跳至主要内容
临床试验/NCT00800397
NCT00800397已完成不适用

Evaluation of the Noga System: Detecting of Respiratory Related Sleep Disorders in Cardiac Patients

WideMed LTD.1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2007年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
WideMed LTD.
入组人数
80
试验地点
1
主要终点
Detection of Cheyne Stokes respiration

研究概览

简要总结

Medical literature has shown that 1 out of 2 patients that are admitted to the hospital as a cardiac patient, will be found suffering from sleep breathing disorders. The medical literature also shows that there is an advantage of treating the sleep breathing disorders in addition to treating the cardiac disease or evaluating the heart failure condition to provide better clinical outcomes.this study is evaluating the ability to detect sleep and cardiac related breathing disordered.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Patient is hospitalized in the cardiology department or in the sleep lab.
  • Patients who is willing and able to tolerate a full night Polysomnography
  • Patient is not receiving oxygen treatment
  • Patients is 18 years of age or above
  • Patient is able and willing to sign the institution human subjects committee approved Informed Consent Form.

排除标准

  • Patients can not tolerate a full night Polysomnography.
  • Patient is receiving oxygen.
  • Participation in a clinical trial within the last 60 days and during the study.
  • Life expectancy < 1 month.

结局指标

主要结局

Detection of Cheyne Stokes respiration

时间窗: over night

次要结局

  • AH>=15(over night)
  • Sleep and sleep apnea parameters(over night)
  • plethysmography derived respiration signal(over night)
  • Total duration of Cheyne Stokes(over night)

研究者

发起方
WideMed LTD.
申办方类型
Industry

研究点 (1)

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