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OpenTrials
Completed

NCT Number: NCT02116686

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

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.

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Key information

Conditions

Heart Failure Apnea Cardiovascular Diseases Dyssomnias Heart Diseases Nervous System Diseases Polysomnography Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Grenoble, Grenoble, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ventilatory polygraphic recordings

Device

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).

Other names: Embla device (Embla®, Broomfield, USA), RemLogic® software, Broomfield, USA

Primary outcomes

  1. 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

  1. AHI in subgroup patient with sinusal rhythm

    Time frame: At patient polygraphic recording

  2. AHI in subgroup with implanted pacemaker

    Time frame: At patient polygraphic recording

  3. AHI in subgroup with atrial fibrillation

    Time frame: At patient polygraphic recording

  4. AHI in subgroup with bundle branch block

    Time frame: At patient polygraphic recording

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 17, 2014
Registry last updated
Mar 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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