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

December 11, 2025 updated by: Wissenschaftliches Institut Bethanien e.V

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Antwerp
      • Antwerp, Antwerp, Belgium, B-2650
        • Not yet recruiting
        • Antwerp University Hospital
        • Contact:
        • Principal Investigator:
          • Johan Verbraecken, Prof. Dr.
        • Sub-Investigator:
          • Verena Iven, PhD
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Contact:
        • Principal Investigator:
          • Dries Testelmans, Prof. Dr.
        • Sub-Investigator:
          • Alexandros Kalkanis, Prof. Dr.
  • France
    • Isère
      • Grenoble, Isère, France, 38043 Cedex 9
        • Not yet recruiting
        • Centre Hospitalier Universitaire Grenoble Alpes
        • Contact:
        • Principal Investigator:
          • Renaud Tamisier, Prof. Dr.
        • Sub-Investigator:
          • Jean-Louis Pépin, Dr.
        • Sub-Investigator:
          • Sébastien Baillieul, Dr.
  • Germany
      • Solingen, Germany, 42699
        • Recruiting
        • Wissenschaftliches Institut Bethanien für Pneumologie e.V.
        • Contact:
        • Principal Investigator:
          • Winfried J Randerath, Prof. Dr.
        • Sub-Investigator:
          • Sandhya Matthes, Dr.
  • Greece
      • Athens, Greece
        • Not yet recruiting
        • Division of Pulmonology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Medical School
        • Contact:
        • Principal Investigator:
          • Georgia Trakada, Prof. Dr.
      • Heraklion, Greece, 71500
        • Recruiting
        • University of Crete
        • Contact:
        • Principal Investigator:
          • Sofia E Schiza, Prof. Dr.
        • Sub-Investigator:
          • Izolde Bouloukaki, Dr.
      • Thessaloniki, Greece
        • Not yet recruiting
        • Respiratory Failure Unit, G. Papanikolaou Hospital
        • Contact:
        • Principal Investigator:
          • Athanasia Pataka, Prof. Dr.
    • Evros
      • Alexandroupoli, Evros, Greece, 68100
        • Recruiting
        • Department of Pulmonology, University General Hospital of Alexandroupolis, Medical School, Democritus University of Thrace
        • Contact:
        • Principal Investigator:
          • Paschalis Steiropoulos, Prof. Dr.
  • Italy
      • Milan, Italy, 20149
        • Not yet recruiting
        • Istituto Auxologico Italiano
        • Contact:
        • Principal Investigator:
          • Carolina Lombardi, Prof. Dr.
        • Sub-Investigator:
          • Gianfranco Parati, Prof. Dr.
      • Pavia, Italy, 27100
        • Recruiting
        • Istituti Clinici Scientifici Maugeri IRCCS
        • Contact:
        • Principal Investigator:
          • Francesco Fanfulla, Dr.
        • Sub-Investigator:
          • Carlo Perretti, Dr.
  • Poland
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 01-138
        • Recruiting
        • Institute of Tuberculosis and Lung Diseases
        • Contact:
        • Principal Investigator:
          • Paweł Śliwiński, Prof. Dr.
        • Sub-Investigator:
          • Adam Hołubek, Dr.
        • Sub-Investigator:
          • Damian Korzybski, Dr.
        • Sub-Investigator:
          • Malwina Sołtysiak, Dr.
  • Portugal
      • Loures, Portugal, 2674-514
        • Recruiting
        • Hospital Beatriz Ângelo, Unidade Local de Saúde Loures-Odivelas
        • Contact:
        • Principal Investigator:
          • Margarida Aguiar, Dr.
        • Sub-Investigator:
          • Margarida Barata, Dr.
    • Porto District
      • Vila Nova de Gaia, Porto District, Portugal, 4434-502
        • Recruiting
        • Unidade Local de Saúde de Gaia e Espinho ULSGE - Unidade de Patologia do Sons
        • Contact:
        • Principal Investigator:
          • Daniela Ferreira, Dr.
        • Sub-Investigator:
          • Daniela Machado, Dr.
  • Romania
      • Bucharest, Romania
        • Recruiting
        • Clinica Somnolog
        • Contact:
        • Principal Investigator:
          • Oana Claudia Deleanu, Dr.
        • Sub-Investigator:
          • Corina Borcea, Dr.
        • Sub-Investigator:
          • Andreea Petcu, Dr.
        • Sub-Investigator:
          • Razvan Lungu, Dr.
        • Sub-Investigator:
          • Valentin Cosei, Dr.
      • Timișoara, Romania
        • Recruiting
        • University of Medicine and Pharmacy Dr. Victor Babes
        • Contact:
  • Slovenia
      • Golnik, Slovenia, 4204
        • Recruiting
        • University Clinic of Respiratory and Allergic Diseases Golnik
        • Contact:
        • Principal Investigator:
          • Kristina Ziherl, MD
        • Sub-Investigator:
          • Irena Šarc, MD
  • Switzerland
      • Zurich, Switzerland
        • Not yet recruiting
        • Klinik für Pneumologie Universitätsspital Zürich
        • Contact:
        • Principal Investigator:
          • Esther I Schwarz, Prof. Dr.
        • Sub-Investigator:
          • Lara Benning, Dr. med.
  • Turkey (Türkiye)
      • Izmir, Turkey (Türkiye)
        • Recruiting
        • Ege University, Faculty of Medicine, Department of Respiratory Medicine
        • Contact:
        • Principal Investigator:
          • Özen K Basoglu, Prof. Dr.
        • Sub-Investigator:
          • Mehmet S Tasbakan, Prof. Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with suspected obstructive sleep apnoea presenting for sleep medical evaluation

