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NCT02835638Completed

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

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

Source: ClinicalTrials.gov · Last updated 24 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
520 (actual)
First submitted
8 Jul 2016
Start date
26 Jun 2017
Primary completion date
21 Sept 2021
Lead sponsor
Société Française de Recherche et de Médecine du Sommeil
NCT number
NCT02835638

What you commit to

  • Study type: Observational
  • Participants enrolled: 520
  • From 26 Jun 2017 to the primary completion date, 21 Sept 2021
  • 28 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Lab values

  • Patients with a diagnosis of systolic heart failure (LVEF ≤45 %) with a predominant central SAS ( \> 50% central events ).

Other

  • Patients with predominant obstructive sleep apnea (OSA) (\> 85% obstructive events ).
  • Standardized central SAS by the Continuous Positive Airway Pressure
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (28)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU d Angers
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AngersFranceUnknown status
CH Antibes
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AntibesFranceUnknown status
Centre Hospitalier de Béziers
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BéziersFranceUnknown status
Hôpital de Chantilly Les Jockeys
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ChantillyFranceUnknown status
Hopital Antoine Beclere
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ClamartFranceUnknown status
Hopital Henri Mondor
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CréteilFranceUnknown status
CHU Dijon
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DijonFranceUnknown status
CHU de Grenoble
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GrenobleFranceUnknown status
Groupe Hospitalier La Rochelle-Ré-Aunis
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La RochelleFranceUnknown status
CH du Mans
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Le MansFranceUnknown status
Clinique La Louvière
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LilleFranceUnknown status
Centre Hospitalier Regional Universitaire de Lille
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LilleFranceUnknown status
Hôpital Arnaud de Villeneuve CHU de Montpellier
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MontpellierFranceUnknown status
Groupe Hospitalier de la Région de Mulhouse et Sud Alsace
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MulhouseFranceUnknown status
Hôpital de la Pitié-Salpêtrière
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ParisFranceUnknown status
Hôpital Bichat
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ParisFranceUnknown status
Hôpital Universitaire Saint Antoine
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ParisFranceUnknown status
CHU de Poitiers
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PoitiersFranceUnknown status
CH Annecy Annecy
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PringyFranceUnknown status
Hôpital Maison Blanche CHU de Reims
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ReimsFranceUnknown status
Cabinet Libéral de Pneumologie
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RennesFranceUnknown status
Centre VISAS
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Saint-EtienneFranceUnknown status
Groupe Hospitalier Public du Sud de l'Oise
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SenlisFranceUnknown status
CHU de Strasbourg
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StrasbourgFranceUnknown status
Cabinet Libéral Selest
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StrasbourgFranceUnknown status
Hopital Larrey
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ToulouseFranceUnknown status
CHU de Nancy
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Vandœuvre-lès-NancyFranceUnknown status
Centre Hospitalier Bretagne Atlantique
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VannesFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.