Retrospective Evaluation of the Baveno Classification in Comparison With Polysomnography Results in Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 395
- 主要终点
- Concordance between PSG-based and Baveno-based PAP treatment indication
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Concordance between PSG-based and Baveno-based PAP treatment indication
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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 (%)
次要结局
- Reclassification rate of PAP indication(Baseline sleep study assessment)
研究者
Bekir Sami Uyanık
Professor, Clinical Biochemistry
Hisar Intercontinental Hospital