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in daytime sleepiness as measured by the Epworth Sleepiness Scale
Time Frame: From enrollment to the end of the individual observation period at 36 months
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
Time Frame: From enrollment to the end of the individual observation period at 36 months
From enrollment to the end of the individual observation period at 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in office diastolic blood pressure
Time Frame: From enrollment to the end of the individual observation period at 36 months
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)
Time Frame: From enrollment to the end of the individual observation period at 36 months
From enrollment to the end of the individual observation period at 36 months
Average OSA treatment usage
Time Frame: From enrollment to the end of the individual observation period at 36 months
Average usage of the prescribed treatment for obstructive sleep apnea, measured as hours per day, derived from therapy device data
From enrollment to the end of the individual observation period at 36 months
Number of patients who discontinue OSA treatment
Time Frame: From enrollment to the end of the individual observation period at 36 months
From enrollment to the end of the individual observation period at 36 months
Change in Insomnia Severity Index total score
Time Frame: From enrollment to the end of the individual observation period at 36 months
The Insomnia Severity Index (ISI) total score ranges from 0-28. Higher scores represent a larger extent of insomnia-related symptoms. Scores of 15 and above are indicative of clinical insomnia.
From enrollment to the end of the individual observation period at 36 months
Change in subjective sleep length
Time Frame: From enrollment to the end of the individual observation period at 36 months
Subjective sleep length as assessed via personal interview, measured in hours per night
From enrollment to the end of the individual observation period at 36 months
Change in Fatigue Severity Scale mean score
Time Frame: From enrollment to the end of the individual observation period at 36 months
The Fatigue Severity Scale (FSS) mean score ranges from 0-7, with higher values indicating a larger extent of fatigue.
From enrollment to the end of the individual observation period at 36 months
Change in cognitive performance as assessed by the Montreal Cognitive Assessment (MoCA) total score
Time Frame: From enrollment to the end of the individual observation period at 36 months
The Montreal Cognitive Assessment (MoCA) total score ranges from 0-30. A higher score represents a better cognitive performance. A result of 26 or higher is considered normal.
From enrollment to the end of the individual observation period at 36 months
Change in average oxygen desaturation area as measured by overnight oximetry
Time Frame: From enrollment to the end of the individual observation period at 36 months
The average oxygen desaturation area (unit: s*%) is automatically calculated from the oximetry signal of a single night poly(somno)graphy. Higher values indicate a larger extent of hypoxic burden.
From enrollment to the end of the individual observation period at 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wissenschaftliches Institut Bethanien e.V

Investigators

  • Principal Investigator: Winfried J Randerath, Prof. Dr., Wissenschaftliches Institut Bethanien für Pneumologie e.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2025

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

March 31, 2030

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 6, 2025

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WI_24-1422

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obstructive Sleep Apnea (OSA)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe