An RCT of Telemedicine Interventions for OSA
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 2
- 主要终点
- Change Over 6 Months in Epworth Sleepiness Scale Score
研究概览
简要总结
This project is investigating whether both moderate-intensity physical activity and dietary weight loss will independently reduce sleep apnea symptoms and improve quality of life.
详细描述
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 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.
Objective:
The investigators hypothesize that both moderate-intensity physical activity and dietary weight loss will independently reduce OSAH severity and improve QOL.
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician diagnosis of sleep apnea
- •Apnea-hypopnea index >10/hr
- •BMI over 24 kg/m2
排除标准
- •Angina pectoris
- •History of myocardial infarction within 6 months
结局指标
主要结局
Change Over 6 Months in Epworth Sleepiness Scale Score
时间窗: baseline and 6 months
Epworth Sleepiness Scale score, change in score from baseline to 6 months. Total scores range from 0-24, where higher scores indicate more sleepiness.
次要结局
- Change Over 6 Months in Quality of Life(baseline and 6 months)
