ECG Derived Respiration for Automated Screening of Sleep Disordered Breathing in Chronic Heart Failure Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Apnea Hypopnea Index (AHI)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •chronic heart failure
- •left ventricular ejection fraction \< 45%
- •New York Heart Association (NYHA) index ≥ 2
- •Sleep apnea syndrom confirmed by polysomnography
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Apnea Hypopnea Index (AHI)
Time Frame: At patient polygraphic recording
Standard nocturnal in-home ventilatory polygraphic recordings. The AHI is calculated only on nocturnal ECG analysis
Secondary Outcomes
- 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)