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

Société Française de Recherche et de Médecine du Sommeil56 sites in 1 country520 target enrollmentJune 26, 2017

ConditionsCentral Sleep Apnea Syndrome in Patients Whose EF is Above 45 Percent Central Sleep Apnea Heart Failure With Preserved Ejection Fraction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Central Sleep Apnea Syndrome in Patients Whose EF is Above 45 Percent
Sponsor: Société Française de Recherche et de Médecine du Sommeil
Enrollment: 520
Locations: 56
Primary Endpoint: quality of sleep
Status: Completed
Last Updated: 8 days ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

June 26, 2017

End Date

December 16, 2025

Last Updated

8 days ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Société Française de Recherche et de Médecine du Sommeil

Responsible Party

Sponsor

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.