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临床试验/ACTRN12608000514303
ACTRN12608000514303已完成不适用

A randomised controlled trial to evaluate a simplified management strategy for moderate-to-severe obstructive sleep apnea comparing improvements in daytime sleepiness in patients managed in primary care (general practitioner assisted by a sleep specialist nurse) versus usual care in a sleep specialist centre

ational Health and Medical Research Council0 个研究点目标入组 250 人开始时间: 2008年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
250

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
25 Years 至 70 Years(—)
性别
All

入选标准

  • Moderate-to-severe obstructive sleep apnea (OSA) - positive on OSA50 screening questionnaire; Epworth sleepiness scale (ESS)>=8 or poorly-controlled hypertension despite 2 or more antihypertensive agents; ApneaLink 3% oxygen desturation index (ODI)>=16

排除标准

  • Body mass index (BMI)>50
  • Neuromuscular disease
  • Significant psychiatric disease which would affect patient's ability to comply with study protocol
  • Cognitive disability that would prevent self management of CPAP
  • Recent hospitalisation for myocardial infarction (MI), unstable angina, cardiac failure, cerebrovascular accident (CVA) or transient ischemic attack (TIA) in past 3 months, and/or New York Heart Association (NYHA) Class 3 or 4
  • Moderate-to-severe respiratory disease (documented hypoxia or awake oxygen saturation <92%)

研究者

发起方
ational Health and Medical Research Council

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