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)

Heart Failure Clinical Trial

— FACE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02356367
• Other study ID #: Face Pilot Study
• Status: Withdrawn
• Phase: N/A
• First received: February 2, 2015
• Last updated: April 11, 2017
• Start date: May 2016
• Est. completion date: May 2017

Study information

• Verified date: April 2017
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Central Sleep Apnea
• Heart Failure
• Sleep Apnea Syndromes
• Sleep Apnea, Central

Intervention

Other:
• telemonitoring

Locations

Country	Name	City	State
France	CHU Henri Mondor	Créteil
France	CHU de Grenoble	Grenoble
France	CHU Bichat	Paris

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

France, 

Outcome

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