Status:

RECRUITING

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

Lead Sponsor:

Wissenschaftliches Institut Bethanien e.V

Conditions:

Obstructive Sleep Apnea (OSA)

Eligibility:

All Genders

40+ years

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 objecti...

Eligibility Criteria

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)

Key Trial Info

Start Date :

March 24 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

March 31 2030

Estimated Enrollment :

1800 Patients enrolled

Trial Details

Trial ID

NCT06861686

Start Date

March 24 2025

End Date

March 31 2030

Last Update

December 12 2025

Active Locations (18)

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Page 1 of 5 (18 locations)

1

Antwerp University Hospital

Antwerp, Antwerp, Belgium, B-2650

2

UZ Leuven

Leuven, Vlaams-Brabant, Belgium, 3000

3

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, Isère, France, 38043 Cedex 9

4

Wissenschaftliches Institut Bethanien für Pneumologie e.V.

Solingen, Germany, 42699