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: 8634626
• 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 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8634626
• 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; Healthcare Systems; Home environment; Hypoxemia; Hypoxia; Inflammation; Intervention; Life Style; 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; improved; male; meetings; mortality; primary outcome; programs; public health relevance; 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）是冠心病患者的高度普遍疾病，与运动障碍，功能限制和与健康相关的生活质量降低有关。我们假设患者对OSA的鉴定和治疗 进行心脏康复将改善对康复的反应。拟议的研究将使用平行组，随机的临床试验检验该假设，该试验将OSA治疗与持续气道压力（CPAP）与接受心脏康复的患者中的教育对照组进行了比较，该试验对先前未经诊断的OSA进行了阳性阳性。受试者将是在VA波士顿医疗保健系统中被转诊为心脏康复的退伍军人。所有转介心脏康复的男性或女性患者都将接受OSA的家庭睡眠测试，并且那些患有中度至重度OSA的人（AHI> 15）将继续进行临床试验，除非他们的嗜睡水平> 16或在过去两年中在汽车中落在汽车中落在汽车中的所有嗜睡水平> 16或报告）。受试者将被随机分配给CPAP治疗，或者通过健康的生活方式和睡眠教育控制进行治疗。通过完成为期12周，每周的3次课程监督心脏康复计划，将继续进行治疗。结果指标将在基线时进行，并在12周计划结束时重复进行。主要结果将是O2峰值消耗率在症状受限的心肺运动测试中，并采用了次级通气效率和厌氧阈值，步行6分钟的步行距离，世界卫生组织障碍评估量表II和医疗结果研究SF36 SF36生活质量问卷。为了鉴定50名中度至重度OSA随机分组的患者，我们将最多筛查150名接受心脏康复的患者。该样本量将提供80％的功率，以检测O2峰值消耗量的2.5 mL/min/kg绝对差异，这是在OSA的两项运动中报告的效果的平均值，而不是心脏康复，假设O2峰值消耗量在3.6 mL/min/kg的峰值消耗量变化中存在SD。