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普遍的疾病，并且与运动能力受损、功能受限和与健康相关的生活质量降低相关。我们假设，患者中OSA的识别和治疗 进行心脏康复将改善对康复的反应。拟议的研究将使用一项平行组、随机、临床试验来测试这一假设，该试验将在接受心脏康复治疗的患者中使用持续气道正压通气（CPAP）治疗OSA与教育对照组进行比较，这些患者对先前未诊断的OSA筛查呈阳性。受试者将是在VA波士顿医疗保健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的男性或女性患者将接受OSA的家庭睡眠测试，中度至重度OSA（AHI >15）的患者将继续参加临床试验，除非他们有危险的嗜睡水平（埃普沃思嗜睡量表评分>16或过去2年内在开车时睡着的报告）。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。治疗将持续至完成为期12周、每周3次的监督心脏康复计划。将在基线时进行结果测量，并在12周计划结束时重复测量。主要结局将是限制性心肺运动试验中的峰值O2消耗量，次要指标为呼吸效率和无氧阈值、6分钟步行距离、世界卫生组织残疾评估量表II和医学结局研究SF 36生活质量问卷。我们将筛选多达150名转诊接受心脏康复的患者，以确定50名中重度OSA患者进行随机分组。该样本量将提供80%的把握度来检测峰值O2消耗量的2.5 ml/min/kg绝对差异，这是先前两项独立于心脏康复的OSA运动研究中报告的效应平均值，假设峰值O2消耗量变化的SD为3.6 ml/min/kg。

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.