NCT02835638Completed
Quality of Sleep of Patients With Predominant Central Sleep Apnea Syndrome(SAS) Whose EF > 45% Treated by ASV
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
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Observational
- Enrollment
- 520 (actual)
- First submitted
- 8 Jul 2016
- Start date
- 26 Jun 2017
- Primary completion date
- 21 Sept 2021
- Lead sponsor
- Société Française de Recherche et de Médecine du Sommeil
- Diseases
- Heart failure
- NCT number
- NCT02835638
What you commit to
- Study type: Observational
- Participants enrolled: 520
- From 26 Jun 2017 to the primary completion date, 21 Sept 2021
- 28 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Lab values
- Patients with a diagnosis of systolic heart failure (LVEF ≤45 %) with a predominant central SAS ( \> 50% central events ).
Other
- Patients with predominant obstructive sleep apnea (OSA) (\> 85% obstructive events ).
- Standardized central SAS by the Continuous Positive Airway Pressure
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU d Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| CH Antibes Coordinator of this site? Confirm its status | Antibes | France | Unknown status |
| Centre Hospitalier de Béziers Coordinator of this site? Confirm its status | Béziers | France | Unknown status |
| Hôpital de Chantilly Les Jockeys Coordinator of this site? Confirm its status | Chantilly | France | Unknown status |
| Hopital Antoine Beclere Coordinator of this site? Confirm its status | Clamart | France | Unknown status |
| Hopital Henri Mondor Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| CHU Dijon Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| CHU de Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Groupe Hospitalier La Rochelle-Ré-Aunis Coordinator of this site? Confirm its status | La Rochelle | France | Unknown status |
| CH du Mans Coordinator of this site? Confirm its status | Le Mans | France | Unknown status |
| Clinique La Louvière Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Centre Hospitalier Regional Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Hôpital Arnaud de Villeneuve CHU de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Groupe Hospitalier de la Région de Mulhouse et Sud Alsace Coordinator of this site? Confirm its status | Mulhouse | France | Unknown status |
| Hôpital de la Pitié-Salpêtrière Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Bichat Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Universitaire Saint Antoine Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| CH Annecy Annecy Coordinator of this site? Confirm its status | Pringy | France | Unknown status |
| Hôpital Maison Blanche CHU de Reims Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| Cabinet Libéral de Pneumologie Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| Centre VISAS Coordinator of this site? Confirm its status | Saint-Etienne | France | Unknown status |
| Groupe Hospitalier Public du Sud de l'Oise Coordinator of this site? Confirm its status | Senlis | France | Unknown status |
| CHU de Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| Cabinet Libéral Selest Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| Hopital Larrey Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| CHU de Nancy Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
| Centre Hospitalier Bretagne Atlantique Coordinator of this site? Confirm its status | Vannes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.