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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116686
• Other study ID #: OBS2014
• Status: Completed
• Phase: N/A
• First received: April 10, 2014
• Last updated: March 30, 2015
• Start date: June 2013
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection AuthorityFrance: Institutional Ethical Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Heart Failure
• Polysomnography
• Sleep Apnea Syndromes

Intervention

Device:
• ventilatory 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).

Locations

Country	Name	City	State
France	CHU de Grenoble	Grenoble
France	CHU de Saint-Etienne	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea Hypopnea Index (AHI)	Standard nocturnal in-home ventilatory polygraphic recordings. The AHI is calculated only on nocturnal ECG analysis	At patient polygraphic recording	No
Secondary	AHI in subgroup patient with sinusal rhythm		At patient polygraphic recording	No
Secondary	AHI in subgroup with implanted pacemaker		At patient polygraphic recording	No
Secondary	AHI in subgroup with atrial fibrillation		At patient polygraphic recording	No
Secondary	AHI in subgroup with bundle branch block		At patient polygraphic recording	No