Clinical Trials in Italy / NCT06861686
Recruiting
Observational
A Modified Baveno Classification of Obstructive Sleep Apnoea Based on Sleepiness and Cardiovascular Scores
NCT06861686 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Obstructive Sleep Apnea (OSA)
Study 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.
Eligibility
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)
Primary outcome measure(s)
- Change in daytime sleepiness as measured by the Epworth Sleepiness Scale — From enrollment to the end of the individual observation period at 36 months
The Epworth Sleepiness Scale total score ranges from 0-24. Higher values represent a larger extent of daytime sleepiness - Change in office systolic blood pressure — From enrollment to the end of the individual observation period at 36 months
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| Antwerp University Hospital | Antwerp | Antwerp | Not Yet Recruiting |
| UZ Leuven | Leuven | Vlaams-Brabant | Recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes | Grenoble | Isère | 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 | 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 | Recruiting |
| Unidade Local de Saúde de Gaia e Espinho ULSGE - Unidade de Patologia do Sons | Vila Nova de Gaia | Porto District | 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 |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06861686 on ClinicalTrials.gov ↗ ← All trials in Italy