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) (FACE)

April 11, 2017 updated by: ResMed

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France, 94000
        • CHU Henri Mondor
      • Grenoble, France, 38000
        • Chu de Grenoble
      • Paris, France, 75018
        • CHU Bichat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Heart Failure patient eligible for adaptative servo-ventilation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to define the phenotype of compliant or not compliant patients to sleep disordered breathing therapy using microneurography
Time Frame: 12 months
Autonomic nervous system balance measure by microneurography
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ResMed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

February 2, 2015

First Submitted That Met QC Criteria

February 4, 2015

First Posted (Estimate)

February 5, 2015

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 11, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Face Pilot Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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