Quality of Sleep of Patients With Predominant Central Sleep Apnea Syndrome(SAS) Whose EF > 45% Tr… (NCT02835638) | Clinical Trial Compass
CompletedNot Applicable
Quality of Sleep of Patients With Predominant Central Sleep Apnea Syndrome(SAS) Whose EF > 45% Treated by ASV
France520 participantsStarted 2017-06-26
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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% obstruc…