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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02116686
Other study ID # OBS2014
Secondary ID
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


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
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