Obstructive Sleep ApneaNCT07594288
Baveno Classification Versus Polysomnography in Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea, run by Hisar Intercontinental Hospital.
Trial summary
Obstructive sleep apnea is a common disorder associated with significant cardiovascular and metabolic risks. Polysomnography is considered the gold standard for diagnosis and severity assessment; however, it may not fully reflect symptom burden and comorbidity profiles. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 395 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of adult patients with obstructive sleep apnea who underwent overnight polysomnography at a tertiary care sleep laboratory between January 2016 and June 2024. Participants were identified through electronic medical records and sleep laboratory archives. Only patients with complete clinical and polysomnographic data, including symptom burden and comorbidity profiles, were included. All patients were evaluated using both polysomnography-based severity classification and the Baveno classification system for comparative analysis.
Who may be able to join
- Age ≥18 years
- Patients diagnosed with obstructive sleep apnea
- Patients who underwent full-night diagnostic polysomnography
- Availability of complete polysomnographic parameters, including apnea-hypopnea index, oxygen desaturation index, and oxygen saturation measurements
- Availability of clinical variables required for Baveno classification
- Patients evaluated between January 2016 and June 2024
- Availability of complete electronic medical records
Who cannot join
- Age <18 years
- Central sleep apnea syndrome
- Prior positive airway pressure therapy before diagnostic polysomnography
- Incomplete polysomnography data
- Missing clinical or laboratory records required for Baveno classification
- Duplicate patient records
Show all 11Show fewer
- Repeated polysomnography examinations from the same patient (only the first eligible sleep study included)
- Severe technical artifacts affecting polysomnography interpretation
- Pregnancy
- Neuromuscular disorders affecting respiratory function
- Acute respiratory infection during sleep testing
About this study
Official title: Retrospective Evaluation of the Baveno Classification in Comparison With Polysomnography Results in Patients With Obstructive Sleep Apnea
Obstructive sleep apnea is a common disorder associated with significant cardiovascular and metabolic risks. Polysomnography is considered the gold standard for diagnosis and severity assessment; however, it may not fully reflect symptom burden and comorbidity profiles. The Baveno classification has been proposed as a multidimensional clinical tool that integrates symptoms and comorbidities to guide treatment decisions.
This retrospective study aims to evaluate the agreement between the Baveno classification and polysomnography results in patients with obstructive sleep apnea. The study includes adult patients who underwent overnight polysomnography between January 2016 and June 2024. Clinical data, including symptom burden and comorbid conditions, were collected from medical records and used to classify patients according to the Baveno system.
Read more
The primary objective is to assess the concordance between the Baveno classification and polysomnography-based disease severity and treatment recommendations. Secondary analyses explore the distribution of disease severity across Baveno groups and the potential implications for clinical decision-making.
The findings of this study may provide insight into the clinical utility of the Baveno classification as a complementary tool to polysomnography in the management of obstructive sleep apnea.
Read the detailed description
Obstructive sleep apnea is a heterogeneous disorder characterized not only by the frequency of respiratory events during sleep but also by variable symptom burden and associated comorbidities. While polysomnography remains the reference standard for diagnosis and severity classification, reliance on respiratory event indices alone may not fully capture the clinical complexity of the disease. The Baveno classification has been proposed as a multidimensional approach that incorporates symptom burden and comorbidity status to support individualized management strategies.
This retrospective observational study evaluates the relationship between the Baveno classification and polysomnography-based findings in patients with obstructive sleep apnea. The study population consists of adult patients who underwent overnight polysomnography in a tertiary care sleep laboratory between January 2016 and June 2024. Demographic, clinical, and sleep study data were retrieved from institutional electronic medical records and sleep laboratory archives.
Patients were categorized according to polysomnography-based disease severity using the apnea-hypopnea index and separately classified into Baveno groups based on symptom burden and the presence of comorbid conditions. The analysis focuses on the level of agreement between these two classification approaches and their implications for treatment decision-making. In particular, concordance in treatment recommendations derived from each classification framework is examined.
