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CompletedNCT02835638FACIL-VAAUpdated Apr 24, 2026

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

An observational study in Central Sleep Apnea and Heart Failure With Preserved Ejection Fraction, sponsored by Société Française de Recherche et de Médecine du Sommeil. Completed at 28 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Société Française de Recherche et de Médecine du Sommeil · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
520
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

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.

PSQI should decrease of minimum 1 point

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Conditions studied

  • Central Sleep Apnea
  • Heart Failure With Preserved Ejection Fraction

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In context

Sleep Apnea, Central

82 studies on the registry are indexed under Sleep Apnea, Central; 14 are open to participants now.

This study's enrollment of 520 is above the median of 125 across 30 observational studies indexed under Sleep Apnea, Central.

Browse Sleep Apnea, Central studies →

Lead sponsor

This is the only study on the registry with Société Française de Recherche et de Médecine du Sommeil as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
520 participants (actual)
Patient registry
No

Interventions

  • DeviceAdaptative Servo Ventilation

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

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What researchers measure

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.

    Time frame: 6 months

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Study locations

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

Publications

  • 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. PubMed 39710250 ↗

Individual participant data

Plan to share: Yes — oversight committee

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02835638
Lead sponsor
Société Française de Recherche et de Médecine du Sommeil
Responsible party
Sponsor
First posted
Jul 18, 2016
Start date
Jun 26, 2017
Primary completion
Sep 21, 2021
Completion
Dec 16, 2025
Last update
Apr 24, 2026

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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