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

Launched by WISSENSCHAFTLICHES INSTITUT BETHANIEN E.V · Feb 28, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to classify obstructive sleep apnea (OSA), a condition where a person's breathing repeatedly stops and starts during sleep. The researchers want to see if this new classification, which takes into account how sleepy patients feel and their heart health, can help doctors better understand and treat OSA. The study will include adults aged 40 and older who have been diagnosed with OSA, specifically those whose breathing issues are mostly caused by blockages in the airway.

Eligible participants will need to provide written consent and will be monitored for both short-term and long-term improvements in their condition. It's important to note that individuals who have been treated for OSA in the past year, have certain other breathing issues, or have significant other health problems may not qualify for this study. As the trial is not yet recruiting, those interested should keep an eye out for when it opens, as it offers a chance to participate in important research that could improve understanding and treatment of sleep apnea.

Gender

ALL

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)