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

NCT02835638 | Completed DMC

• 1 other identifier: 2016-A01186-45
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 28

Brief Summary

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.

Conditions

Central Sleep Apnea; Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Adaptative Servo Ventilation DEVICE

the ASV treatment will be observed during this study on the patients included

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Patient affiliated to the national social security (beneficiary or assignee ).
• Patient being aware of the information form and signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (28)

CHU de Poitiers

Poitiers, New Aquitaine, 86021, France

Location

CHU d'Angers

Angers, 49933, France

Location

CH Antibes

Antibes, 06600, France

Location

Centre Hospitalier de Béziers

Béziers, 34500, France

Location

Hôpital de Chantilly Les Jockeys

Chantilly, 60631, France

Location

Hôpital Antoine Béclère

Clamart, 92140, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

CHU Dijon

Dijon, 21000, France

Location

CHU de Grenoble

Grenoble, 38043, France

Location

Groupe Hospitalier La Rochelle Ré Aunis

La Rochelle, 17019, France

Location

CH du Mans

Le Mans, 72100, France

Location

Clinique La Louvière

Lille, 59000, France

Location

Centre Hospitalier Régional Universitaire de Lille

Lille, 59037, France

Location

Hôpital Arnaud de Villeneuve CHU de Montpellier

Montpellier, 34295, France

Location

Groupe Hospitalier de la Région de Mulhouse et Sud Alsace

Mulhouse, 68070, France

Location

Hôpital Universitaire Saint Antoine

Paris, 75012, France

Location

Hôpital Bichat

Paris, 75018, France

Location

Hôpital de la Pitié Salpétrière

Paris, 75651, France

Location

CH Annecy Annecy

Pringy, 74374, France

Location

Hôpital Maison Blanche CHU de Reims

Reims, 51100, France

Location

Cabinet Libéral de Pneumologie

Rennes, 35700, France

Location

Centre VISAS

Saint-Etienne, 42055, France

Location

Groupe Hospitalier Public du Sud de l'Oise

Senlis, 60300, France

Location

Cabinet Libéral Selest

Strasbourg, 67000, France

Location

CHU de Strasbourg

Strasbourg, 67091, France

Location

Hôpital Larrey

Toulouse, 31059, France

Location

CHU de Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

Centre Hospitalier Bretagne Atlantique

Vannes, 56017, France

Location

Related Publications (1)

• Tamisier R, Philippe C, Prigent A, Charley-Monaca C, d'Ortho MP, Gentina T, Gagnadoux F, Launois C, Bironneau V, Mallet JP, Didi T, Guy T, Goutorbe F, Perrin C, Pontier-Marchandise S, Timsit JF, Pepin JL, Meurice JC; Etude de Cohorte Observationnelle Multicentrique Francaise de Patients Ayant un Syndrome d'Apnees du Sommeil Central ou Combine Avec SAS Central Predominant, Traites par Ventilation Auto-asservie Investigators. Change in Sleep Quality Associated With Adaptive Servoventilation for Central Sleep Apnea: Six-Month Follow-Up of the Multicenter Nationwide French "Etude de Cohorte Observationnelle Multicentrique Francaise de Patients Ayant un Syndrome d'Apnees du Sommeil Central ou Combine Avec SAS Central Predominant, Traites par Ventilation Auto-Asservie (FACIL-VAA)" Cohort. Chest. 2025 Apr;167(4):1204-1217. doi: 10.1016/j.chest.2024.12.015. Epub 2024 Dec 20.

  PMID: 39710250 DERIVED

Related 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.

MeSH Terms

Conditions

Sleep Apnea, Central

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 18, 2016
• Study Start: June 26, 2017
• Primary Completion: September 21, 2021
• Study Completion: December 16, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (28)