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)

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02356367

Acronym

FACE

Enrollment

Registered

2015-02-05

Start date

2016-05-31

Completion date

2017-05-31

Last updated

2017-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Sleep Apnea, Heart Failure

Keywords

telemonitoring, Adaptive servo-ventilation

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.

Interventions

OTHERtelemonitoring

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026