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Taking people in PolandNo phase

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

Key facts

Who runs it
Wissenschaftliches Institut Bethanien e.V
Where
Warsaw, PolandSee the siteAlso in 10 other countries, 17 sites
Trial code
Status
Recruiting
People taking part
1,800 people, planned
Started
24 Mar 2025
Expected to end
31 Mar 2030
Type of study
Observational, 3 groups
Record updated
12 December 2025

Who can take part

Age
40 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Poland

Also in 10 other countries, 17 sites

  • Institute of Tuberculosis and Lung DiseasesWarsaw, PolandContact: Paweł Śliwiński, Prof. Dr.Taking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • weak treatment indication

    Patients with obstructive sleep apnoea (OSA) for whom OSA-specific treatment is generally not recommended according to the Baveno classification

  • intermediate treatment indication

    Patients with obstructive sleep apnoea (OSA) for whom OSA-specific treatment should be considered based on individual assessment according to the Baveno classification

  • strong treatment indication

    Patients with obstructive sleep apnoea (OSA) for whom OSA-specific treatment is generally recommended according to the Baveno classification

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Modified Baveno Classification of Obstructive Sleep Apnoea Based on Sleepiness and Cardiovascular Scores: A Prospective Observational Cohort Study
Record updated
12 December 2025