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New sleep apnea classification could change how we treat it

NCT ID NCT06861686

Knowledge-focused Sponsor: Wissenschaftliches Institut Bethanien e.V Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at a new system for classifying obstructive sleep apnea (OSA) based on how sleepy patients feel and their heart health. Researchers will follow 1,800 adults newly diagnosed with OSA to see if this classification helps predict long-term improvements. The goal is to better understand which patients need more aggressive treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a better system for classifying sleep apnea, helping doctors tailor treatments more effectively.
What could go wrong
This is an observational study, not a treatment trial. It may not directly improve outcomes, and the new classification might not prove better than current methods.

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

About 1,800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Mar 2030

An estimate. End dates often move.

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 suspected obstructive sleep apnoea presenting for sleep medical evaluation

Ages

40 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 1. Adult patient ≥40 years at the time of signed informed consent 2. Diagnosis of predominant obstructive sleep apnoea with a total apnoea-hypopnoea index of ≥5 /h based on a diagnostic sleep study (polysomnography or polygraphy, as per local standard). Predominant obstructive sleep apnoea defined as ≥70% of respiratory events classified as obstructive. 3. Signed and dated written informed consent in accordance with ICH-GCP and applicable local regulations Exclusion criteria 1. \>30% central respiratory events (apnoeas and hypopnoeas) within the diagnostic sleep study 2. Established sleep apnoea treatment within the last 12 months before study inclusion (positive airway pressure, mandibular advancement device, positional therapy) 3. Use, or need for chronic use, of any non-invasive positive pressure ventilation device 4. Participation in an interventional study and/or receiving investigational treatment(s) 5. Significant disease or condition, which, in the opinion of the investigator, may interfere with study procedures or cause concern regarding the patient's ability to participate in the study 6. Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the patient an unreliable trial participant)

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome

As listed by the trial registrant

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

Obstructive sleep apnea (OSA)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Antwerp University Hospital

    NOT_YET_RECRUITING

    Antwerp, Antwerp, B-2650, Belgium

  • Centre Hospitalier Universitaire Grenoble Alpes

    NOT_YET_RECRUITING

    Grenoble, Isère, 38043 Cedex 9, France

  • Clinica Somnolog

    RECRUITING

    Bucharest, Romania

  • Department of Pulmonology, University General Hospital of Alexandroupolis, Medical School, Democritus University of Thrace

    RECRUITING

    Alexandroupoli, Evros, 68100, Greece

  • Division of Pulmonology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Medical School

    NOT_YET_RECRUITING

    Athens, Greece

  • Ege University, Faculty of Medicine, Department of Respiratory Medicine

    RECRUITING

    Izmir, Turkey (Türkiye)

  • Hospital Beatriz Ângelo, Unidade Local de Saúde Loures-Odivelas

    RECRUITING

    Loures, 2674-514, Portugal

  • Institute of Tuberculosis and Lung Diseases

    RECRUITING

    Warsaw, Masovian Voivodeship, 01-138, Poland

  • Istituti Clinici Scientifici Maugeri IRCCS

    RECRUITING

    Pavia, 27100, Italy

  • Istituto Auxologico Italiano

    NOT_YET_RECRUITING

    Milan, 20149, Italy

  • Klinik für Pneumologie Universitätsspital Zürich

    NOT_YET_RECRUITING

    Zurich, Switzerland

  • Respiratory Failure Unit, G. Papanikolaou Hospital

    NOT_YET_RECRUITING

    Thessaloniki, Greece

  • UZ Leuven

    RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

  • Unidade Local de Saúde de Gaia e Espinho ULSGE - Unidade de Patologia do Sons

    RECRUITING

    Vila Nova de Gaia, Porto District, 4434-502, Portugal

  • University Clinic of Respiratory and Allergic Diseases Golnik

    RECRUITING

    Golnik, 4204, Slovenia

  • University of Crete

    RECRUITING

    Heraklion, 71500, Greece

  • University of Medicine and Pharmacy Dr. Victor Babes

    RECRUITING

    Timișoara, Romania

  • Wissenschaftliches Institut Bethanien für Pneumologie e.V.

    RECRUITING

    Solingen, 42699, Germany

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