Quality of Sleep of Patients With Predominant Central Sleep Apnea Syndrome(SAS) Whose EF > 45% Treated by ASV (FACIL-VAA)

Observational Multicenter Cohort Study of French Patients With a Central or Combined Syndrome of Sleep Apnea With a Predominant Central SAS Treated by Adaptive Servo-Ventilation

The main goal of this French multicenter observational cohort study is to prospectively collect data assessing the impact of the Adaptative Servo-Ventilation treatment on the quality of sleep of patients with central or combined sleep apnea syndrome (SAS) out of Heart Failure (HF) with altered ejection fraction, with a predominant central SAS.

Study Overview

• Status: Active, not recruiting
• Conditions: Central Sleep Apnea Syndrome in Patients Whose EF is Above 45 Percent
• Intervention / Treatment: Device: Adaptative Servo Ventilation

• Study Type: Observational
• Enrollment (Actual): 520

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • CHU d'Angers
  • Antibes, France, 06600
    • CH Antibes
  • Béziers, France, 34500
    • Centre Hospitalier de Beziers
  • Chantilly, France, 60631
    • Hôpital de Chantilly Les Jockeys
  • Clamart, France, 92140
    • Hopital Antoine Beclere
  • Créteil, France, 94010
    • Hopital Henri Mondor
  • Dijon, France, 21000
    • CHU Dijon
  • Grenoble, France, 38043
    • CHU de GRENOBLE
  • La Rochelle, France, 17019
    • Groupe Hospitalier La Rochelle Ré Aunis
  • Le Mans, France, 72100
    • CH du Mans
  • Lille, France, 59037
    • Centre Hospitalier Regional Universitaire de Lille
  • Lille, France, 59000
    • Clinique La Louvière
  • Montpellier, France, 34295
    • Hôpital Arnaud de Villeneuve CHU de Montpellier
  • Mulhouse, France, 68070
    • Groupe hospitalier de la région de Mulhouse et Sud Alsace
  • Paris, France, 75018
    • Hopital Bichat
  • Paris, France, 75651
    • Hopital de la Pitie Salpetriere
  • Paris, France, 75012
    • Hôpital Universitaire Saint Antoine
  • Pringy, France, 74374
    • CH Annecy Annecy
  • Reims, France, 51100
    • Hôpital Maison Blanche CHU de Reims
  • Rennes, France, 35700
    • Cabinet Libéral de Pneumologie
  • Saint-Étienne, France, 42055
    • Centre VISAS
  • Senlis, France, 60300
    • Groupe Hospitalier Public du Sud de l'Oise
  • Strasbourg, France, 67091
    • CHU de Strasbourg
  • Strasbourg, France, 67000
    • Cabinet Libéral Selest
  • Toulouse, France, 31059
    • Hôpital Larrey
  • Vandœuvre-lès-Nancy, France, 54511
    • Chu de Nancy
  • Vannes, France, 56017
    • Centre Hospitalier Bretagne Atlantique
  • Nouvelle Aquitaine
    • Poitiers, Nouvelle Aquitaine, France, 86021
      • CHU de Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients With Central or Combined Sleep Apnea Syndrome (SAS) Out of Heart Failure (HF) With Altered Ejection Fraction, With a Predominant Central SAS.

Description

Inclusion Criteria:

• Patient over 18 years

• Naive patient to treatment with positive pressure with AHIc > 15 requiring the establishment of an ASV to a central or combined SAS without any systolic HF (LVEF ≤ 45%) with predominant central SAS.

  • OR Patient with a predominant obstructive SAS ( ≤ 50% central event ) whose Continuous Positive Airway Pressure treatment (CPAP) does not allow adequate control of the central events: treated for at least 1 month CPAP with a residual central apnea hypopnea index greater than or equal to 10 events per hour (AHI global> 15, which AHIc ≥ 10) pressure to control obstructive events ( IAHo <5 ) controlled by polygraphy or polysomnography with a pressure test <10 cm H2O.
• Before inclusion, for patients who have previously been treated with CPAP, a PSG diagnosis will be made after a period of wash-out of CPAP of a 1-week period.
• Patient affiliated to the national social security (beneficiary or assignee ).
• Patient being aware of the information form and signed informed consent.

Exclusion Criteria:

• Patients with against -indication for the use of ASV :

  • History of massive epistaxis.
  • Diseases related to barotrauma particularly pneumothorax and pneumo- mediastinum.
  • Suspicions of meningeal gaps or trauma history of the prior stage of the skull base.
  • Shortness of breath or hypercapnia deemed incompatible by the doctor with the ASV treatment.
• Patients with predominant obstructive sleep apnea (OSA) (> 85% obstructive events ).
• Standardized central SAS by the Continuous Positive Airway Pressure
• Patients with a diagnosis of systolic heart failure (LVEF ≤45 %) with a predominant central SAS ( > 50% central events ).
• Person deprived of liberty by judicial or administrative decision, person under a legal protection measure (pregnant or lactating women, patients under guardianship)
• Lack of signature for the information form and the informed consent form.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of sleep	assessment of the evolution of the sleep quality using the Pittsburgh Sleep Quality Index ( PSQI ) in all patients for any etiologies.	6 months

Collaborators and Investigators

• Sponsor: Société Française de Recherche et de Médecine du Sommeil

Publications and helpful links

Helpful Links

• Description of the previous study SERVE-HF that included only altered LVEF patients. The SERVE-HF's population is the one the FACIL-VAA study is avoiding.

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2017
• Primary Completion (Actual): September 21, 2021
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: July 8, 2016
• First Submitted That Met QC Criteria: July 13, 2016
• First Posted (Estimate): July 18, 2016

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Syndrome; Apnea; Sleep Apnea, Central
• Other Study ID Numbers: 2016-A01186-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: oversight committee