Central Sleep Apnea Syndrome in Patients Whose EF is Above 45 Percent Clinical Trial
— FACIL-VAAOfficial 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
| Verified date | September 2022 |
| Source | Société Française de Recherche et de Médecine du Sommeil |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 520 |
| Est. completion date | December 31, 2025 |
| Est. primary completion date | September 21, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU d'Angers | Angers | |
| France | CH Antibes | Antibes | |
| France | Centre Hospitalier de Béziers | Béziers | |
| France | Hôpital de Chantilly Les Jockeys | Chantilly | |
| France | Hôpital Antoine Béclère | Clamart | |
| France | Hôpital Henri Mondor | Créteil | |
| France | CHU Dijon | Dijon | |
| France | CHU de Grenoble | Grenoble | |
| France | Groupe Hospitalier La Rochelle Ré Aunis | La Rochelle | |
| France | CH du Mans | Le Mans | |
| France | Centre Hospitalier Régional Universitaire de Lille | Lille | |
| France | Clinique La Louvière | Lille | |
| France | Hôpital Arnaud de Villeneuve CHU de Montpellier | Montpellier | |
| France | Groupe Hospitalier de la Région de Mulhouse et Sud Alsace | Mulhouse | |
| France | Hôpital Bichat | Paris | |
| France | Hôpital de la Pitié Salpétrière | Paris | |
| France | Hôpital Universitaire Saint Antoine | Paris | |
| France | CHU de Poitiers | Poitiers | Nouvelle Aquitaine |
| France | CH Annecy Annecy | Pringy | |
| France | Hôpital Maison Blanche CHU de Reims | Reims | |
| France | Cabinet Libéral de Pneumologie | Rennes | |
| France | Centre VISAS | Saint-Étienne | |
| France | Groupe Hospitalier Public du Sud de l'Oise | Senlis | |
| France | Cabinet Libéral Selest | Strasbourg | |
| France | CHU de Strasbourg | Strasbourg | |
| France | Hôpital Larrey | Toulouse | |
| France | CHU de Nancy | Vandœuvre-lès-Nancy | |
| France | Centre Hospitalier Bretagne Atlantique | Vannes |
| Lead Sponsor | Collaborator |
|---|---|
| Société Française de Recherche et de Médecine du Sommeil |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |