Clinical trial NCT02835638: Quality of Sleep of Patients With Predominant Central Sleep Apnea Syndrome(SAS) Whose EF > 45% Treated by ASV
Official 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Central Sleep Apnea Syndrome in Patients Whose EF is Above 45 Percent
Lead sponsor: Société Française de Recherche et de Médecine du Sommeil
Sponsor class: OTHER
First posted: 2016-07-18
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients With Central or Combined Sleep Apnea Syndrome (SAS) Out of Heart Failure (HF) With Altered Ejection Fraction, With a Predominant Central SAS.

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.


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.

Primary outcomes:
measure: quality of sleep
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU de Poitiers
state: Nouvelle Aquitaine
city: Angers
country: France
facility: CHU d'Angers
city: Antibes
country: France
facility: CH Antibes
city: Béziers
country: France
facility: Centre Hospitalier de Béziers
city: Chantilly
country: France
facility: Hôpital de Chantilly Les Jockeys
city: Clamart
country: France
facility: Hôpital Antoine Béclère
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Dijon
country: France
facility: CHU Dijon
city: Grenoble
country: France
facility: CHU de Grenoble
city: La Rochelle
country: France
facility: Groupe Hospitalier La Rochelle Ré Aunis
city: Le Mans
country: France
facility: CH du Mans
city: Lille
country: France
facility: Clinique La Louvière
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve CHU de Montpellier
city: Mulhouse
country: France
facility: Groupe Hospitalier de la Région de Mulhouse et Sud Alsace
city: Paris
country: France
facility: Hôpital Universitaire Saint Antoine
city: Paris
country: France
facility: Hôpital Bichat
city: Paris
country: France
facility: Hôpital de la Pitié Salpétrière
city: Pringy
country: France
facility: CH Annecy Annecy
city: Reims
country: France
facility: Hôpital Maison Blanche CHU de Reims
city: Rennes
country: France
facility: Cabinet Libéral de Pneumologie
city: Saint-Étienne
country: France
facility: Centre VISAS
city: Senlis
country: France
facility: Groupe Hospitalier Public du Sud de l'Oise
city: Strasbourg
country: France
facility: Cabinet Libéral Selest
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: Hôpital Larrey
city: Vandœuvre-lès-Nancy
country: France
facility: CHU de Nancy
city: Vannes
country: France
facility: Centre Hospitalier Bretagne Atlantique
Study officials:
References: