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
1 other identifier
observational
N/A
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2016
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2015
CompletedFirst Posted
Study publicly available on registry
February 5, 2015
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedApril 12, 2017
April 1, 2017
1 year
February 2, 2015
April 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
to define the phenotype of compliant or not compliant patients to sleep disordered breathing therapy using microneurography
Autonomic nervous system balance measure by microneurography
12 months
Secondary Outcomes (6)
anxiety and nervous depression
12 months
sleep disordered breathing symptomatology
12 months
Nocturia
24 months
sleep quality
24 months
Heart Failure status
24 months
- +1 more secondary outcomes
Interventions
Eligibility Criteria
Heart Failure patient eligible for adaptative servo-ventilation
You may qualify if:
- 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
You may not qualify if:
- Contra-indications to Adaptative Servo-Ventilation therapy
- Respiratory Failure or Hypercapnia inconsistent with Adaptative Servo-Ventilation therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ResMedlead
Study Sites (3)
CHU Henri Mondor
Créteil, 94000, France
CHU de Grenoble
Grenoble, 38000, France
CHU Bichat
Paris, 75018, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2015
First Posted
February 5, 2015
Study Start
May 1, 2016
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
April 12, 2017
Record last verified: 2017-04