Baveno Classification Versus Polysomnography in Obstructive Sleep Apnea

NCT07594288 | Completed

• 1 other identifier: HHI-OSA-2026-05-001
• Study Type: observational
• Target: 395
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstructive Sleep Apnea

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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)

  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

  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

  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

  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 (%)

  Time Frame: Baseline sleep study assessment

Secondary Outcomes (1)

• Reclassification rate of PAP indication

  Baseline sleep study assessment

Other Outcomes (1)

• Presence of major cardiometabolic comorbidity

  Baseline clinical evaluation

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hisar Intercontinental Hospital: lead

Related Publications (6)

• 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.

  PMID: 41562843 RESULT

• Randerath 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.

  PMID: 33681346 RESULT

• Ehab 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.

  PMID: 38131877 RESULT

• Randerath 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.

  PMID: 34853097 RESULT

• Sousa 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.

  PMID: 35199843 RESULT

• Matthes 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.

  PMID: 39481866 RESULT

Related Links

• Official website of Hisar Intercontinental Hospital, providing general information about the institution where the study was conducted.

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Orhan Dalkılıç, MD

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

  PRINCIPAL INVESTIGATOR

• Nesrin Sarıman, MD, Prof.

  Department of Pulmonology, Hisar Intercontinental Hospital , Istanbul, Turkiye

  PRINCIPAL INVESTIGATOR

• Bekir Sami Uyanık, MD, Prof.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Clinical Biochemistry

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 18, 2026
• Study Start: January 1, 2016
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share