NCT02835638CompletedNot Applicable
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 enrollmentStarted: June 26, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 520
- Locations
- 56
- Primary Endpoint
- quality of sleep
Study 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
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.
PSQI should decrease of minimum 1 point
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
quality of sleep
Time Frame: 6 months
assessment of the evolution of the sleep quality using the Pittsburgh Sleep Quality Index ( PSQI ) in all patients for any etiologies.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (56)
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