Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- WHO Disability Assessment Scale 2 Scores
研究概览
简要总结
This is a randomized clinical trial in U.S. Veterans to evaluate the impact of treatment for obstructive sleep apnea (OSA) on the effectiveness of cardiac rehabilitation, including impact on exercise capacity, disability, and quality of life.
详细描述
Obstructive sleep apnea (OSA) is a highly prevalent condition in patients with coronary heart disease and is associated with impaired exercise performance, functional limitation and reduced health-related quality of life. The investigators hypothesize that identification and treatment of OSA in patients undergoing cardiac rehabilitation will improve the response to rehabilitation. The proposed study will test this hypothesis using a parallel group, randomized, clinical trial comparing OSA treatment with continuous positive airway pressure (CPAP) to an educational control group in patients undergoing cardiac rehabilitation who screen positive for previously undiagnosed OSA.
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 (Outcomes Assessor)
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
- •Veterans referred for cardiac rehabilitation at the VA Boston Healthcare System.
- •Moderate to severe OSA (AHI >15) on home sleep testing.
排除标准
- •Dangerous levels of sleepiness (Epworth Sleepiness Scale score >16 or a report of falling asleep at the wheel of a car within the past 2 years).
- •Physical limitation precluding exercise testing.
研究组 & 干预措施
Continuous Positive Airway Pressure (CPAP)
Continuous positive airway pressure
干预措施: CPAP (Device)
Healthy Lifestyle and Sleep Education (HLSE)
Healthy living and sleep education
干预措施: HLSE (Behavioral)
结局指标
主要结局
WHO Disability Assessment Scale 2 Scores
时间窗: 12 weeks
Functional status as measured by the World Health Organization Disability Assessment Scale 2.0. Score range 0-48 (higher scores indicate more disability).
次要结局
未报告次要终点