ECG Derived Respiration for Automated Screening of Sleep Disordered Breathing in Chronic Heart Failure Patients

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Sleep Apnea Syndromes; Polysomnography; Heart Failure

Treatments: Device: ventilatory polygraphic recordings

Study type: Observational

Funder types: Other

Identifiers

NCT02116686

OBS2014

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Acute myocarditis or pericarditis during the 6 last months
• Valvular disease
• Pregnancy

Trial design

100 participants in 1 patient group

Heart failure patients with sleep apnea syndrom

Description:

For heart failure patients, a standard nocturnal in-home ventilatory polygraphic recordings were performed using an Embla device (Embla®, Broomfield, USA) and scored according to the America Academy of Sleep Medicine (AASM) recommendations (RemLogic® software, Broomfield, USA).

Treatment:

Device: ventilatory polygraphic recordings