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

NCT06861686 | Recruiting

• 1 other identifier: WI_24-1422
• Study Type: observational
• Target: 1,800
• Locations: 11 countries
• Sites: 18

Brief 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.

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (2)

• Change in daytime sleepiness as measured by the Epworth Sleepiness Scale

  The Epworth Sleepiness Scale total score ranges from 0-24. Higher values represent a larger extent of daytime sleepiness

  From enrollment to the end of the individual observation period at 36 months

• Change in office systolic blood pressure

  From enrollment to the end of the individual observation period at 36 months

Secondary Outcomes (9)

• Change in office diastolic blood pressure

  From enrollment to the end of the individual observation period at 36 months

• Cardiovascular events (MACE) occurring after study inclusion, including but not limited to myocardial infarction, stroke, hospitalisation for cardiovascular-related treatment (e.g. heart failure, arrhythmia)

  From enrollment to the end of the individual observation period at 36 months

• Average OSA treatment usage

  From enrollment to the end of the individual observation period at 36 months

• Number of patients who discontinue OSA treatment

  From enrollment to the end of the individual observation period at 36 months

• Change in Insomnia Severity Index total score

  From enrollment to the end of the individual observation period at 36 months

Study Arms (3)

weak treatment indication

Patients with obstructive sleep apnoea (OSA) for whom OSA-specific treatment is generally not recommended according to the Baveno classification

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

strong treatment indication

Patients with obstructive sleep apnoea (OSA) for whom OSA-specific treatment is generally recommended according to the Baveno classification

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected obstructive sleep apnoea presenting for sleep medical evaluation

You may qualify if:

• Adult patient ≥40 years at the time of signed informed consent
• 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.
• Signed and dated written informed consent in accordance with ICH-GCP and applicable local regulations

You may not qualify if:

• \>30% central respiratory events (apnoeas and hypopnoeas) within the diagnostic sleep study
• Use, or need for chronic use, of any non-invasive positive pressure ventilation device
• Participation in an interventional study and/or receiving investigational treatment(s)
• 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
• 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)

Sponsors & Collaborators

• Wissenschaftliches Institut Bethanien e.V: lead

Study Sites (18)

Antwerp University Hospital

Antwerp, Antwerp, B-2650, Belgium

NOT YET RECRUITING

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, Isère, 38043 Cedex 9, France

NOT YET RECRUITING

Wissenschaftliches Institut Bethanien für Pneumologie e.V.

Solingen, 42699, Germany

RECRUITING

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

Alexandroupoli, Evros, 68100, Greece

RECRUITING

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

Athens, Greece

NOT YET RECRUITING

University of Crete

Heraklion, 71500, Greece

RECRUITING

Respiratory Failure Unit, G. Papanikolaou Hospital

Thessaloniki, Greece

NOT YET RECRUITING

Istituto Auxologico Italiano

Milan, 20149, Italy

NOT YET RECRUITING

Istituti Clinici Scientifici Maugeri IRCCS

Pavia, 27100, Italy

RECRUITING

Institute of Tuberculosis and Lung Diseases

Warsaw, Masovian Voivodeship, 01-138, Poland

RECRUITING

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

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

RECRUITING

Hospital Beatriz Ângelo, Unidade Local de Saúde Loures-Odivelas

Loures, 2674-514, Portugal

RECRUITING

Clinica Somnolog

Bucharest, Romania

RECRUITING

University of Medicine and Pharmacy Dr. Victor Babes

Timișoara, Romania

RECRUITING

University Clinic of Respiratory and Allergic Diseases Golnik

Golnik, 4204, Slovenia

RECRUITING

Klinik für Pneumologie Universitätsspital Zürich

Zurich, Switzerland

NOT YET RECRUITING

Ege University, Faculty of Medicine, Department of Respiratory Medicine

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Winfried J Randerath, Prof. Dr.

  Wissenschaftliches Institut Bethanien für Pneumologie e.V.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcel Treml, Dr.

CONTACT

+49212636661; marcel.treml@klinik-bethanien.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 6, 2025
• Study Start: March 24, 2025
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2030
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

IT (2); GR (4); TU (1); CH (1); SL (1); FR (1); DE (1); PL (1); BE (2); RO (2); PT (2)