Actively Recruiting
A Modified Baveno Classification of Obstructive Sleep Apnoea Based on Sleepiness and Cardiovascular Scores: A Prospective Observational Cohort Study
Led by Wissenschaftliches Institut Bethanien e.V · Updated on 2025-12-12
1800
Participants Needed
18
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new classification system called the Modified Baveno Classification to better understand obstructive sleep apnoea (OSA) in adults newly diagnosed with this condition. The study aims to monitor long-term improvements in both objective and subjective measures related to OSA, including daytime sleepiness and cardiovascular health. This observational cohort study is led by Wissenschaftliches Institut Bethanien e.V and focuses on patients aged 40 years and older. Participants will be categorized into three groups based on the Baveno classification: those for whom OSA-specific treatment is generally not recommended, those for whom treatment should be considered individually, and those for whom treatment is generally recommended. The study does not involve administering treatments but observes the patients over time according to their classification and treatment indications. During the study, participants will be followed for up to 36 months. Researchers will assess changes in daytime sleepiness using the Epworth Sleepiness Scale and monitor office blood pressure. Additional evaluations include cardiovascular events, treatment usage, insomnia severity, sleep length, fatigue, cognitive performance, and overnight oxygen levels. The study tracks these measures throughout the observation period to understand how the classification correlates with patient outcomes and treatment decisions.
CONDITIONS
Brief Title
A Modified Baveno Classification of Obstructive Sleep Apnoea Based on Sleepiness and Cardiovascular Scores
Who Can Participate
Eligibility Criteria
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 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 regulations
You will not qualify if you...
- More than 30% central respiratory events within the diagnostic sleep study
- Established sleep apnoea treatment within the last 12 months (positive airway pressure, mandibular device, positional therapy)
- Use or need for 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
- Expected non-compliance or inability to complete the trial (e.g., chronic alcohol or drug abuse, or other conditions making the participant unreliable)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months
Participants with obstructive sleep apnoea are observed over time to assess changes in sleepiness, blood pressure, cardiovascular events, and other health measures.
Regular visits throughout the observation period
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
Research Team
M
Marcel Treml, Dr.
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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