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NCT Number: NCT07594288

Baveno Classification Versus Polysomnography in 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.

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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 (%)

Secondary outcomes

  1. Reclassification rate of PAP indication

    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 (%)

Other outcomes

  1. Presence of major cardiometabolic comorbidity

    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

Sponsors and collaborators

Lead sponsor

Hisar Intercontinental Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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