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

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

We will test whether combining daytime sleepiness and cardiovascular risk scores can better predict long-term outcomes for adults newly diagnosed with obstructive sleep apnea.

Quick facts

• Study type: Observational
• Enrollment: 1800 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Wissenschaftliches Institut Bethanien e.V (Academic / other)
• Locations: 18 sites (Antwerp, Antwerp and 17 other locations)
• Trial ID: NCT06861686 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 40 years or older with newly diagnosed predominantly obstructive sleep apnea (AHI ≥5) who have not received sleep apnea treatment in the past 12 months and have fewer than 30% central events are ideal candidates.

Not a fit: Patients with primarily central sleep apnea (>30% central events), those already treated for sleep apnea within the last year, or adults under 40 are unlikely to benefit from this classification.

Why it matters

Potential benefit: If successful, the classification could help clinicians identify patients at higher cardiovascular risk and tailor monitoring or treatment intensity accordingly.

How similar studies have performed: Similar approaches combining sleepiness and cardiovascular risk have been proposed, but they remain relatively untested in large prospective cohorts.

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)

Where this trial is running

Antwerp, Antwerp and 17 other locations

• Antwerp University Hospital — Antwerp, Antwerp, Belgium (Not_yet_recruiting)
• UZ Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
• Centre Hospitalier Universitaire Grenoble Alpes — Grenoble, Isère, France (Not_yet_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)
• Division of Pulmonology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Medical School — Athens, Greece (Not_yet_recruiting)
• University of Crete — Heraklion, Greece (Recruiting)
• Respiratory Failure Unit, G. Papanikolaou Hospital — Thessaloniki, Greece (Not_yet_recruiting)
• Istituto Auxologico Italiano — Milan, Italy (Not_yet_recruiting)
• Istituti Clinici Scientifici Maugeri IRCCS — Pavia, Italy (Recruiting)
• Institute of Tuberculosis and Lung Diseases — Warsaw, Masovian Voivodeship, Poland (Recruiting)
• Unidade Local de Saúde de Gaia e Espinho ULSGE - Unidade de Patologia do Sons — Vila Nova de Gaia, Porto District, Portugal (Recruiting)
• Hospital Beatriz Ângelo, Unidade Local de Saúde Loures-Odivelas — Loures, Portugal (Recruiting)
• Clinica Somnolog — Bucharest, Romania (Recruiting)
• University of Medicine and Pharmacy Dr. Victor Babes — Timișoara, Romania (Recruiting)
• University Clinic of Respiratory and Allergic Diseases Golnik — Golnik, Slovenia (Recruiting)
• Klinik für Pneumologie Universitätsspital Zürich — Zurich, Switzerland (Not_yet_recruiting)
• Ege University, Faculty of Medicine, Department of Respiratory Medicine — Izmir, Turkey (Türkiye) (Recruiting)

Study contacts

• Principal investigator: Winfried J Randerath, Prof. Dr. — Wissenschaftliches Institut Bethanien für Pneumologie e.V.
• Study coordinator: Marcel Treml, Dr.

Conditions Obstructive Sleep Apnea