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

Official title

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

Overview

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.

Primary outcome measures

• Change in daytime sleepiness as measured by the Epworth Sleepiness Scale [Time frame: From enrollment to the end of the individual observation period at 36 months]
• Change in office systolic blood pressure [Time frame: From enrollment to the end of the individual observation period at 36 months]

Secondary outcome measures (9)

• Change in office diastolic blood pressure [Time frame: From enrollment to the end of the individual observation period at 36 months]
• Cardiovascular events (MACE) occurring after study inclusion, including but not limited to myocardial infarction, stroke, hospitalisation for cardiovascular-related treatment (e.g. heart failure, arrhythmia) [Time frame: From enrollment to the end of the individual observation period at 36 months]
• Average OSA treatment usage [Time frame: From enrollment to the end of the individual observation period at 36 months]
• Number of patients who discontinue OSA treatment [Time frame: From enrollment to the end of the individual observation period at 36 months]
• Change in Insomnia Severity Index total score [Time frame: From enrollment to the end of the individual observation period at 36 months]
• Change in subjective sleep length [Time frame: From enrollment to the end of the individual observation period at 36 months]
• Change in Fatigue Severity Scale mean score [Time frame: From enrollment to the end of the individual observation period at 36 months]
• Change in cognitive performance as assessed by the Montreal Cognitive Assessment (MoCA) total score [Time frame: From enrollment to the end of the individual observation period at 36 months]
• Change in average oxygen desaturation area as measured by overnight oximetry [Time frame: From enrollment to the end of the individual observation period at 36 months]

Eligibility criteria

Inclusion criteria

• Adult patient ≥40 years at the time of signed informed consent
• 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.
• Signed and dated written informed consent in accordance with ICH-GCP and applicable local regulations

Exclusion criteria

• >30% central respiratory events (apnoeas and hypopnoeas) within the diagnostic sleep study
• Established sleep apnoea treatment within the last 12 months before study inclusion (positive airway pressure, mandibular advancement device, positional therapy)
• Use, or need for chronic use, of any non-invasive positive pressure ventilation device
• Participation in an interventional study and/or receiving investigational treatment(s)
• 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
• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Greece · 4 centers

• Department of Pulmonology, University General Hospital of Alexandroupolis, Medical School, — Alexandroupoli
• Division of Pulmonology, Department of Clinical Therapeutics, National and Kapodistrian Un — Athens
• University of Crete — Heraklion
• Respiratory Failure Unit, G. Papanikolaou Hospital — Thessaloniki

Belgium · 2 centers

• Antwerp University Hospital — Antwerp
• UZ Leuven — Leuven

Italy · 2 centers

• Istituto Auxologico Italiano — Milan
• Istituti Clinici Scientifici Maugeri IRCCS — Pavia

Portugal · 2 centers

• Unidade Local de Saúde de Gaia e Espinho ULSGE - Unidade de Patologia do Sons — Vila Nova de Gaia
• Hospital Beatriz Ângelo, Unidade Local de Saúde Loures-Odivelas — Loures

Romania · 2 centers

• Clinica Somnolog — Bucharest
• University of Medicine and Pharmacy Dr. Victor Babes — Timișoara

France · 1 center

• Centre Hospitalier Universitaire Grenoble Alpes — Grenoble

Germany · 1 center

• Wissenschaftliches Institut Bethanien für Pneumologie e.V. — Solingen

Poland · 1 center

• Institute of Tuberculosis and Lung Diseases — Warsaw

Slovenia · 1 center

• University Clinic of Respiratory and Allergic Diseases Golnik — Golnik

Switzerland · 1 center

• Klinik für Pneumologie Universitätsspital Zürich — Zurich

Turkey (Türkiye) · 1 center

• Ege University, Faculty of Medicine, Department of Respiratory Medicine — Izmir

Identifiers

NCT: NCT06861686 · WI_24-1422

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