By comparing a physiology-based diagnostic standard with a clinically oriented classification system, this study aims to provide further evidence regarding the applicability of multidimensional assessment strategies in the management of obstructive sleep apnea.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Polysomnography, Baveno Classification, Apnea Hypopnea Index, Continuous Positive Airway Pressure, Retrospective Study
- 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 |
|---|---|---|
| Patients with Obstructive Sleep Apnea | Adult patients diagnosed with obstructive sleep apnea who underwent overnight polysomnography between January 2016 and June 2024 were included in this retrospective observational study. Clinical, demographic, and sleep study data were obtained from electronic medical records and sleep laboratory archives. All participants were evaluated using both polysomnography-based severity classification and the Baveno classification system. The study focuses on the agreement between these classification approaches and their implications for treatment decision-making. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between PSG-based and Baveno-based PAP treatment indication
Description: Agreement between PSG-defined PAP indication (AHI ≥15 events/hour) and Baveno-based PAP indication (Groups B/C/D vs Group A).
Measurement Tool: Cohen's kappa coefficient (κ) Unit of Measure: Kappa value (κ)
Measured: Time Frame: Baseline sleep study assessment
Apnea-Hypopnea Index (AHI)
Description: OSA severity assessed by overnight polysomnography. Measurement Tool: Full-night PSG Unit of Measure: Events/hour
Measured: Time Frame: Baseline sleep study assessment
Epworth Sleepiness Scale (ESS) score
Description: Daytime sleepiness assessed using ESS questionnaire. Scale Range: 0-24; higher scores indicate greater sleepiness. Unit of Measure: ESS score
Measured: Time Frame: Baseline clinical evaluation
Oxygen Desaturation Index (ODI)
Description: Frequency of oxygen desaturation events measured during overnight polysomnography.
Measurement Tool: Full-night PSG Unit of Measure: Events/hour
Measured: Time Frame: Baseline sleep study assessment
Minimum Oxygen Saturation (Minimum SpO₂)
Description: Lowest oxygen saturation level recorded during overnight polysomnography.
Measurement Tool: Pulse oximetry during PSG Unit of Measure: Percentage (%)
Measured: Time Frame: Baseline sleep study assessment
Secondary outcomes (1)
Reclassification rate of PAP indication
Measure Description: Proportion of patients whose PAP treatment recommendation differed between PSG-based classification and Baveno classification.
Measurement Tool: Cross-classification analysis Unit of Measure: Percentage (%)
Measured: Baseline sleep study assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Jan 2016
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hisar Intercontinental Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bekir Sami Uyanık, Hisar Intercontinental Hospital
- Investigators
- Orhan Dalkılıç, MD, Principal investigator, Department of Pulmonology, Hisar Intercontinental Hospital and Uskudar University School of Medicine, Istanbul, TurkiyeNesrin Sarıman, MD, Prof., Principal investigator, Department of Pulmonology, Hisar Intercontinental Hospital , Istanbul, TurkiyeBekir Sami Uyanık, MD, Prof., Principal investigator, Department of Clinical Biochemistry, Hisar Intercontinental Hospital, Istanbul, Turkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594288
- Sponsor's protocol ID
- HHI-OSA-2026-05-001
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional policies and data protection regulations. The study is based on retrospective data collected from a single center, and although the data are anonymized, sharing is restricted to protect patient confidentiality and comply with applicable data privacy requirements.
Publications
Rosales W, Vanka SC, Singh H, Bhamrah P, Bhamrah M, Ghildiyal N, Liendo C, Asghar S, Alexander JS, Chernyshev OY. Clinical Phenotypes of Obstructive Sleep Apnea: A Decade of Evidence Toward Personalized Management. Pathophysiology. 2025 Dec 22;33(1):2. doi: 10.3390/pathophysiology33010002.
