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

NCT07061990 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 119

Last updated 2025-07-14

No results posted yet for this study

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.

Conditions

  • Obstructive Sleep Apnea-hypopnea Syndrome

Interventions

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.

Sponsors & Collaborators

  • Yanpeng Li

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2023-05-01
Completion
2023-05-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07061990 on ClinicalTrials.gov