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Clinical Trials in Germany / NCT06861686
Recruiting Observational

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

NCT06861686 · tracked via the Priya Life Science Germany tracker
Sponsor
Wissenschaftliches Institut Bethanien e.V
Phase
Observational
Started
2025-03-24
Last updated
2025-12-12

Condition(s) studied

Obstructive Sleep Apnea (OSA)

Study 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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
Antwerp University Hospital Antwerp Antwerp Not Yet Recruiting
UZ Leuven Leuven Vlaams-Brabant Recruiting
Centre Hospitalier Universitaire Grenoble Alpes Grenoble Isère Not Yet Recruiting
Wissenschaftliches Institut Bethanien für Pneumologie e.V. Solingen Germany Recruiting
Department of Pulmonology, University General Hospital of Alexandroupolis, Medical School, Democritus University of Thrace Alexandroupoli Evros 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 Greece Recruiting
Respiratory Failure Unit, G. Papanikolaou Hospital Thessaloniki Greece Not Yet Recruiting
Istituto Auxologico Italiano Milan Italy Not Yet Recruiting
Istituti Clinici Scientifici Maugeri IRCCS Pavia Italy Recruiting
Institute of Tuberculosis and Lung Diseases Warsaw Masovian Voivodeship Recruiting
Unidade Local de Saúde de Gaia e Espinho ULSGE - Unidade de Patologia do Sons Vila Nova de Gaia Porto District Recruiting
Hospital Beatriz Ângelo, Unidade Local de Saúde Loures-Odivelas Loures 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 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

Other trials for the same condition

EURO-STIM Registry Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06861686 on ClinicalTrials.gov ↗ ← All trials in Germany