PubMed 41562843Randerath WJ, Herkenrath S, Treml M, Grote L, Hedner J, Bonsignore MR, Pepin JL, Ryan S, Schiza S, Verbraecken J, McNicholas WT, Pataka A, Sliwinski P, Basoglu OK. Evaluation of a multicomponent grading system for obstructive sleep apnoea: the Baveno classification. ERJ Open Res. 2021 Mar 1;7(1):00928-2020. doi: 10.1183/23120541.00928-2020. eCollection 2021 Jan.
PubMed 33681346Ehab A, Kempa AT, Englert H, Bittar SA, Yousef AM, Abdelwahab HW. The Baveno Classification as a Predictor of CPAP Titration Pressure in Obstructive Sleep Apnea Syndrome. Adv Respir Med. 2023 Dec 15;91(6):571-579. doi: 10.3390/arm91060042.
PubMed 38131877Randerath W, Verbraecken J, de Raaff CAL, Hedner J, Herkenrath S, Hohenhorst W, Jakob T, Marrone O, Marklund M, McNicholas WT, Morgan RL, Pepin JL, Schiza S, Skoetz N, Smyth D, Steier J, Tonia T, Trzepizur W, van Mechelen PH, Wijkstra P. European Respiratory Society guideline on non-CPAP therapies for obstructive sleep apnoea. Eur Respir Rev. 2021 Nov 30;30(162):210200. doi: 10.1183/16000617.0200-2021. Print 2021 Dec 31.
PubMed 34853097Sousa SR, Caldeira JN, Moita J. Beyond Apnea-Hypopnea Index: how clinical and comorbidity are important in obstructive sleep apnea. Adv Respir Med. 2022 Feb 14;90(2). doi: 10.5603/ARM.a2022.0028.
PubMed 35199843Matthes S, Treml M, Grote L, Hedner J, Zou D, Bonsignore MR, Pepin JL, Bailly S, Ryan S, McNicholas WT, Schiza SE, Verbraecken J, Pataka A, Sliwinski P, Basoglu OK, Lombardi C, Parati G, Randerath WJ; ESADA study group. The modified Baveno classification for obstructive sleep apnoea: development and evaluation based on the ESADA database. Eur Respir J. 2024 Dec 12;64(6):2401371. doi: 10.1183/13993003.01371-2024. Print 2024 Dec.
PubMed 39481866
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of the Baveno Classification in Comparison With Polysomnography Results in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT07594288
- Acronym / sponsor ID
- HHI-OSA-2026-05-001
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Polysomnography, Baveno Classification, Apnea Hypopnea Index, Continuous Positive Airway Pressure, Retrospective Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- Hisar Intercontinental HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 18 May 2026 (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.
Obstructive sleep apnea is a common disorder associated with significant cardiovascular and metabolic risks. Polysomnography is considered the gold standard for diagnosis and severity assessment; however, it may not fully reflect symptom burden and comorbidity profiles. The Baveno classification has been proposed as a multidimensional clinical tool that integrates symptoms and comorbidities to guide treatment decisions.
This retrospective study aims to evaluate the agreement between the Baveno classification and polysomnography results in patients with obstructive sleep apnea. The study includes adult patients who underwent overnight polysomnography between January 2016 and June 2024. Clinical data, including symptom burden and comorbid conditions, were collected from medical records and used to classify patients according to the Baveno system.
The primary objective is to assess the concordance between the Baveno classification and polysomnography-based disease severity and treatment recommendations. Secondary analyses explore the distribution of disease severity across Baveno groups and the potential implications for clinical decision-making.
The findings of this study may provide insight into the clinical utility of the Baveno classification as a complementary tool to polysomnography in the management of obstructive sleep apnea.
Detailed description
Obstructive sleep apnea is a heterogeneous disorder characterized not only by the frequency of respiratory events during sleep but also by variable symptom burden and associated comorbidities. While polysomnography remains the reference standard for diagnosis and severity classification, reliance on respiratory event indices alone may not fully capture the clinical complexity of the disease. The Baveno classification has been proposed as a multidimensional approach that incorporates symptom burden and comorbidity status to support individualized management strategies.
