New way to group people with newly diagnosed obstructive sleep apnoea
Evaluates a new classification of obstructive sleep apnoea, following newly diagnosed patients over time.
Key facts
- Who runs it
- Wissenschaftliches Institut Bethanien e.V
- Where
- Zurich, SwitzerlandSee the siteAlso in 10 other countries, 17 sites
- Trial code
- Registry title
- A Modified Baveno Classification of Obstructive Sleep Apnoea Based on Sleepiness and Cardiovascular Scores
- 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
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 or older with newly diagnosed obstructive sleep apnoea. It tests a new way to group the disease and follows people over time.
- Age
- 40 years or older
- Sex
- All sexes
- Disease stage
- Mainly obstructive sleep apnoea, with an apnoea-hypopnoea index of ≥5 /h on a sleep study. At least 70% of breathing events must be obstructive.
- Earlier treatment
- No sleep apnoea treatment in the last 12 months, such as positive airway pressure, a mandibular advancement device or positional therapy.
Main reasons for not taking part
- More than 30% central breathing events in the sleep study
- Use of, or need for long-term use of, a non-invasive positive pressure breathing device
- Taking part in an interventional study or getting an investigational treatment
- A serious disease that could get in the way of the study, in the doctor's view
- Not expected to follow the study plan, for example chronic alcohol or drug abuse
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 Switzerland
Also in 10 other countries, 17 sites
- Klinik für Pneumologie, Universitätsspital ZürichZurich, SwitzerlandContact: Esther I Schwarz, Prof. Dr.Not yet recruiting
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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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
- Plain-language title
- New way to group people with newly diagnosed obstructive sleep apnoeaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 12 December 2025