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RECRUITINGOBSERVATIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Inclusion criteria 1. Adult patient ≥40 years at the time of signed willing to sign a consent form 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 willing to sign a consent form 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Locations (18)

Antwerp University Hospital
Antwerp, Antwerp, Belgium
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, Isère, France
Wissenschaftliches Institut Bethanien für Pneumologie e.V.
Solingen, Germany
Department of Pulmonology, University General Hospital of Alexandroupolis, Medical School, Democritus University of Thrace
Alexandroupoli, Evros, Greece
Division of Pulmonology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Medical School
Athens, Greece
University of Crete
Heraklion, Greece
Respiratory Failure Unit, G. Papanikolaou Hospital
Thessaloniki, Greece
Istituto Auxologico Italiano
Milan, Italy
Istituti Clinici Scientifici Maugeri IRCCS
Pavia, Italy
Institute of Tuberculosis and Lung Diseases
Warsaw, Masovian Voivodeship, Poland
Unidade Local de Saúde de Gaia e Espinho ULSGE - Unidade de Patologia do Sons
Vila Nova de Gaia, Porto District, Portugal
Hospital Beatriz Ângelo, Unidade Local de Saúde Loures-Odivelas
Loures, Portugal
Clinica Somnolog
Bucharest, Romania
University of Medicine and Pharmacy Dr. Victor Babes
Timișoara, Romania
University Clinic of Respiratory and Allergic Diseases Golnik
Golnik, Slovenia
Klinik für Pneumologie Universitätsspital Zürich
Zurich, Switzerland
Ege University, Faculty of Medicine, Department of Respiratory Medicine
Izmir, Turkey (Türkiye)