An RCT of telemedicine interventions for OSA

OSA 远程医疗干预的随机对照试验

• 批准号: 8182124
• 负责人: DAVID W. SPARROW
• 金额: --
• 依托单位: VA BOSTON HEALTH CARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-10-01 至 2014-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8182124
• 关键词: Abdomen; Acoustics; Adherence; Aerobic Exercise; Affect; Age; Alternative Therapies; Apnea; Area; Attention; Body Weight decreased; Body mass index; Cardiovascular Diseases; Caring; Chronic; Chronic Disease; Clinical Trials; Complex; Computers; Continuous Positive Airway Pressure; Coronary heart disease; Diagnosis; Diet; Dimensions; Disease; Education; Effectiveness; Elderly; Exercise; Fatty acid glycerol esters; Feedback; Female; Goals; Health Expenditures; Health Services Accessibility; Healthcare; Heart Rate; Home environment; Hypertension; Hypoxemia; Impaired health; Individual; Intervention; Lead; Link; Low Prevalence; Measures; Mediating; Mediator of activation protein; Methods; Modality; Moderate Exercise; Monitor; Motivation; Obesity; Observational Study; Obstructive Sleep Apnea; Oral Surgical Procedures; Outcome; Patients; Physical activity; Physicians; Polysomnography; Population; Quality of life; Questionnaires; Randomized Clinical Trials; Randomized Controlled Trials; Regimen; Reporting; Risk; Risk Factors; Self Administration; Severities; Sleep; Sleep Fragmentations; Splint Device; Stroke; System; Technology; Telecommunications; Telemedicine; Telephone; Testing; Therapeutic; Time; Ultrasonography; Veterans; Visceral; Walking; Weight; Weight Gain; abdominal fat; actigraphy; base; common treatment; cost; design; functional disability; functional outcomes; handheld mobile device; health related quality of life; improved; indexing; insight; intervention effect; male; medication compliance; middle age; modifiable risk; prevent; programs; routine care; sedentary; subcutaneous; telehealth; vehicular accident; vigilance; weight loss intervention

Project Background/Rationale. Obstructive sleep apnea/hypopnea (OSAH) is a common chronic disease that is associated with daytime sleepiness, impaired health-related quality of life (QOL), and increased risk of hypertension and cardiovascular disease. The most common treatment is continuous positive airway pressure (CPAP), although adherence to CPAP is poor in more than one-third of patients. Weight loss can clearly lessen the severity of OSAH, but although short-term dietary weight loss can often be achieved it is difficult to maintain. Regular aerobic exercise is associated with a lower prevalence of OSAH in observational studies after adjustment for body habitus, and in two small clinical trials moderate exercise was associated with a substantial decrease in OSAH severity despite little or no weight loss. Demonstrating that dietary weight loss and moderate physical activity, promoted via easily administered telehealth applications in the home setting, independently improve OSAH severity will have a major impact on the therapeutic approach to OSAH, a disease that is highly prevalent in the VA population. Project Objectives. We hypothesize that both moderate-intensity physical activity and dietary weight loss will independently reduce OSAH severity and daytime sleepiness and improve OSAH-related QOL. We further hypothesize that the effects of diet and physical activity will be mediated by changes in adiposity, particularly changes in regional fat distribution and upper airway dimensions that may be independent of weight loss. The specific objectives are to determine the effects on OSAH severity, daytime sleepiness, and QOL of (1) six months of moderate-intensity physical activity promotion and (2) six months of dietary weight loss promotion. Furthermore, we will determine the effect of the physical activity promotion intervention on physical activity and the effect of the weight loss promotion intervention on BMI. A secondary objective is to determine the impact of these interventions on regional fat distribution and upper airway dimensions, which are proposed mediators of the effect of the interventions on OSAH. Project Methods. The proposed study is a randomized clinical trial using a 2 x 2 factorial design to test the independent effects of the physical activity and diet interventions, with an attention control intervention for subjects not assigned to either active intervention. Subjects will be 180 male and female veterans age 18-80 years, with a BMI 25-40 kg/m2, with a physician diagnosis of OSAH and apnea-hypopnea index (AHI) >10/hr who are non-adherent to CPAP therapy. The physical activity intervention is a 6-month progressive walking regimen with heart rate monitoring and real-time feedback using Windows Mobile computer technology, permitting self-administration in the home setting. The dietary weight loss intervention is a 6-month program administered in the home setting via a handheld mobile device based on the VA's MOVE! program. Outcomes include the AHI derived from polysomnography, Epworth Sleepiness Scale score, Functional Outcomes of Sleep Questionnaire, BMI, physical activity, ultrasound measures of visceral and subcutaneous abdominal fat, and upper airway dimensions by acoustic pharyngometry.

项目背景/理由。阻塞性睡眠呼吸暂停/脑炎（OSAH）是一种常见的慢性疾病 与白天的嗜睡，与健康相关的生活质量受损（QOL）以及增加的风险有关 高血压和心血管疾病。最常见的治疗方法是连续正气道压力 （CPAP），尽管超过三分之一的患者遵守CPAP较差。减肥可以显然 减轻OSAH的严重程度，但是尽管通常可以实现短期饮食减肥，但很难很难 维持。定期有氧运动与观察性研究中的OSAH患病率较低有关 调整了身体习惯后，在两项小型临床试验中，适度运动与 尽管减肥很少或没有，但OSAH严重程度的大幅下降。证明减肥 和适度的体育锻炼，通过在家庭环境中易于管理的远程医疗应用来促进 独立提高OSAH的严重性将对OSAH的治疗方法产生重大影响， 在VA人群中非常普遍的疾病。 项目目标。我们假设中等强度的体育活动和饮食减肥都将 独立降低OSAH的严重程度和白天的嗜睡并改善与OSAH相关的QOL。我们进一步 假设饮食和体育锻炼的影响将由肥胖的变化介导，尤其是 区域脂肪分布和上空尺寸的变化可能与体重减轻无关。这 具体目标是确定对OSAH严重程度，白天嗜睡和QOL的影响（1）六 中等强度的体育活动促进和（2）六个月的饮食减肥促进。 此外，我们将确定体育活动促进干预对体育锻炼和 减肥促进干预对BMI的影响。次要目标是确定影响 这些关于区域脂肪分布和上呼吸道尺寸的干预措施，这是拟议的调解人 干预对OSAH的影响。 项目方法。拟议的研究是一项使用2 x 2阶乘设计的随机临床试验，以测试 体育锻炼和饮食干预的独立影响，以及注意力控制干预措施 受试者未分配任何主动干预。受试者将是18-80岁的180名男性和女性退伍军人 年份，具有BMI 25-40 kg/m2，医师诊断为OSAH和呼吸暂停指数（AHI）> 10/hr 对CPAP治疗的不遵守者。体育锻炼干预是一个6个月的渐进式步行 使用Windows移动计算机技术进行心率监测和实时反馈的方案， 允许在家庭环境中进行自我管理。饮食减肥干预是一个为期6个月的计划 根据VA的移动，通过手持移动设备在家庭设置中管理！程序。结果 包括来自多个多摄影的AHI，Epworth嗜睡量表评分，功能结果 睡眠问卷，BMI，体育活动，内脏和皮下腹部脂肪的超声测量， 和上呼吸道尺寸通过声学咽法。