NCT07061990

The Role of Inflammatory Markers in OSAHS-Related White Matter Lesions and Asymptomatic Lacunar Infarction

The Role of OSAHS-related Inflammatory Markers in the Pathogenesis of White Matter Lesions and Asymptomatic Lacunar Infarction

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 119 (actual)
• Sponsor: Yanpeng Li · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This retrospective observational study aims to investigate the potential role of inflammatory markers associated with Obstructive Sleep Apnoea-Hypopnoea Syndrome (OSAHS) in the pathogenesis of white matter lesions (WML) and asymptomatic lacunar infarction (ALI). The study compares inflammatory marker levels (SAA, TNF-α, IL-6) and the severity of white matter lesions among patients with OSAHS alone, OSAHS with ALI, and a healthy control group to explore the relationship between the severity of OSAHS, inflammation, and cerebrovascular changes.

Detailed description

Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) is a prevalent condition characterized by recurrent upper airway obstruction during sleep, leading to chronic intermittent hypoxia, systemic inflammation, and endothelial dysfunction. These pathological changes are known risk factors for cerebrovascular diseases. White matter lesions and asymptomatic lacunar infarction are early indicators of cerebral small vessel disease and are associated with an increased risk of stroke and cognitive decline. While a link between OSAHS and these brain changes has been suggested, the role of specific inflammatory mediators is not fully understood. This study retrospectively analyzed data from 119 individuals who visited the sleep breathing monitoring clinic between May 2022 and May 2023. Participants were divided into three groups: a simple OSAHS group (n=60), an OSAHS group with concomitant asymptomatic lacunar infarction (combined group, n=29), and a non-OSAHS control group (n=30). The severity of OSAHS was categorized as mild, moderate, or severe based on the Apnea-Hypopnea Index (AHI). The study measured serum levels of Serum Amyloid A (SAA), Tumor Necrosis Factor-alpha (TNF-α), and Interleukin-6 (IL-6). The severity of white matter lesions was assessed using brain MRI and the Age-Related White Matter Change (ARWMC) scoring system. The primary hypothesis is that elevated levels of these OSAHS-related inflammatory markers are associated with the presence and severity of both white matter lesions and asymptomatic lacunar infarction.

Conditions

• Obstructive Sleep Apnea-hypopnea Syndrome

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Polysomnography (PSG)	Participants underwent overnight polysomnography for a minimum of 7 hours using an E series polysomnography monitor. The monitoring included electroencephalogram (EEG), eye movement, Holter monitoring, airflow, chest and abdominal respiratory movements, and fingertip oxygen saturation. The results were used to diagnose Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) and calculate the Apnea-Hypopnea Index (AHI) for severity classification.
DIAGNOSTIC_TEST	Brain Magnetic Resonance Imaging (MRI)	A whole-brain scan was performed on all participants using a Philips Ingenia 3.0T MRI scanner. The scanning sequences included T1-weighted imaging (T1WI), T2-weighted imaging (T2WI), and Fluid-Attenuated Inversion Recovery (FLAIR). The images were analyzed by two neurologists to identify asymptomatic lacunar infarction and to assess the severity of white matter lesions using the Age-Related White Matter Change (ARWMC) scoring system.
DIAGNOSTIC_TEST	Serum Inflammatory Marker Measurement	Fasting venous blood (3mL) was collected from all participants on the day of their brain MRI scan. Serum was separated by centrifugation. Levels of Serum Amyloid A (SAA), Tumor Necrosis Factor-alpha (TNF-α), and Interleukin-6 (IL-6) were measured using the Enzyme-Linked Immunosorbent Assay (ELISA) method according to the manufacturer's protocols.

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2025-07-14
• Last updated: 2025-07-14

Locations

1 site across 1 country: China