RCT of a Telecommunications System in Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Objective CPAP Use
研究概览
简要总结
This study is investigating the effects of a telecommunications system designed to improve patient adherence with prescribed positive airway pressure (CPAP).
详细描述
Background/Rationale:
Obstructive sleep apnea syndrome (OSAS) is an important chronic disease of adults, affecting an estimated 4% of men and 2% of women in the United States. Nasal continuous positive airway pressure (CPAP) has been demonstrated to ameliorate the symptoms and neurobehavioral consequences of OSAS. Unfortunately, patient adherence with prescribed CPAP is low, diminishing the benefits obtained from this expensive therapy. Nurse-administered patient education and monitoring of CPAP use through home visits has been shown to be effective in significantly improving CPAP adherence. Given the logistic complexity of delivering this service and its costs, it is unlikely to be disseminated widely into clinical practice. An alternative, using advanced telecommunications technology to deliver similar adherence improvement services, is proposed for study.
Objective(s):
Use of telecommunications systems with other important health-related behaviors such as medication-taking, diet, and exercise have demonstrated significant improvements in therapy adherence.
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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 obstructive sleep apnea syndrome plus polysomnography demonstrating greater than 10 apneas plus hypopneas per hour of sleep
- •Age 18-80 years
- •Ability to use a telephone without assistance
排除标准
- 未提供
研究组 & 干预措施
TLC-Control
A TLC system for providing general health education
干预措施: TLC-Control (Other)
TLC-CPAP
A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
干预措施: Telecommunications system (Device)
结局指标
主要结局
Objective CPAP Use
时间窗: 12 months
Mean nightly hours of CPAP use over 12 months
次要结局
- Daytime Vigilance(12 months)
