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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02116686

Enrollment

100

Registered

2014-04-17

Start date

2013-06-30

Completion date

2014-11-30

Last updated

2015-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Polysomnography, Sleep Apnea Syndromes

Keywords

chronic heart failure, Polysomnography, Sleep Apnea Syndromes, Electrocardiogram

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.

Interventions

DEVICEventilatory polygraphic recordings

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).

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026