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

NCT ID: NCT02835638

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 520 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-26
• Study Completion Date: 2025-12-31

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 Syndrome in Patients Whose EF is Above 45 Percent

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Adaptative Servo Ventilation

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Société Française de Recherche et de Médecine du Sommeil

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Poitiers

Poitiers, Nouvelle-Aquitaine, 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

Clinique La Louvière

Lille, , France

Centre Hospitalier Régional Universitaire de Lille

Lille, , France

Hôpital Arnaud de Villeneuve CHU de Montpellier

Montpellier, , France

Groupe Hospitalier de la Région de Mulhouse et Sud Alsace

Mulhouse, , France

Hôpital Universitaire Saint Antoine

Paris, , France

Hôpital Bichat

Paris, , France

Hôpital de la Pitié Salpétrière

Paris, , France

CH Annecy Annecy

Pringy, , France

Hôpital Maison Blanche CHU de Reims

Reims, , France

Cabinet Libéral de Pneumologie

Rennes, , France

Centre VISAS

Saint-Etienne, , 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, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 39710250 (View on PubMed)

Related Links

http://www.resmed.com/us/en/consumer/newsandinformation/news-releases/2015/resmed-provides-update-on-phase-iv-serve-hf-study-of-adaptive-servo-ventilation-therapy.html

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.

Other Identifiers

2016-A01186-45

Identifier Type: -

Identifier Source: org_study_id