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临床试验/NCT00232544
NCT00232544已完成不适用

RCT of a Telecommunications System in Sleep Apnea

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2004年10月最近更新:
适应症
干预措施

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

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

Placebo Comparator

A TLC system for providing general health education

干预措施: TLC-Control (Other)

TLC-CPAP

Experimental

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)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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Telecommunications System in Sleep Apnea | 临床试验