Clinical trial NCT06861686: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea (OSA)
Lead sponsor: Wissenschaftliches Institut Bethanien e.V
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 1800
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected obstructive sleep apnoea presenting for sleep medical evaluation

Brief 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 criteria: 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 outcomes:
measure: Change in daytime sleepiness as measured by the Epworth Sleepiness Scale
timeFrame: From enrollment to the end of the individual observation period at 36 months
measure: Change in office systolic blood pressure
timeFrame: From enrollment to the end of the individual observation period at 36 months
Secondary outcomes:
measure: Change in office diastolic blood pressure
timeFrame: From enrollment to the end of the individual observation period at 36 months
measure: 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)
timeFrame: From enrollment to the end of the individual observation period at 36 months
measure: Average OSA treatment usage
timeFrame: From enrollment to the end of the individual observation period at 36 months
measure: Number of patients who discontinue OSA treatment
timeFrame: From enrollment to the end of the individual observation period at 36 months
measure: Change in Insomnia Severity Index total score
timeFrame: From enrollment to the end of the individual observation period at 36 months
measure: Change in subjective sleep length
timeFrame: From enrollment to the end of the individual observation period at 36 months
measure: Change in Fatigue Severity Scale mean score
timeFrame: From enrollment to the end of the individual observation period at 36 months
measure: Change in cognitive performance as assessed by the Montreal Cognitive Assessment (MoCA) total score
timeFrame: From enrollment to the end of the individual observation period at 36 months
measure: Change in average oxygen desaturation area as measured by overnight oximetry
timeFrame: From enrollment to the end of the individual observation period at 36 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
city: Antwerp
country: Belgium
facility: Antwerp University Hospital
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire Grenoble Alpes
state: Isère
city: Solingen
country: Germany
facility: Wissenschaftliches Institut Bethanien für Pneumologie e.V.
city: Athens
country: Greece
facility: Division of Pulmonology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Medical School
city: Heraklion
country: Greece
facility: University of Crete
city: Thessaloniki
country: Greece
facility: Respiratory Failure Unit, G. Papanikolaou Hospital
city: Milan
country: Italy
facility: Istituto Auxologico Italiano
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri IRCCS
city: Warsaw
country: Poland
facility: Institute of Tuberculosis and Lung Diseases
state: Mazovia
city: Vila Nova de Gaia
country: Portugal
facility: Unidade Local de Saúde de Gaia e Espinho ULSGE - Unidade de Patologia do Sons
state: Porto
city: Loures
country: Portugal
facility: Hospital Beatriz Ângelo, Unidade Local de Saúde Loures-Odivelas
city: Bucharest
country: Romania
facility: Clinica Somnolog
city: Timişoara
country: Romania
facility: University of Medicine and Pharmacy Dr. Victor Babes
city: Golnik
country: Slovenia
facility: University Clinic of Respiratory and Allergic Diseases Golnik
city: Zürich
country: Switzerland
facility: Klinik für Pneumologie Universitätsspital Zürich
city: Izmir
country: Turkey
facility: Ege University, Faculty of Medicine, Department of Respiratory Medicine
Study officials:
affiliation: Wissenschaftliches Institut Bethanien für Pneumologie e.V.
name: Winfried J Randerath, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: