific hypoxic burden, pulse wave amplitude drop index, and heart rate response, may provide additional information on cardiovascular vulnerability.
This prospective multicenter observational study will investigate the association between these biomarkers, measured from the diagnostic sleep study, and adherence to continuous positive airway pressure (CPAP) therapy after three months. Symptoms, quality of life, clinical characteristics, and changes in biomarkers under continuous positive airway pressure will also be evaluated.
详细描述
This is a prospective, longitudinal, multicenter observational cohort study involving adults with newly diagnosed obstructive sleep apnea for whom continuous positive airway pressure therapy is indicated as part of routine clinical care.
At baseline, demographic and clinical characteristics, medical history, current treatments, symptom questionnaires, and results from diagnostic respiratory polygraphy or polysomnography will be collected. Hypoxic burden, pulse wave amplitude drop index, and heart rate response will be calculated from the initial sleep recording. Continuous positive airway pressure will be prescribed according to standard clinical practice.
At 12 weeks, with a permitted window of plus or minus four weeks, adherence data will be obtained from the continuous positive airway pressure device. Clinical information and questionnaires will be collected again. Participants requiring a follow-up sleep study as part of routine care may undergo respiratory polygraphy or polysomnography while receiving continuous positive airway pressure, allowing assessment of biomarker changes under treatment.
The principal analysis will examine associations between baseline biomarkers and continuous positive airway pressure adherence. Secondary analyses will assess biomarker distributions according to clinical characteristics, associations with symptoms and quality of life, and changes in biomarkers during treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Newly diagnosed obstructive sleep apnea with an indication for continuous positive airway pressure therapy
- •Age older than 18 years
- •Written informed consent obtained
排除标准
- •Continuous positive airway pressure treatment during the preceding 3 months
- •Medical contraindication to continuous positive airway pressure therapy
- •Concomitant condition likely to affect adherence to continuous positive airway pressure, including severe cognitive impairment or an unstable psychiatric disorder
研究组 & 干预措施
Patients with newly diagnosed obstructive sleep apnea
Adults with newly diagnosed obstructive sleep apnea and a clinical indication for continuous positive airway pressure therapy. Treatment is prescribed according to routine clinical practice. Participants are followed for three months to evaluate treatment adherence, symptoms, quality of life, and sleep apnea biomarkers.
干预措施: Continuous Positive Airway Pressure (Device)
结局指标
主要结局
Association Between Baseline Hypoxic Burden and CPAP Adherence at 3 Months
时间窗: Baseline to 3 months after CPAP initiation
Association between hypoxic burden measured during the baseline diagnostic sleep study and mean nightly CPAP use during the 30 days preceding the 3-month visit. CPAP adherence will also be categorized as less than 4 hours per night versus 4 hours or more per night.
次要结局
- Distribution of Baseline Sleep Apnea Biomarkers(BASELINE)
- Association Between Baseline Heart Rate Response and CPAP Adherence at 3 Months(Baseline to 3 months after CPAP initiation)
- Association Between Baseline Pulse Wave Amplitude Drop Index and CPAP Adherence at 3 Months(Baseline to 3 months after CPAP initiation)
- Daytime Sleepiness Assessed by the Epworth Sleepiness Scale(Baseline and 3 months)
- Health-Related Quality of Life Assessed Using the EuroQol 5-Dimension 5-Level Questionnaire(baseline and 3 months)
- Goal Attainment Assessed by Goal Attainment Scaling(baseline and 3 months)
- Change in Sleep Apnea-Specific Hypoxic Burden During CPAP Therapy(baseline and 3 months)
- Change in Pulse Wave Amplitude Drop Index During CPAP Therapy(Baseline and 3 months after CPAP initiation)
- Change in Heart Rate Response to Respiratory Events During CPAP Therapy(Baseline and 3 months after CPAP initiation)
研究者
Bughin Francois
Principal investigator
Clinique du Millenaire