Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation

阻塞性睡眠呼吸暂停治疗可改善心脏康复

• 批准号: 8825957
• 负责人: Daniel J Gottlieb
• 金额: --
• 依托单位: VA BOSTON HEALTH CARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-01 至 2017-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8825957
• 关键词: Activities of Daily Living; Adult; Anaerobic Threshold; Blood Pressure; Blood Vessels; Boston; Cardiac; Cardiac Death; Cardiac rehabilitation; Cardiopulmonary; Case Series; Cause of Death; Cessation of life; Clinical Trials; Consent; Consumption; Continuous Positive Airway Pressure; Control Groups; Coronary heart disease; Disease; Education; Educational Intervention; Effectiveness; Exercise; Exercise Tolerance; Exercise stress test; Fatigue; Female; Glucose; Goals; Health; Healthcare Systems; Home environment; Hypoxemia; Hypoxia; Inflammation; Intervention; Measures; Medical; Motivation; Myocardial Infarction; Obesity; Obstructive Sleep Apnea; Outcome Measure; Outcome Study; Oxygen Consumption; Patients; Patterns of Care; Performance; Prevalence; Psychosocial Factor; Quality of life; Questionnaires; Randomized; Randomized Clinical Trials; Recurrence; Rehabilitation therapy; Reporting; Research; Risk; SF-36; Sample Size; Skeletal Muscle; Sleep; Sleep Apnea Syndromes; Sleep Fragmentations; Symptoms; Testing; Time; Training; United States; Veterans; Walking; World Health Organization; clinical practice; disability; falls; functional status; health related quality of life; healthy lifestyle; improved; male; meetings; mortality; primary outcome; programs; response; screening; shear stress; treatment duration; trial comparing

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.

描述（由申请人提供）： 阻塞性睡眠呼吸暂停 (OSA) 是冠心病患者中一种非常常见的疾病，与运动能力受损、功能受限和健康相关生活质量下降有关。我们假设患者 OSA 的识别和治疗 接受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、随机临床试验来检验这一假设，该试验将持续气道正压通气 (CPAP) 的 OSA 治疗与教育对照组的患者进行比较，这些患者接受心脏康复，且先前未诊断的 OSA 筛查呈阳性。受试者将是被转介到 VA 波士顿医疗系统进行心脏康复的退伍军人。所有同意转诊进行心脏康复的男性或女性患者都将接受 OSA 的家庭睡眠测试，患有中度至重度 OSA（AHI > 15）的患者将继续进入临床试验，除非他们有危险的嗜睡程度（Epworth 嗜睡量表评分 > 16 或有过去 2 年内在开车时睡着的报告）。受试者将被随机分配接受 CPAP 治疗或接受健康生活方式和睡眠教育控制的治疗。治疗将持续到完成为期 12 周、每周 3 次的监督心脏康复计划。结果测量将在基线时进行，并在 12 周计划结束时重复。主要结果将是症状限制心肺运动测试中的峰值 O2 消耗量，次要指标是通气效率和无氧阈、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。我们将对最多 150 名转诊进行心脏康复的患者进行筛查，以确定 50 名患有中度至重度 OSA 的患者进行随机分组。此样本量将提供 80% 的功效来检测峰值 O2 消耗量的 2.5 ml/min/kg 绝对差异，这是之前两项 OSA 运动研究中报告的效果的平均值，与心脏康复无关，假设峰值 O2 消耗量变化的 SD 为 3.6 ml/min/kg。