Obstructive Sleep Apnea (OSA)NCT06861686
A Modified Baveno Classification of Obstructive Sleep Apnoea Based on Sleepiness and Cardiovascular Scores
An observational study of Obstructive Sleep Apnea (OSA), run by Wissenschaftliches Institut Bethanien e.V at 18 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- How many people
- 1,800 participants
- Where
- 18 sitesin 11 countries
- Study dates
- 24 Mar 2025to 31 Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected obstructive sleep apnoea presenting for sleep medical evaluation
Who may be able to join
- Adult patient ≥40 years at the time of signed informed consent
- 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.
- Signed and dated written informed consent in accordance with ICH-GCP and applicable local regulations
Who cannot join
- >30% central respiratory events (apnoeas and hypopnoeas) within the diagnostic sleep study
- Established sleep apnoea treatment within the last 12 months before study inclusion (positive airway pressure, mandibular advancement device, positional therapy)
- Use, or need for chronic use, of any non-invasive positive pressure ventilation device
- Participation in an interventional study and/or receiving investigational treatment(s)
- 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
- 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)
Trial locations and contacts
18 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 11 countries
Greece4 sites, 4 recruiting
- Recruiting
Department of Pulmonology, University General Hospital of Alexandroupolis, Medical School, Democritus University of Thrace
Alexandroupoli, Evros, 68100
Savvas Katsaridis, M.Sc., +306981783387, savvaskatsaridis@gmail.com
Paschalis Steiropoulos, Prof. Dr.
- Not yet recruiting
Division of Pulmonology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Medical School
Athens
Georgia Trakada, Prof. Dr., +306945205079, gtrakada@med.uoa.gr
Georgia Trakada, Prof. Dr.
- Recruiting
University of Crete
Heraklion, 71500
Izolde Bouloukaki, Dr., 00306932978636, izolthi@gmail.com
Sofia E Schiza, Prof. Dr.
- Not yet recruiting
Respiratory Failure Unit, G. Papanikolaou Hospital
Thessaloniki
George Kalamaras, MD, +306942601079, kalamaras.giorgos@gmail.com
Athanasia Pataka, Prof. Dr.
Belgium2 sites, 2 recruiting
- Not yet recruiting
Antwerp University Hospital
Antwerp, Antwerp, B-2650
Johan Verbraecken, Prof. Dr., +3238213593, johan.verbraecken@uza.be
Johan Verbraecken, Prof. Dr.
- Recruiting
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Lien Hermans, M.Sc., +3216348308, lien.hermans@uzleuven.be
Dries Testelmans, Prof. Dr.
Italy2 sites, 2 recruiting
- Not yet recruiting
Istituto Auxologico Italiano
Milan, 20149
Elisa Perger, Dr., +393487727722, e.perger@auxologico.it
Carolina Lombardi, Prof. Dr.
- Recruiting
Istituti Clinici Scientifici Maugeri IRCCS
Pavia, 27100
Francesco Fanfulla, Dr., +390382592010, francesco.fanfulla@icsmaugeri.it
Francesco Fanfulla, Dr.
Portugal2 sites, 2 recruiting
- Recruiting
Hospital Beatriz Ângelo, Unidade Local de Saúde Loures-Odivelas
Loures, 2674-514
Margarida Aguiar, Dr., +351967933656, margarida.aguiar5@gmail.com
Margarida Aguiar, Dr.
- Recruiting
Unidade Local de Saúde de Gaia e Espinho ULSGE - Unidade de Patologia do Sons
Vila Nova de Gaia, Porto District, 4434-502
Daniela Ferreira, Dr., +34919400109, danisaferreira@gmail.com
Daniela Ferreira, Dr.
Romania2 sites, 2 recruiting
- Recruiting
Clinica Somnolog
Bucharest
Oana Claudia Deleanu, Dr., +40213356910/1415, oanadeleanu@gmail.com
Oana Claudia Deleanu, Dr.
