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

Active, not recruiting

• Conditions: Central Sleep Apnea Syndrome in Patients Whose EF is Above 45 Percent

• Registration Number: NCT02835638
• Lead Sponsor: Société Française de Recherche et de Médecine du Sommeil

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-13
• Study First Posted: 2016-07-18
• Study Start: 2017-06-26
• Primary Completion: 2021-09-21
• Status Verified: 2022-09
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-14
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 520

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
quality of sleep	6 months	assessment of the evolution of the sleep quality using the Pittsburgh Sleep Quality Index ( PSQI ) in all patients for any etiologies.

Trial Locations

Locations (28)

Hôpital Henri Mondor; 🇫🇷 Créteil, France

CHU de Poitiers; 🇫🇷 Poitiers, Nouvelle Aquitaine, France

CHU de Grenoble; 🇫🇷 Grenoble, France

Centre Hospitalier de Béziers; 🇫🇷 Béziers, France

CHU d'Angers; 🇫🇷 Angers, France

CH Antibes; 🇫🇷 Antibes, France

Hôpital Antoine Béclère; 🇫🇷 Clamart, France

Hôpital de Chantilly Les Jockeys; 🇫🇷 Chantilly, France

CHU Dijon; 🇫🇷 Dijon, 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 de la Pitié Salpétrière; 🇫🇷 Paris, France

Hôpital Bichat; 🇫🇷 Paris, France

CH Annecy Annecy; 🇫🇷 Pringy, France

Hôpital Universitaire Saint Antoine; 🇫🇷 Paris, France

Centre VISAS; 🇫🇷 Saint-Étienne, France

Hôpital Maison Blanche CHU de Reims; 🇫🇷 Reims, France

Cabinet Libéral de Pneumologie; 🇫🇷 Rennes, 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