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French study tracks sleep quality in central apnea patients using smart ventilator

NCT ID NCT02835638

Knowledge-focused Sponsor: Société Française de Recherche et de Médecine du Sommeil Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 520 French adults with central or mixed sleep apnea to see how a treatment called adaptive servo-ventilation (ASV) improved their sleep quality. Participants used a breathing device that adjusts pressure in real time. The goal was to measure changes in sleep quality over time, not to test a cure or new drug.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

520 people

The number who actually took part.

Started

Jun 2017

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients With Central or Combined Sleep Apnea Syndrome (SAS) Out of Heart Failure (HF) With Altered Ejection Fraction, With a Predominant Central SAS.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

central sleep apnea syndrome complex sleep apnea diastolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Central sleep apnea Heart failure with preserved ejection fraction

Contacts and locations

Locations

  • CH Annecy Annecy

    Pringy, 74374, France

  • CH Antibes

    Antibes, 06600, France

  • CH du Mans

    Le Mans, 72100, France

  • CHU Dijon

    Dijon, 21000, France

  • CHU d'Angers

    Angers, 49933, France

  • CHU de Grenoble

    Grenoble, 38043, France

  • CHU de Nancy

    Vandœuvre-lès-Nancy, 54511, France

  • CHU de Poitiers

    Poitiers, New Aquitaine, 86021, France

  • CHU de Strasbourg

    Strasbourg, 67091, France

  • Cabinet Libéral Selest

    Strasbourg, 67000, France

  • Cabinet Libéral de Pneumologie

    Rennes, 35700, France

  • Centre Hospitalier Bretagne Atlantique

    Vannes, 56017, France

  • Centre Hospitalier Régional Universitaire de Lille

    Lille, 59037, France

  • Centre Hospitalier de Béziers

    Béziers, 34500, France

  • Centre VISAS

    Saint-Etienne, 42055, France

  • Clinique La Louvière

    Lille, 59000, France

  • Groupe Hospitalier La Rochelle Ré Aunis

    La Rochelle, 17019, France

  • Groupe Hospitalier Public du Sud de l'Oise

    Senlis, 60300, France

  • Groupe Hospitalier de la Région de Mulhouse et Sud Alsace

    Mulhouse, 68070, France

  • Hôpital Antoine Béclère

    Clamart, 92140, France

  • Hôpital Arnaud de Villeneuve CHU de Montpellier

    Montpellier, 34295, France

  • Hôpital Bichat

    Paris, 75018, France

  • Hôpital Henri Mondor

    Créteil, 94010, France

  • Hôpital Larrey

    Toulouse, 31059, France

  • Hôpital Maison Blanche CHU de Reims

    Reims, 51100, France

  • Hôpital Universitaire Saint Antoine

    Paris, 75012, France

  • Hôpital de Chantilly Les Jockeys

    Chantilly, 60631, France

  • Hôpital de la Pitié Salpétrière

    Paris, 75651, France

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