- Recruiting
University of Medicine and Pharmacy Dr. Victor Babes
Timișoara
Stefan Mihaicuta, Dr., +40744867743, stefan.mihaicuta@umft.ro
France1 site, 1 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, Isère, 38043 Cedex 9
Sébastien Baillieul, Dr., +33623574355, Sbaillieul@chu-grenoble.fr
Renaud Tamisier, Prof. Dr.
Germany1 site, 1 recruiting
- Recruiting
Wissenschaftliches Institut Bethanien für Pneumologie e.V.
Solingen, 42699
Marcel Treml, Dr., +49212636661, marcel.treml@klinik-bethanien.de
Winfried J Randerath, Prof. Dr.
Poland1 site, 1 recruiting
- Recruiting
Institute of Tuberculosis and Lung Diseases
Warsaw, Masovian Voivodeship, 01-138
Paweł Śliwiński, Prof. Dr., +48606623567, p.sliwinski@wp.pl
Paweł Śliwiński, Prof. Dr.
Slovenia1 site, 1 recruiting
- Recruiting
University Clinic of Respiratory and Allergic Diseases Golnik
Golnik, 4204
Kristina Ziherl, MD, +38631448619, kristina.ziherl@klinika-golnik.si
Kristina Ziherl, MD
Switzerland1 site, 1 recruiting
- Not yet recruiting
Klinik für Pneumologie Universitätsspital Zürich
Zurich
Esther I Schwarz, Prof. Dr., +41442552838, estherirene.schwarz@usz.ch
Esther I Schwarz, Prof. Dr.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ege University, Faculty of Medicine, Department of Respiratory Medicine
Izmir
Özen K Basoglu, Prof. Dr., +905326703464, ozen.basoglu@ege.edu.tr
Özen K Basoglu, Prof. Dr.
About this study
Official title: A Modified Baveno Classification of Obstructive Sleep Apnoea Based on Sleepiness and Cardiovascular Scores: A Prospective Observational Cohort Study
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.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| weak treatment indication | Patients with obstructive sleep apnoea (OSA) for whom OSA-specific treatment is generally not recommended according to the Baveno classification | |
| intermediate treatment indication | Patients with obstructive sleep apnoea (OSA) for whom OSA-specific treatment should be considered based on individual assessment according to the Baveno classification | |
| strong treatment indication | Patients with obstructive sleep apnoea (OSA) for whom OSA-specific treatment is generally recommended according to the Baveno classification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daytime sleepiness as measured by the Epworth Sleepiness Scale
The Epworth Sleepiness Scale total score ranges from 0-24. Higher values represent a larger extent of daytime sleepiness
Measured: From enrollment to the end of the individual observation period at 36 months
Change in office systolic blood pressure
Measured: From enrollment to the end of the individual observation period at 36 months
Secondary outcomes (9)
Change in office diastolic blood pressure
Measured: From enrollment to the end of the individual observation period at 36 months
Cardiovascular events (MACE) occurring after study inclusion, including but not limited to myocardial infarction, stroke, hospitalisation for cardiovascular-related treatment (e.g. heart failure, arrhythmia)
Measured: From enrollment to the end of the individual observation period at 36 months
Average OSA treatment usage
Average usage of the prescribed treatment for obstructive sleep apnea, measured as hours per day, derived from therapy device data
Measured: From enrollment to the end of the individual observation period at 36 months
Number of patients who discontinue OSA treatment
Measured: From enrollment to the end of the individual observation period at 36 months
Change in Insomnia Severity Index total score
The Insomnia Severity Index (ISI) total score ranges from 0-28. Higher scores represent a larger extent of insomnia-related symptoms. Scores of 15 and above are indicative of clinical insomnia.
Measured: From enrollment to the end of the individual observation period at 36 months
Change in subjective sleep length
Subjective sleep length as assessed via personal interview, measured in hours per night
Measured: From enrollment to the end of the individual observation period at 36 months
Change in Fatigue Severity Scale mean score
The Fatigue Severity Scale (FSS) mean score ranges from 0-7, with higher values indicating a larger extent of fatigue.
