NCT02356367撤回不适用
French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS, AirCurve 10 CS): Predictive Factors of Poor Compliance
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- ResMed
- 试验地点
- 3
- 主要终点
- to define the phenotype of compliant or not compliant patients to sleep disordered breathing therapy using microneurography
研究概览
简要总结
The purpose of this study is to determine the predictive factors of poor compliance to sleep disordered breathing therapy in chronic heart failure patients treated for central sleep apnea. To characterize nocturia pathophysiology associated with SDB in this population. To use telemonitoring data to define predictive factors of poor compliance.
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
- •Adult Patient with Chronic Heart Failure
- •Central Sleep Apnea requiring Adaptative Servo-Ventilation therapy
- •Patient is able to fully understand study information and signed informed consent
排除标准
- •Contra-indications to Adaptative Servo-Ventilation therapy
- •Respiratory Failure or Hypercapnia inconsistent with Adaptative Servo-Ventilation therapy
结局指标
主要结局
to define the phenotype of compliant or not compliant patients to sleep disordered breathing therapy using microneurography
时间窗: 12 months
Autonomic nervous system balance measure by microneurography
次要结局
- anxiety and nervous depression(12 months)
- Nocturia(24 months)
- sleep quality(24 months)
- Heart Failure status(24 months)
- sleep disordered breathing symptomatology(12 months)
- therapy compliance(24 months)
研究者
研究点 (3)
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