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A Modified Baveno Classification of Obstructive Sleep Apnoea Based on Sleepiness and Cardiovascular Scores | Clinical Trials | Clareo Health

RECRUITING

A Modified Baveno Classification of Obstructive Sleep Apnoea Based on Sleepiness and Cardiovascular Scores

A Modified Baveno Classification of Obstructive Sleep Apnoea Based on Sleepiness and Cardiovascular Scores: A Prospective Observational Cohort Study

NCT06861686•Wissenschaftliches Institut Bethanien e.V

View on ClinicalTrials.gov

Summary

The goal of this observational study is to evaluate a new classification system for obstructive sleep apnoea in patients with newly diagnosed obstructive sleep apnoea and monitor for long-term objective and subjective improvement.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

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)

Locations (18)

Antwerp University Hospital

Antwerp, Antwerp, Belgium

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, Isère, France

Wissenschaftliches Institut Bethanien für Pneumologie e.V.

Solingen, Germany

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

Alexandroupoli, Evros, Greece

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

Athens, Greece

University of Crete

Heraklion, Greece

Respiratory Failure Unit, G. Papanikolaou Hospital

Thessaloniki, Greece

Istituto Auxologico Italiano

Milan, Italy

Istituti Clinici Scientifici Maugeri IRCCS

Pavia, Italy

Key Dates

Start Date

March 24, 2025

Primary Completion Date

March 31, 2030

Completion Date

March 31, 2030

Last Updated

December 12, 2025

Enrollment

1,800

ESTIMATED participants

Conditions

Obstructive Sleep Apnea (OSA)

Contacts

Marcel Treml, Dr.

CONTACT

+49212636661 marcel.treml@klinik-bethanien.de

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Modified Baveno Classification of Obstructive Sleep Apnoea Based on Sleepiness and Cardiovascular Scores

Inclusion Criteria

Exclusion Criteria

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