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NCT05929079
Apnea, Body Weight
Anniston, Alabama, United States
View Trial DetailsNCT Number: NCT07594288
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.
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Notify Me18 year–80 year
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
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
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
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
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 (%)
Time frame: Baseline sleep study assessment
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 (%)
Time frame: Baseline clinical evaluation
Measure Description: Presence of hypertension, diabetes mellitus, cardiovascular disease, or atrial fibrillation used in Baveno classification.
Measurement Tool: Clinical medical record review Unit of Measure: Number and percentage of participants
Hisar Intercontinental Hospital
Other
Retrospective Evaluation of the Baveno Classification in Comparison With Polysomnography Results in Patients With Obstructive Sleep Apnea
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