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

Study Overview
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Brief Summary
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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.

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

Conditions
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Polysomnography, Heart Failure, Sleep Apnea Syndromes

Intervention / Treatment
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* Device: ventilatory polygraphic recordings


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart failure patients with sleep apnea syndrom<br>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). | Device: ventilatory polygraphic recordings<br>* Standard nocturnal in-home ventilatory polygraphic recordings were performed using an Embla device (Embla®, Broomfield, USA) and scored according to the AASM recommendations (RemLogic® software, Broomfield, USA).<br>* Other names: RemLogic® software, Broomfield, USA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea Hypopnea Index (AHI) | Standard nocturnal in-home ventilatory polygraphic recordings. The AHI is calculated only on nocturnal ECG analysis | At patient polygraphic recording | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AHI in subgroup patient with sinusal rhythm |  | At patient polygraphic recording | 
| AHI in subgroup with implanted pacemaker |  | At patient polygraphic recording | 
| AHI in subgroup with atrial fibrillation |  | At patient polygraphic recording | 
| AHI in subgroup with bundle branch block |  | At patient polygraphic recording | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic heart failure, Polysomnography, Sleep Apnea Syndromes, Electrocardiogram