Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation

描述(由申请人提供)： 阻塞性睡眠呼吸暂停(OSA)是冠心病患者中的一种非常常见的疾病，与运动能力受损、功能受限和与健康相关的生活质量下降有关。我们假设OSA患者的识别和治疗 接受心脏康复治疗将改善康复反应。这项拟议的研究将通过一项平行分组的随机临床试验来验证这一假设，在接受心脏康复治疗的患者中，比较采用持续气道正压(CPAP)的OSA治疗和教育对照组，这些患者筛查出以前未诊断出的OSA呈阳性。受试者将是在退伍军人波士顿医疗系统接受心脏康复治疗的退伍军人。所有同意接受心脏康复治疗的男性或女性患者都将接受OSA的家庭睡眠测试，那些中度到重度OSA(AHI&gt；15)的患者将继续进行临床试验，除非他们有危险的嗜睡程度(Epworth嗜睡量表评分16或过去2年内有在驾驶汽车时睡着的报告)。受试者将随机接受CPAP治疗或健康生活方式和睡眠教育对照治疗。治疗将通过完成为期12周、每周3次的监督心脏康复计划而继续进行。结果测量将在基线上进行，并在12周计划结束时重复。主要结果将是症状受限心肺运动试验的最高耗氧量，其次是通风效率和无氧阈值、6分钟步行距离、世界卫生组织残疾评估量表II和医疗结果研究SF36生活质量问卷。我们将筛选多达150名转诊为心脏康复的患者，以确定50名中到重度OSA患者进行随机分组。这个样本量将提供80%的功率来检测峰值O2消耗的2.5ml/min/kg的绝对差异，假设峰值O2消耗的SD变化为3.6ml/min/kg，则为之前两项独立于心脏康复的运动对OSA的影响的平均值。

DESCRIPTION (provided by applicant): 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. We 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. Subjects will be Veterans who have been referred for cardiac rehabilitation at the VA Boston Healthcare System. All consenting male or female patients referred for cardiac rehabilitation will undergo home sleep testing for OSA, and those with moderate to severe OSA (AHI >15) will continue into the clinical trial, unless they have 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). Subjects will be randomized to treatment with CPAP or to treatment with a healthy lifestyle and sleep education control. Treatment will be continued through the completion of a 12-week, 3-session per week supervised cardiac rehabilitation program. Outcome measures will be made at baseline and repeated at the end of the 12-week program. The primary outcome will be peak O2 consumption on symptom-limited cardiopulmonary exercise testing, with secondary measures of ventilatory efficiency and anaerobic threshold, 6-minute walk distance, World Health Organization Disability Assessment Scale II, and Medical Outcomes Study SF36 Quality of Life Questionnaire. We will screen up to 150 patients referred for cardiac rehabilitation, in order to identify 50 patients with moderate to severe OSA for randomization. This sample size will provide 80% power to detect a 2.5 ml/min/kg absolute difference in peak O2 consumption, the mean of the effect reported in two previous studies of exercise in OSA independent of cardiac rehabilitation, assuming a SD of change in peak O2 consumption of 3.6 ml/min/kg.