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临床试验/NCT00984308
NCT00984308已完成2 期

Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease

VA Office of Research and Development4 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2008年12月23日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
225
试验地点
4
主要终点
Sleep Apnea Diagnosis Rate

研究概览

简要总结

Sleep apnea is common among Veterans with cerebrovascular disease (stroke or transient ischemic attack [TIA]), leads to hypertension, and is associated with recurrent stroke and death. Although continuous positive airway pressure (CPAP) safely treats sleep apnea, few Veterans with cerebrovascular disease are diagnosed with sleep apnea or offered treatment.

详细描述

The project sought to evaluate whether a diagnostic and therapeutic intervention strategy among Veterans with cerebrovascular disease and hypertension using unattended polysomnography and auto-titrating CPAP with a targeted adherence evaluation and educational protocol resulted in: an improved rate of diagnosed sleep apnea, an improved rate of treated sleep apnea, and improved blood pressure control.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stroke or Transient Ischemic Attack Hypertension

排除标准

  • Prior diagnosis of sleep apnea or other sleep disorder
  • Life expectancy < 6 months or Hospice
  • Non-English speaker
  • Unable/unwilling to use mask
  • Inability to give informed consent
  • Oxygen dependent COPD
  • Chronic renal failure with dialysis
  • Active Suicidal Ideation

结局指标

主要结局

Sleep Apnea Diagnosis Rate

时间窗: The entire study period (baseline and up to one-year)

The number of patients with a diagnosis of sleep apnea

Hypertension Control

时间窗: One year

Medication-Adjusted Systolic Blood Pressure

次要结局

  • Sleep Apnea Treatment Rate(One year)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (4)

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