New classification for sleep apnea based on daytime sleepiness and heart risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will enroll adults aged 40 and older with newly diagnosed predominantly obstructive sleep apnea (AHI ≥5) at centers in Belgium and France. Investigators will apply a modified Baveno classification that combines measures of daytime sleepiness and cardiovascular risk, using diagnostic polysomnography or polygraphy per local standards. Participants will be followed over time for objective measures (repeat sleep testing) and subjective outcomes (sleepiness questionnaires and clinical cardiovascular events) without introducing experimental treatments. The aim is to determine whether the new classification correlates with long-term improvement and cardiovascular risk.

Why it matters

Who can join: the full rules

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)

Where it's running

• UZ Leuven
  Leuven, Vlaams-Brabant, Belgium Recruiting
• Wissenschaftliches Institut Bethanien für Pneumologie e.V.
  Solingen, Germany Recruiting
• Department of Pulmonology, University General Hospital of Alexandroupolis, Medical School, Democritus University of Thrace
  Alexandroupoli, Evros, Greece Recruiting
• University of Crete
  Heraklion, Greece Recruiting
• Istituti Clinici Scientifici Maugeri IRCCS
  Pavia, Italy Recruiting
• Institute of Tuberculosis and Lung Diseases
  Warsaw, Masovian Voivodeship, Poland Recruiting

Study contacts

• Principal investigator: Winfried J Randerath, Prof. Dr. — Wissenschaftliches Institut Bethanien für Pneumologie e.V.
• Study coordinator: Marcel Treml, Dr.
• Email: marcel.treml@klinik-bethanien.de
• Phone: +49212636661

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.