This retrospective observational study evaluates the relationship between the Baveno classification and polysomnography-based findings in patients with obstructive sleep apnea. The study population consists of adult patients who underwent overnight polysomnography in a tertiary care sleep laboratory between January 2016 and June 2024. Demographic, clinical, and sleep study data were retrieved from institutional electronic medical records and sleep laboratory archives.
Patients were categorized according to polysomnography-based disease severity using the apnea-hypopnea index and separately classified into Baveno groups based on symptom burden and the presence of comorbid conditions. The analysis focuses on the level of agreement between these two classification approaches and their implications for treatment decision-making. In particular, concordance in treatment recommendations derived from each classification framework is examined.
By comparing a physiology-based diagnostic standard with a clinically oriented classification system, this study aims to provide further evidence regarding the applicability of multidimensional assessment strategies in the management of obstructive sleep apnea.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Obstructive Sleep Apnea | – | –Adult patients diagnosed with obstructive sleep apnea who underwent overnight polysomnography between January 2016 and June 2024 were included in this retrospective observational study. Clinical, demographic, and sleep study data were obtained from electronic medical records and sleep laboratory archives. All participants were evaluated using both polysomnography-based severity classification and the Baveno classification system. The study focuses on the agreement between these classification approaches and their implications for treatment decision-making. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adult patients with obstructive sleep apnea who underwent overnight polysomnography at a tertiary care sleep laboratory between January 2016 and June 2024. Participants were identified through electronic medical records and sleep laboratory archives. Only patients with complete clinical and polysomnographic data, including symptom burden and comorbidity profiles, were included. All patients were evaluated using both polysomnography-based severity classification and the Baveno classification system for comparative analysis.
Key inclusion criteria (7 listed)
- Age ≥18 years
- Patients diagnosed with obstructive sleep apnea
- Patients who underwent full-night diagnostic polysomnography
- Availability of complete polysomnographic parameters, including apnea-hypopnea index, oxygen desaturation index, and oxygen saturation measurements
- Availability of clinical variables required for Baveno classification
Key exclusion criteria (11 listed)
- Age <18 years
- Central sleep apnea syndrome
- Prior positive airway pressure therapy before diagnostic polysomnography
- Incomplete polysomnography data
- Missing clinical or laboratory records required for Baveno classification
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
Concordance between PSG-based and Baveno-based PAP treatment indication
Time frame: Time Frame: Baseline sleep study assessment
Description: Agreement between PSG-defined PAP indication (AHI ≥15 events/hour) and Baveno-based PAP indication (Groups B/C/D vs Group A). Measurement Tool: Cohen's kappa coefficient (κ) Unit of Measure: Kappa value (κ)
Apnea-Hypopnea Index (AHI)
Time frame: Time Frame: Baseline sleep study assessment
Description: OSA severity assessed by overnight polysomnography. Measurement Tool: Full-night PSG Unit of Measure: Events/hour
Epworth Sleepiness Scale (ESS) score
Time frame: Time Frame: Baseline clinical evaluation
Description: Daytime sleepiness assessed using ESS questionnaire. Scale Range: 0-24; higher scores indicate greater sleepiness. Unit of Measure: ESS score
Oxygen Desaturation Index (ODI)
Time frame: Time Frame: Baseline sleep study assessment
Description: Frequency of oxygen desaturation events measured during overnight polysomnography. Measurement Tool: Full-night PSG Unit of Measure: Events/hour
Minimum Oxygen Saturation (Minimum SpO₂)
Time frame: Time Frame: Baseline sleep study assessment
Description: Lowest oxygen saturation level recorded during overnight polysomnography. Measurement Tool: Pulse oximetry during PSG Unit of Measure: Percentage (%)
1 secondary outcome
Reclassification rate of PAP indication
Time frame: Baseline sleep study assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Results publication: PubMed 41562843Rosales W, Vanka SC, Singh H, Bhamrah P, Bhamrah M, Ghildiyal N, Liendo C, Asghar S, Alexander JS, Chernyshev OY. Clinical Phenotypes of Obstructive Sleep Apnea: A Decade of Evidence Toward Personalized Management. Pathophysiology. 2025 Dec 22;33(1):2. doi: 10.3390/pathophysiology33010002.
