A Modified Baveno Classification of Obstructive Sleep Apnoea Based on Sleepiness and Cardiovascular Scores
NCT ID: NCT06861686
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1800 participants
OBSERVATIONAL
2025-03-24
2030-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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weak treatment indication
Patients with obstructive sleep apnoea (OSA) for whom OSA-specific treatment is generally not recommended according to the Baveno classification
No interventions assigned to this group
intermediate treatment indication
Patients with obstructive sleep apnoea (OSA) for whom OSA-specific treatment should be considered based on individual assessment according to the Baveno classification
No interventions assigned to this group
strong treatment indication
Patients with obstructive sleep apnoea (OSA) for whom OSA-specific treatment is generally recommended according to the Baveno classification
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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)
40 Years
ALL
No
Sponsors
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Wissenschaftliches Institut Bethanien e.V
OTHER
Responsible Party
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Principal Investigators
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Winfried J Randerath, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Wissenschaftliches Institut Bethanien für Pneumologie e.V.
Locations
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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
Institute of Tuberculosis and Lung Diseases
Warsaw, Masovian Voivodeship, Poland
Unidade Local de Saúde de Gaia e Espinho ULSGE - Unidade de Patologia do Sons
Vila Nova de Gaia, Porto District, Portugal
Hospital Beatriz Ângelo, Unidade Local de Saúde Loures-Odivelas
Loures, , Portugal
Clinica Somnolog
Bucharest, , Romania
University of Medicine and Pharmacy Dr. Victor Babes
Timișoara, , Romania
University Clinic of Respiratory and Allergic Diseases Golnik
Golnik, , Slovenia
Klinik für Pneumologie Universitätsspital Zürich
Zurich, , Switzerland
Ege University, Faculty of Medicine, Department of Respiratory Medicine
Izmir, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WI_24-1422
Identifier Type: -
Identifier Source: org_study_id
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