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低通气（OSAH）是一种常见的慢性疾病， 与日间嗜睡、健康相关生活质量（QOL）受损以及 高血压和心血管疾病。最常见的治疗方法是持续气道正压通气 （CPAP），尽管超过三分之一的患者对CPAP的依从性较差。减肥可以明显 减轻OSAH的严重程度，但尽管短期饮食减肥往往可以实现，但很难 保持。在观察性研究中，规律的有氧运动与OSAH的低患病率相关 在调整体型后，在两个小型临床试验中， 尽管体重减轻很少或没有减轻，但OSAH严重程度显著降低。证明饮食减肥 和适度的体力活动，通过在家庭环境中易于管理的远程保健应用程序来促进， 独立改善OSAH严重程度将对OSAH的治疗方法产生重大影响， 这种疾病在VA人群中非常普遍。 项目目标。我们假设，中等强度的体力活动和饮食减肥都将 独立地降低OSAH严重程度和日间嗜睡并改善OSAH相关QOL。我们进一步 假设饮食和体力活动的影响将通过肥胖的变化来介导，特别是 局部脂肪分布和上气道尺寸的变化可能与体重减轻无关。的 具体的目标是确定（1）六种药物对OSAH严重程度、日间嗜睡和生活质量的影响。 6个月的中等强度体力活动促进和（2）6个月的饮食减肥促进。 此外，我们将确定身体活动促进干预对身体活动的影响， 减肥促进干预对BMI的影响。第二个目标是确定 这些干预措施对区域脂肪分布和上气道尺寸的影响， 干预措施对OSAH的影响。 项目方法。拟议的研究是一项随机临床试验，采用2 × 2析因设计来检验 体力活动和饮食干预的独立影响，以及注意力控制干预， 受试者未被分配到任何一种积极干预。受试者将是180名年龄在18-80岁之间的男女退伍军人 年，BMI 25-40 kg/m2，医生诊断为OSAH，呼吸暂停低通气指数（AHI）>10/hr 不依从CPAP治疗的患者。体力活动干预是6个月的渐进式步行 使用Windows移动的计算机技术进行心率监测和实时反馈的方案， 允许在家庭环境中自我给药。饮食减肥干预是一个为期6个月的计划 根据VA的MOVE！程序.成果 包括来自多导睡眠图的AHI、埃普沃思嗜睡量表评分、 睡眠问卷，BMI，体力活动，内脏和皮下腹部脂肪的超声测量， 和上呼吸道尺寸。