Central Sleep ApneaFACIL-VAANCT02835638
Quality of Sleep of Patients With Predominant Central Sleep Apnea Syndrome(SAS) Whose EF > 45% Treated by ASV
An observational study of Central Sleep Apnea and Heart Failure With Preserved Ejection Fraction, run by Société Française de Recherche et de Médecine du Sommeil at 28 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Sleep Apnea, Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Adaptative Servo Ventilation
- Type of treatment
- Medical device
- How many people
- 520 participants
- Where
- 28 sitesFrance
- Study dates
- 26 Jun 2017to 16 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 ).
Show all 10Show fewer
- 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.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
France28 sites
CHU d'Angers
Angers, 49933
CH Antibes
Antibes, 06600
Centre Hospitalier de Béziers
Béziers, 34500
Hôpital de Chantilly Les Jockeys
Chantilly, 60631
Hôpital Antoine Béclère
Clamart, 92140
Hôpital Henri Mondor
Créteil, 94010
CHU Dijon
Dijon, 21000
CHU de Grenoble
Grenoble, 38043
Groupe Hospitalier La Rochelle Ré Aunis
La Rochelle, 17019
CH du Mans
Le Mans, 72100
Clinique La Louvière
Lille, 59000
Centre Hospitalier Régional Universitaire de Lille
Lille, 59037
Hôpital Arnaud de Villeneuve CHU de Montpellier
Montpellier, 34295
Groupe Hospitalier de la Région de Mulhouse et Sud Alsace
Mulhouse, 68070
Hôpital Universitaire Saint Antoine
Paris, 75012
Hôpital Bichat
Paris, 75018
Hôpital de la Pitié Salpétrière
Paris, 75651
CHU de Poitiers
Poitiers, New Aquitaine, 86021
CH Annecy Annecy
Pringy, 74374
Hôpital Maison Blanche CHU de Reims
Reims, 51100
Cabinet Libéral de Pneumologie
Rennes, 35700
Centre VISAS
Saint-Etienne, 42055
Groupe Hospitalier Public du Sud de l'Oise
Senlis, 60300
Cabinet Libéral Selest
Strasbourg, 67000
CHU de Strasbourg
Strasbourg, 67091
Hôpital Larrey
Toulouse, 31059
CHU de Nancy
Vandœuvre-lès-Nancy, 54511
Centre Hospitalier Bretagne Atlantique
Vannes, 56017
About this study
Official title: 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.
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
- Being tested
- Adaptative Servo Ventilation
- Medical subject headings
- Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptative Servo VentilationDevice
the ASV treatment will be observed during this study on the patients included
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of sleep
assessment of the evolution of the sleep quality using the Pittsburgh Sleep Quality Index ( PSQI ) in all patients for any etiologies.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study start26 Jun 2017
- Primary completion21 Sep 2021
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société Française de Recherche et de Médecine du Sommeil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835638
- Sponsor's protocol ID
- 2016-A01186-45
- Acronym
- FACIL-VAA
- Status last verified
- Apr 2026
- First submitted
- 8 Jul 2016
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: oversight committee
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02835638
- Acronym / sponsor ID
- FACIL-VAA / 2016-A01186-45
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Société Française de Recherche et de Médecine du SommeilUniversity, hospital or other
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (10 listed)
- Patients with against -indication for the use of ASV :
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptative Servo Ventilationthe ASV treatment will be observed during this study on the patients included | Device | – |
Primary outcome
quality of sleep
Time frame: 6 months
assessment of the evolution of the sleep quality using the Pittsburgh Sleep Quality Index ( PSQI ) in all patients for any etiologies.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Derived from this study: PubMed 39710250Tamisier 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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. oversight committee
Related trials for Central Sleep Apnea
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Not yet recruitingObservational study
Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
Obstructive Sleep Apnea, Sleep Apnea, Obstructive
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Sleep Apnea and Heart Failure With Preserved Ejection Fraction, run by Société Française de Recherche et de Médecine du Sommeil at 28 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of sleep (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02835638, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.