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临床试验/NCT01108081
NCT01108081已完成3 期

An RCT of Telemedicine Interventions for OSA

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2010年10月最近更新:
适应症

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

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)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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