NCT00493948已完成不适用
Evaluation of a Portable Device for Assessing Sleep Disordered Breathing in Congestive Heart Failure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Apnea- Hypopnea Index
研究概览
简要总结
The purpose of this study is to evaluate an approved, portable device for assessing Sleep Disordered Breathing in Congestive Heart Failure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Moderate to severe heart failure (as determined via Echocardiogram or treating physician)
排除标准
- •Clinically significant asthma requiring therapy
- •Significant (parenchymal) lung disease
- •Severe pulmonary hypertension
- •Hypercapnia (PCO2 > 60mmHg)
- •Cardiogenic Shock
- •Severe chronic renal failure
- •Narcotic abuse/intravenous drug use (including heart failure due to alcohol abuse or chemotherapy, HIV+ and Hepatitis C)
- •Methicillin- resistant Staphylococcus aureus infection
- •Tracheotomy
- •Enrolled in any concurrent study that may confound the results of this study
- •Nocturnal positive airway pressure or oxygen
- •Inability or refusal to sign patient consent form
- •Inability or refusal to adhere to protocol requirements
结局指标
主要结局
Apnea- Hypopnea Index
时间窗: Overnight
次要结局
未报告次要终点
研究者
研究点 (1)
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