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

ClinicalTrials.gov ID

NCT06861686

Lead Sponsor

Wissenschaftliches Institut Bethanien e.VOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

1,800Estimated

Last Update Posted

Dec 12, 2025Actual

Start Date

Mar 24, 2025Actual

Primary Completion Date

Mar 31, 2030Estimated

Completion Date

Mar 31, 2030Estimated

Official Title

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

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.

• Obstructive Sleep Apnea (OSA)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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)

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Wissenschaftliches Institut Bethanien e.VOTHER

lien.hermans@uzleuven.be+3216348308

izolthi@gmail.com00306932978636

e.perger@auxologico.it+393487727722

francesco.fanfulla@icsmaugeri.it+390382592010

oanadeleanu@gmail.com+40213356910/1415

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