- Results publication: PubMed 33681346Randerath WJ, Herkenrath S, Treml M, Grote L, Hedner J, Bonsignore MR, Pepin JL, Ryan S, Schiza S, Verbraecken J, McNicholas WT, Pataka A, Sliwinski P, Basoglu OK. Evaluation of a multicomponent grading system for obstructive sleep apnoea: the Baveno classification. ERJ Open Res. 2021 Mar 1;7(1):00928-2020. doi: 10.1183/23120541.00928-2020. eCollection 2021 Jan.
- Results publication: PubMed 38131877Ehab A, Kempa AT, Englert H, Bittar SA, Yousef AM, Abdelwahab HW. The Baveno Classification as a Predictor of CPAP Titration Pressure in Obstructive Sleep Apnea Syndrome. Adv Respir Med. 2023 Dec 15;91(6):571-579. doi: 10.3390/arm91060042.
- Results publication: PubMed 34853097Randerath W, Verbraecken J, de Raaff CAL, Hedner J, Herkenrath S, Hohenhorst W, Jakob T, Marrone O, Marklund M, McNicholas WT, Morgan RL, Pepin JL, Schiza S, Skoetz N, Smyth D, Steier J, Tonia T, Trzepizur W, van Mechelen PH, Wijkstra P. European Respiratory Society guideline on non-CPAP therapies for obstructive sleep apnoea. Eur Respir Rev. 2021 Nov 30;30(162):210200. doi: 10.1183/16000617.0200-2021. Print 2021 Dec 31.
- Results publication: PubMed 35199843Sousa SR, Caldeira JN, Moita J. Beyond Apnea-Hypopnea Index: how clinical and comorbidity are important in obstructive sleep apnea. Adv Respir Med. 2022 Feb 14;90(2). doi: 10.5603/ARM.a2022.0028.
- Results publication: PubMed 39481866Matthes S, Treml M, Grote L, Hedner J, Zou D, Bonsignore MR, Pepin JL, Bailly S, Ryan S, McNicholas WT, Schiza SE, Verbraecken J, Pataka A, Sliwinski P, Basoglu OK, Lombardi C, Parati G, Randerath WJ; ESADA study group. The modified Baveno classification for obstructive sleep apnoea: development and evaluation based on the ESADA database. Eur Respir J. 2024 Dec 12;64(6):2401371. doi: 10.1183/13993003.01371-2024. Print 2024 Dec.
- Official website of Hisar Intercontinental Hospital, providing general information about the institution where the study was conducted.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional policies and data protection regulations. The study is based on retrospective data collected from a single center, and although the data are anonymized, sharing is restricted to protect patient confidentiality and comply with applicable data privacy requirements.
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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. This study is not recruiting at the moment.
Orhan Dalkılıç, MD principal investigator
Department of Pulmonology, Hisar Intercontinental Hospital and Uskudar University School of Medicine, Istanbul, Turkiye
Nesrin Sarıman, MD, Prof. principal investigator
Department of Pulmonology, Hisar Intercontinental Hospital , Istanbul, Turkiye
Bekir Sami Uyanık, MD, Prof. principal investigator
Department of Clinical Biochemistry, Hisar Intercontinental Hospital, Istanbul, Turkiye
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Hisar Intercontinental Hospital.
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 7 inclusion and 11 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: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between PSG-based and Baveno-based PAP treatment indication (time frame: Time Frame: Baseline sleep study assessment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07594288, which also lists 6 linked publications.
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 18 May 2026.