Actively Recruiting

Age: 40Years +
All Genders
NCT06861686

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

Led by Wissenschaftliches Institut Bethanien e.V · Updated on 2025-12-12

1800

Participants Needed

18

Research Sites

261 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient aged 40 years or older at the time of signed informed consent
  • Diagnosis of predominant obstructive sleep apnoea with a total apnea-hypopnea index of 5 or more events per hour based on a diagnostic sleep study
  • At least 70% of respiratory events classified as obstructive
  • Signed and dated written informed consent according to ICH-GCP and local regulations
Not Eligible

You will not qualify if you...

  • More than 30% central respiratory events during the diagnostic sleep study
  • Sleep apnea treatment within the last 12 months before study inclusion (positive airway pressure, mandibular advancement device, positional therapy)
  • Current or needed chronic use of any non-invasive positive pressure ventilation device
  • Participation in an interventional study or receiving investigational treatments
  • Significant disease or condition that may interfere with study procedures or participation
  • Patients unlikely to comply with protocol or complete the trial, including those with chronic alcohol or drug abuse or other reliability concerns

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 18 locations

1

Antwerp University Hospital

Antwerp, Antwerp, Belgium, B-2650

Not Yet Recruiting

2

UZ Leuven

Leuven, Vlaams-Brabant, Belgium, 3000

Actively Recruiting

3

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, Isère, France, 38043 Cedex 9

Not Yet Recruiting

4

Wissenschaftliches Institut Bethanien für Pneumologie e.V.

Solingen, Germany, 42699

Actively Recruiting

5

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

Alexandroupoli, Evros, Greece, 68100

Actively Recruiting

6

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

Athens, Greece

Not Yet Recruiting

7

University of Crete

Heraklion, Greece, 71500

Actively Recruiting

8

Respiratory Failure Unit, G. Papanikolaou Hospital

Thessaloniki, Greece

Not Yet Recruiting

9

Istituto Auxologico Italiano

Milan, Italy, 20149

Not Yet Recruiting

10

Istituti Clinici Scientifici Maugeri IRCCS

Pavia, Italy, 27100

Actively Recruiting

11

Institute of Tuberculosis and Lung Diseases

Warsaw, Masovian Voivodeship, Poland, 01-138

Actively Recruiting

12

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

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

Actively Recruiting

13

Hospital Beatriz Ângelo, Unidade Local de Saúde Loures-Odivelas

Loures, Portugal, 2674-514

Actively Recruiting

14

Clinica Somnolog

Bucharest, Romania

Actively Recruiting

15

University of Medicine and Pharmacy Dr. Victor Babes

Timișoara, Romania

Actively Recruiting

16

University Clinic of Respiratory and Allergic Diseases Golnik

Golnik, Slovenia, 4204

Actively Recruiting

17

Klinik für Pneumologie Universitätsspital Zürich

Zurich, Switzerland

Not Yet Recruiting

18

Ege University, Faculty of Medicine, Department of Respiratory Medicine

Izmir, Turkey (Türkiye)

Actively Recruiting

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Research Team

M

Marcel Treml, Dr.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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