What is this study trying to find out about obstructive sleep apnoea?

This study is evaluating a new way to classify obstructive sleep apnoea based on sleepiness and heart-related scores. It aims to understand how this classification relates to patient outcomes and treatment needs over time. The study is led by Wissenschaftliches Institut Bethanien e.V and focuses on adults with newly diagnosed obstructive sleep apnoea.

Who may be eligible for this obstructive sleep apnoea clinical trial?

Adults aged 40 years or older with a diagnosis of obstructive sleep apnoea having at least 5 apnea-hypopnea events per hour may be eligible. Both men and women can participate. Those who have used sleep apnoea treatments in the last year or have high central breathing event rates may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this obstructive sleep apnoea clinical trial?

Study-related care, including all study visits and assessments, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs related to travel or accommodation.

Actively Recruiting

Age: 40Years +

All Genders

ID06861686

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

Led by Wissenschaftliches Institut Bethanien e.V · Updated on 2025-12-12

1800

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a new classification system called the Modified Baveno Classification to better understand obstructive sleep apnoea OSA in adults newly diagnosed with this condition. The study aims to monitor long-term improvements in both objective and subjective measures related to OSA, including daytime sleepiness and cardiovascular health. This observational cohort study is led by Wissenschaftliches Institut Bethanien e.V and focuses on patients aged 40 years and older. Participants will be categorized into three groups based on the Baveno classification those for whom OSA-specific treatment is generally not recommended, those for whom treatment should be considered individually, and those for whom treatment is generally recommended. The study does not involve administering treatments but observes the patients over time according to their classification and treatment indications. During the study, participants will be followed for up to 36 months. Researchers will assess changes in daytime sleepiness using the Epworth Sleepiness Scale and monitor office blood pressure. Additional evaluations include cardiovascular events, treatment usage, insomnia severity, sleep length, fatigue, cognitive performance, and overnight oxygen levels. The study tracks these measures throughout the observation period to understand how the classification correlates with patient outcomes and treatment decisions.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adult patient aged 40 years or older at the time of signed informed consent
Diagnosis of predominant obstructive sleep apnoea with a total apnea-hypopnea index of 5 or more per hour based on a diagnostic sleep study
At least 70% of respiratory events classified as obstructive
Signed and dated written informed consent according to regulations

You will not qualify if you...

More than 30% central respiratory events within the diagnostic sleep study
Established sleep apnoea treatment within the last 12 months (positive airway pressure, mandibular device, positional therapy)
Use or need for chronic use of any non-invasive positive pressure ventilation device
Participation in an interventional study or receiving investigational treatments
Significant disease or condition that may interfere with study procedures or participation
Expected non-compliance or inability to complete the trial (e.g., chronic alcohol or drug abuse, or other conditions making the participant unreliable)

Research Team

Marcel Treml, Dr.

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