French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS, AirCurve 10CS): Predictive Factors of Poor Compliance (FACE)

ResMed

Overview

The purpose of this study is to determine the predictive factors of poor compliance to sleep disordered breathing therapy in chronic heart failure patients treated for central sleep apnea. To characterize nocturia pathophysiology associated with SDB in this population. To use telemonitoring data to define predictive factors of poor compliance.

Study Type

OBSERVATIONAL

Conditions

Central Sleep Apnea Heart Failure

Interventions

telemonitoringOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult Patient with Chronic Heart Failure * Central Sleep Apnea requiring Adaptative Servo-Ventilation therapy * Patient is able to fully understand study information and signed informed consent Exclusion Criteria: * Contra-indications to Adaptative Servo-Ventilation therapy * Respiratory Failure or Hypercapnia inconsistent with Adaptative Servo-Ventilation therapy

Locations (3)

CHU Henri Mondor

Créteil, France

CHU de Grenoble

Grenoble, France

CHU Bichat

Paris, France

Outcomes

Primary Outcomes

to define the phenotype of compliant or not compliant patients to sleep disordered breathing therapy using microneurography

Autonomic nervous system balance measure by microneurography

Time frame: 12 months

Secondary Outcomes

anxiety and nervous depression

using Spielberger questionnaire and Beck's Depression Inventory

Time frame: 12 months

sleep disordered breathing symptomatology

using Epworth sleepiness scale and Oxford Sleep Resistance Test

Time frame: 12 months

Nocturia

evaluated by number of urination per night, diuresis, plasmatic dosage of Atrial Natriuretic peptide, Brain natriuretic peptide, Antidiuretic hormone

Time frame: 24 months

sleep quality

evaluated by Pittsburgh Sleep Quality Index; minnesota living with heart failure questionnaire; actimetry; home polysomnography

Time frame: 24 months

Heart Failure status

evaluated by echocardiography, New York Heart Association functional classification; Electrocardiography

Time frame: 24 months

therapy compliance

evaluated by Morisky Medication Adherence Scale and with telemonitoring data

Time frame: 24 months

Data from ClinicalTrials.gov

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