Measured: From enrollment to the end of the individual observation period at 36 months
Change in cognitive performance as assessed by the Montreal Cognitive Assessment (MoCA) total score
The Montreal Cognitive Assessment (MoCA) total score ranges from 0-30. A higher score represents a better cognitive performance. A result of 26 or higher is considered normal.
Measured: From enrollment to the end of the individual observation period at 36 months
Change in average oxygen desaturation area as measured by overnight oximetry
The average oxygen desaturation area (unit: s*%) is automatically calculated from the oximetry signal of a single night poly(somno)graphy. Higher values indicate a larger extent of hypoxic burden.
Measured: From enrollment to the end of the individual observation period at 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start24 Mar 2025
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.V
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Winfried J Randerath, Prof. Dr., Principal investigator, Wissenschaftliches Institut Bethanien für Pneumologie e.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861686
- Sponsor's protocol ID
- WI_24-1422
- Status last verified
- Dec 2025
- First submitted
- 24 Feb 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modified Baveno Classification of Obstructive Sleep Apnoea Based on Sleepiness and Cardiovascular Scores: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06861686
- Acronym / sponsor ID
- WI_24-1422
- Conditions
- Obstructive Sleep Apnea (OSA)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.VUniversity, hospital or other
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| weak treatment indication | – | –Patients with obstructive sleep apnoea (OSA) for whom OSA-specific treatment is generally not recommended according to the Baveno classification |
| intermediate treatment indication | – | –Patients with obstructive sleep apnoea (OSA) for whom OSA-specific treatment should be considered based on individual assessment according to the Baveno classification |
| strong treatment indication | – | –Patients with obstructive sleep apnoea (OSA) for whom OSA-specific treatment is generally recommended according to the Baveno classification |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected obstructive sleep apnoea presenting for sleep medical evaluation
Key inclusion criteria (3 listed)
- Adult patient ≥40 years at the time of signed informed consent
- 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.
- Signed and dated written informed consent in accordance with ICH-GCP and applicable local regulations
Key exclusion criteria (6 listed)
- >30% central respiratory events (apnoeas and hypopnoeas) within the diagnostic sleep study
- Established sleep apnoea treatment within the last 12 months before study inclusion (positive airway pressure, mandibular advancement device, positional therapy)
- Use, or need for chronic use, of any non-invasive positive pressure ventilation device
- Participation in an interventional study and/or receiving investigational treatment(s)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in daytime sleepiness as measured by the Epworth Sleepiness Scale
Time frame: 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
Time frame: From enrollment to the end of the individual observation period at 36 months
9 secondary outcomes
Change in office diastolic blood pressure
Time frame: From enrollment to the end of the individual observation period at 36 months
Cardiovascular events (MACE) occurring after study inclusion, including but not limited to myocardial infarction, stroke, hospitalisation for cardiovascular-related treatment (e.g. heart failure, arrhythmia)
Time frame: From enrollment to the end of the individual observation period at 36 months
Average OSA treatment usage
Time frame: From enrollment to the end of the individual observation period at 36 months
Number of patients who discontinue OSA treatment
Time frame: From enrollment to the end of the individual observation period at 36 months
Change in Insomnia Severity Index total score
Time frame: From enrollment to the end of the individual observation period at 36 months
Change in subjective sleep length
Time frame: From enrollment to the end of the individual observation period at 36 months
Change in Fatigue Severity Scale mean score
Time frame: From enrollment to the end of the individual observation period at 36 months
Change in cognitive performance as assessed by the Montreal Cognitive Assessment (MoCA) total score
Time frame: From enrollment to the end of the individual observation period at 36 months
Change in average oxygen desaturation area as measured by overnight oximetry
Time frame: From enrollment to the end of the individual observation period at 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Winfried J Randerath, Prof. Dr. principal investigator
Wissenschaftliches Institut Bethanien für Pneumologie e.V.
18 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea (OSA), run by Wissenschaftliches Institut Bethanien e.V at 18 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Greece, Belgium, Italy, Portugal, Romania and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcel Treml, Dr. (+49212636661, marcel.treml@klinik-bethanien.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daytime sleepiness as measured by the Epworth Sleepiness Scale (time frame: From enrollment to the end of the individual observation period at 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.