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

Completed

• Conditions: Sleep Apnea Syndromes; Polysomnography; Heart Failure
• Interventions: Device: ventilatory polygraphic recordings

• Registration Number: NCT02116686
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-04-10
• Study First Submitted QC: 2014-04-16
• Study First Posted: 2014-04-17
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart failure patients with sleep apnea syndrom	ventilatory polygraphic recordings	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).

Primary Outcome Measures

Name	Time	Method
Apnea Hypopnea Index (AHI)	At patient polygraphic recording	Standard nocturnal in-home ventilatory polygraphic recordings. The AHI is calculated only on nocturnal ECG analysis

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

CHU de Saint-Etienne; 🇫🇷 Saint-etienne, France

CHU de Grenoble; 🇫🇷 Grenoble, France