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Baveno Classification Versus Polysomnography in Obstructive Sleep Apnea

Retrospective Evaluation of the Baveno Classification in Comparison With Polysomnography Results in Patients With Obstructive Sleep Apnea

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07594288
Enrollment
395
Registered
2026-05-18
Start date
2016-01-01
Completion date
2024-06-30
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea, Polysomnography, Baveno Classification, Apnea Hypopnea Index, Continuous Positive Airway Pressure, Retrospective Study

Brief 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. 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.

Interventions

None listed

Sponsors

Hisar Intercontinental Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Minimum Oxygen Saturation (Minimum SpO₂)Time Frame: Baseline sleep study assessmentDescription: Lowest oxygen saturation level recorded during overnight polysomnography. Measurement Tool: Pulse oximetry during PSG Unit of Measure: Percentage (%)
Concordance between PSG-based and Baveno-based PAP treatment indicationTime Frame: Baseline sleep study assessmentDescription: 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: Baseline sleep study assessmentDescription: OSA severity assessed by overnight polysomnography. Measurement Tool: Full-night PSG Unit of Measure: Events/hour
Epworth Sleepiness Scale (ESS) scoreTime Frame: Baseline clinical evaluationDescription: 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: Baseline sleep study assessmentDescription: Frequency of oxygen desaturation events measured during overnight polysomnography. Measurement Tool: Full-night PSG Unit of Measure: Events/hour

Secondary

MeasureTime frameDescription
Reclassification rate of PAP indicationBaseline sleep study assessmentMeasure 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 (%)

Contacts

PRINCIPAL_INVESTIGATOROrhan Dalkılıç, MD

Department of Pulmonology, Hisar Intercontinental Hospital and Uskudar University School of Medicine, Istanbul, Turkiye

PRINCIPAL_INVESTIGATORNesrin Sarıman, MD, Prof.

Department of Pulmonology, Hisar Intercontinental Hospital , Istanbul, Turkiye

PRINCIPAL_INVESTIGATORBekir Sami Uyanık, MD, Prof.

Department of Clinical Biochemistry, Hisar Intercontinental Hospital, Istanbul, Turkiye

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026