A Modified Baveno Classification of Obstructive Sleep Apnoea Based on Sleepiness and Cardiovascular Scores
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- How often do I need to come in, and for how long each time?
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Contact the study team: see the registry record → Contacts and Locations
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- Who runs it
- Wissenschaftliches Institut Bethanien e.V
- Trial code
- NCT06861686
- Record updated
- 12 December 2025
- Original description
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.Read full original descriptionShow less
A Modified Baveno Classification of Obstructive Sleep Apnoea Based on Sleepiness and Cardiovascular Scores: A Prospective Observational Cohort Study
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.
Inclusion: 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: Established sleep apnoea treatment within the last 12 months before study inclusion (positive airway pressure, mandibular advancement device, positional therapy); 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); >30% central respiratory events (apnoeas and hypopnoeas) within the diagnostic sleep study; Use, or need for chronic use, of any non-invasive positive pressure ventilation device.