Phase II Trial of Sleep Apnea Treatment to Reduce Cardiovascular Morbidity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 318
- 试验地点
- 8
- 主要终点
- To compare the effects of nocturnal supplemental oxygen and PAP versus optimized medical management on biomarkers of cardiovascular risk, including:
研究概览
简要总结
This study examines the role of sleep apnea treatment in improving cardiovascular biomarkers.
详细描述
This is a Phase II randomized controlled trial that will evaluate the effects of supplemental nocturnal oxygen or Positive Airway Pressure (PAP) therapy, compared to optimal medical preventive therapy for Cardiovascular Disease (CVD) risk, on biomarkers of CVD risk in Obstructive Sleep Apnea (OSA) patients at high risk for CVD events. The study will focus on patients with moderate to severe OSA but only mild OSA symptoms.
Eligible participants have a history or symptoms of heart disease AND have symptoms of sleep apnea or snoring. Participants will be contributing to medical knowledge about different options that can be used to improve heart disease in people with sleep apnea.
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
- Single (Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •established Coronary Artery Disease or established cardiovascular disease risk factors
- •home sleep test that showed moderately severe sleep apnea
排除标准
- •poorly controlled health
- •currently using supplemental oxygen or PAP for OSA
结局指标
主要结局
To compare the effects of nocturnal supplemental oxygen and PAP versus optimized medical management on biomarkers of cardiovascular risk, including:
时间窗: 3 months
* 24 hour blood pressure (BP) profile * Markers of systemic inflammation * Markers of oxidative stress * Prothrombotic markers * Sympathetic nervous system activity * Cardiac rhythm, impulse generation and ischemia * Dyslipidemia * Glucose regulation * Myocardial stress
次要结局
- Compare the effects of nocturnal supplemental oxygen and PAP versus standard care on patient-reported outcomes, including:(3 months)
- Compare nocturnal supplemental oxygen and PAP on measures of:(3 months)
研究者
Susan Redline
Senior Physician, Division of Sleep Medicine
Brigham and Women's Hospital