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Completed

NCT Number: NCT02835638

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Poitiers, Poitiers, New Aquitaine, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adaptative Servo Ventilation

Device

the ASV treatment will be observed during this study on the patients included

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Société Française de Recherche et de Médecine du Sommeil

Other

Registry information

Official study title

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

Acronym: FACIL-VAA

Important dates

Study start
2017
Primary completion
2021
Study completion
2025
First posted
Jul 18, 2016
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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