ECG Derived Respiration for Automated Screening of Sleep Disordered Breathing in Chronic Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Apnea Hypopnea Index (AHI)
研究概览
简要总结
The prevalence of sleep disordered breathing (SDB) reaches more than 50% in chronic heart failure patients (CHF). The main consequence is an increase risk of fatal and non-fatal cardiovascular events. A treatment by continuous positive airway pressure (CPAP) or adaptative servo-ventilation (ASV) reduces this risk. Nevertheless, 75% of severe SDB cases remains undiagnosed and untreated especially due to cost and time delay for polysomnography examination which is the gold standard for SDB diagnosis. Indeed, alternative methods are developed. Some methods, based on nocturnal ECG analysis showed promising results but they are not validated and adapted for cardiac population. Thus, the goal of present study is to test the accuracy of ECG derived respiration signal to screen SDB in a CHF population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •chronic heart failure
- •left ventricular ejection fraction < 45%
- •New York Heart Association (NYHA) index ≥ 2
- •Sleep apnea syndrom confirmed by polysomnography
排除标准
- •Chronic Obstructive Pulmonary Disease with maximal Respiratory Volume < 50%
- •Resting oxygen saturation < 90%
- •Continuous Positive Airway Pressure (CPAP) or Adaptive Servo-Ventilation treatment
- •Life expectancy < 1 year for other medical reasons than heart failure
- •Cardiac surgery
- •Percutaneous transluminal coronary angioplasty
- •Unstable angora during the 6 last months
- •Implantation of a pacemaker or a defibrillator during the 6 last months
- •Cerebrovascular accident or Transient Ischemic Attack during the 3 last months
- •Restless legs syndrome
- •Acute myocarditis or pericarditis during the 6 last months
- •Valvular disease
- •Pregnancy
结局指标
主要结局
Apnea Hypopnea Index (AHI)
时间窗: At patient polygraphic recording
Standard nocturnal in-home ventilatory polygraphic recordings. The AHI is calculated only on nocturnal ECG analysis
次要结局
- AHI in subgroup with atrial fibrillation(At patient polygraphic recording)
- AHI in subgroup with bundle branch block(At patient polygraphic recording)
- AHI in subgroup patient with sinusal rhythm(At patient polygraphic recording)
- AHI in subgroup with implanted pacemaker(At patient polygraphic recording)