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

NCT02116686 | Completed

• 1 other identifier: OBS2014
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure; Sleep Apnea Syndromes; Polysomnography

Keywords

chronic heart failure; Polysomnography; Sleep Apnea Syndromes; Electrocardiogram

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

Heart failure patients with sleep apnea syndrom

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

Interventions

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).

Also known as: Embla device (Embla®, Broomfield, USA), RemLogic® software, Broomfield, USA

Heart failure patients with sleep apnea syndrom

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heart failure patients with sleep apnea syndrom

You may qualify if:

• chronic heart failure
• left ventricular ejection fraction \< 45%
• New York Heart Association (NYHA) index ≥ 2
• Sleep apnea syndrom confirmed by polysomnography

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (2)

CHU de Grenoble

Grenoble, 38000, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Heart Failure; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Frederic ROCHE, MD PhD

  CHU de Saint-Etienne

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 17, 2014
• Study Start: June 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 31, 2015

Record last verified: 2015-03

Locations

FR (2)