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

Société Française de Recherche et de Médecine du Sommeil

Status: Active, not recruiting

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

Treatments: Device: Adaptative Servo Ventilation

Study type: Observational

Funder types: Other

Identifiers

NCT02835638

2016-A01186-45

Details and patient eligibility

About

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.

Enrollment: 520 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.