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)

Withdrawn

• Conditions: Central Sleep Apnea; Heart Failure

• Registration Number: NCT02356367
• Lead Sponsor: ResMed

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-02
• Study First Submitted QC: 2015-02-04
• Study First Posted: 2015-02-05
• Study Start: 2016-05
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-11
• Last Update Posted: 2017-04-12
• Primary Completion: 2017-05
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to define the phenotype of compliant or not compliant patients to sleep disordered breathing therapy using microneurography	12 months	Autonomic nervous system balance measure by microneurography

Secondary Outcome Measures

Name	Time	Method
anxiety and nervous depression	12 months	using Spielberger questionnaire and Beck's Depression Inventory
Nocturia	24 months	evaluated by number of urination per night, diuresis, plasmatic dosage of Atrial Natriuretic peptide, Brain natriuretic peptide, Antidiuretic hormone
sleep quality	24 months	evaluated by Pittsburgh Sleep Quality Index; minnesota living with heart failure questionnaire; actimetry; home polysomnography
Heart Failure status	24 months	evaluated by echocardiography, New York Heart Association functional classification; Electrocardiography
sleep disordered breathing symptomatology	12 months	using Epworth sleepiness scale and Oxford Sleep Resistance Test
therapy compliance	24 months	evaluated by Morisky Medication Adherence Scale and with telemonitoring data

Trial Locations

Locations (3)

CHU de Grenoble; 🇫🇷 Grenoble, France

CHU Bichat; 🇫🇷 Paris, France

CHU Henri Mondor; 🇫🇷 Créteil, France