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

Официальное название

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

Обзор

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.

Первичные конечные точки

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

Вторичные конечные точки (9)

• Change in office diastolic blood pressure [Срок оценки: 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) [Срок оценки: From enrollment to the end of the individual observation period at 36 months]
• Average OSA treatment usage [Срок оценки: From enrollment to the end of the individual observation period at 36 months]
• Number of patients who discontinue OSA treatment [Срок оценки: From enrollment to the end of the individual observation period at 36 months]
• Change in Insomnia Severity Index total score [Срок оценки: From enrollment to the end of the individual observation period at 36 months]
• Change in subjective sleep length [Срок оценки: From enrollment to the end of the individual observation period at 36 months]
• Change in Fatigue Severity Scale mean score [Срок оценки: 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 [Срок оценки: From enrollment to the end of the individual observation period at 36 months]
• Change in average oxygen desaturation area as measured by overnight oximetry [Срок оценки: From enrollment to the end of the individual observation period at 36 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• >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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Греция · 4 центра

• 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

Бельгия · 2 центра

• Antwerp University Hospital — Antwerp
• UZ Leuven — Leuven

Италия · 2 центра

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

Португалия · 2 центра

• 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

Румыния · 2 центра

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

Франция · 1 центр

• Centre Hospitalier Universitaire Grenoble Alpes — Grenoble

Германия · 1 центр

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

Польша · 1 центр

• Institute of Tuberculosis and Lung Diseases — Warsaw

Словения · 1 центр

• University Clinic of Respiratory and Allergic Diseases Golnik — Golnik

Швейцария · 1 центр

• Klinik für Pneumologie Universitätsspital Zürich — Zurich

Turkey (Türkiye) · 1 центр

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

Идентификаторы

NCT: NCT06861686 · WI_24-1422

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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