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

NCT ID: NCT02116686

Last Updated: 2015-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure Sleep Apnea Syndromes Polysomnography

Keywords

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chronic heart failure Polysomnography Sleep Apnea Syndromes Electrocardiogram

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

ventilatory polygraphic recordings

Intervention Type 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).

Interventions

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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).

Intervention Type DEVICE

Other Intervention Names

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Embla device (Embla®, Broomfield, USA) RemLogic® software, Broomfield, USA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederic ROCHE, MD PhD

Role: STUDY_DIRECTOR

CHU de Saint-Etienne

Locations

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CHU de Grenoble

Grenoble, , France

Site Status

CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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OBS2014

Identifier Type: -

Identifier Source: org_study_id