Effect of Continuous Positive Airways Pressure (CPAP) in Women With Moderate-to-severe Obstructive Sleep Apnea (OSA). A Multicenter, Randomized, Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 307
- 试验地点
- 2
- 主要终点
- Change from baseline in quality of life on the Quebec Sleep Questionnaire (QSQ) at week 12
研究概览
简要总结
The purpose of this study is to determine whether Continuous Positive Airways Pressure (CPAP) improves quality of life, cardiovascular (blood pressure) and metabolic profile (glucose and lipid metabolism) in females with moderate-to-severe Obstructive Sleep Apnea (OSA).
详细描述
Study Design: multicenter, open-label, randomized, controlled trial of parallel groups with a final blind evaluation.
Study sites. The following hospitals will participate in the study: Valme (Sevilla), la Fe (Valencia), Virgen del Rocío (Sevilla), Gral Yagüe (Burgos), San Pedro de Alcántara (Cáceres), Dr Peset (Valencia), Severo Ochoa (Madrid), Reina Sofía (Córdoba), Dr Negrín (Las Palmas de Gran Canaria), Virgen de la Victoria (Málaga), Río Hortega (Valladolid), Costa del Sol (Málaga), Marqués de Valdecilla (Santander), Albacete (Albacete), Virgen del Puerto (Cáceres), Puerta de Hierro (Madrid), Consorcio Sanitario de Terrassa (Barcelona), Getafe (Madrid), Gral de Alicante (Alicante), Morales Meseguer (Murcia), Tomelloso (Ciudad Real), and Fundación Jiménez Díaz (Madrid). All centers from Spain.
Methods: consecutive outpatient women aged 18-75 years and referred to the sleep clinics for suspicion of OSA will be studied. They will undergo a diagnostic home respiratory polygraphy, and those diagnosed with moderate-to-severe OSA (AHI ≥15) will be eligible for this study and randomized to optimal CPAP treatment or conservative treatment for 12 weeks. Every women will fulfill a standardized protocol and different quality of life questionnaires. Office blood pressure will be measured. Fasting blood samples will be collected to assess glucose and lipid metabolism. All the measurements will be performed at baseline and after 12 weeks of follow-up. Women will be examined at the time of inclusion, after 4 weeks of follow-up and at the end of follow-up (12 weeks).
149 women with moderate-to-severe OSA need to be enrolled in each study arm, according to the sample size calculated to achieve a clinically significant improvement in the Quebec Sleep Questionnaire. The results will be analyzed both on an intention-to-treat basis and on a per-protocol basis (data only from patients who finish the study and show good adherence to CPAP, defined as an average objective use of at least 4 hours/day).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Moderate-to-severe OSA (Apnea-Hypopnea index ≥15) diagnosed by Home Respiratory Polygraphy.
- •Age between 18-75 years.
排除标准
- •diagnosis of narcolepsy or restless legs syndrome
- •unstable cardiovascular profile (cardiovascular event in the previous 3 months)
- •cancer or life expectancy lower than 1 year
- •uncontrolled psychiatric disorders
- •central sleep apnea (>50% of central events)
- •pregnancy
- •risky jobs and severe hypersomnolence (Epworth >=18) requiring urgent treatment
- •either respiratory failure (SaO2<90% or partial oxygen pressure [pO2] <60 mmHg or Long-term O2 therapy
- •heart failure (New York Heart Association class III-IV)
- •prior CPAP therapy
结局指标
主要结局
Change from baseline in quality of life on the Quebec Sleep Questionnaire (QSQ) at week 12
时间窗: Baseline, 12 weeks.
次要结局
- Change from baseline in mood state on the Abbreviated Profile Of Mood States (POMS) at week 12(Baseline, 12 weeks)
- Change from baseline in sleep apnea symptoms at week 12(baseline, 12 weeks)
- Change from baseline in lipid metabolism at week 12(baseline, 12 weeks)
- Change from baseline in quality of life on the 12-Item Short Form Health Survey (SF-12) at week 12(baseline, 12 weeks)
- Change from baseline in glucose metabolism at week 12(baseline, 12 weeks)
- Change from baseline in sleepiness on the Epworth Sleepiness Score (ESS) at week 12(baseline, 12 weeks)
- Change from baseline in blood pressure at week 12(Baseline, 12 weeks)
- Change from baseline in anxiety and depression on the Hospital Anxiety and Depression questionnaire (HAD) at week 12(baseline, 12 weeks)
- Change from baseline in quality of life on the Visual Analogic Scale (VAS) at week 12(baseline, 12 weeks)
研究者
Francisco Campos-Rodriguez
Pneumology specialist
Sociedad Española de Neumología y Cirugía Torácica