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

NCT07061990 | Completed

• 1 other identifier: 2022A-34
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

OSAHS; Inflammatory Markers; White Matter Lesions; Asymptomatic Lacunar Infarction; Serum Amyloid A (SAA)

Outcome Measures

Primary Outcomes (3)

• Levels of Serum Inflammatory Markers

  Comparison of serum levels of SAA, TNF-α, and IL-6 among the simple OSAHS group, combined group, and control group.

  Measured once at the time of enrollment (on the day of brain MRI scan) during the study period from May 2022 to May 2023

• Correlation between Inflammatory Markers and OSAHS Severity

  Comparison of SAA, TNF-α, and IL-6 levels across mild, moderate, and severe OSAHS subgroups.

  Measured once at the time of enrollment during the study period from May 2022 to May 2023

• Correlation between Inflammatory Markers and White Matter Lesion Severity

  Comparison of SAA, TNF-α, and IL-6 levels among patients with normal, mild, and moderate white matter lesions based on ARWMC scores.

  Measured once at the time of enrollment during the study period from May 2022 to May 2023

Secondary Outcomes (1)

• Severity of White Matter Lesions

  Assessed once via brain MRI at the time of enrollment during the study period from May 2022 to May 2023

Study Arms (3)

Simple OSAHS Group

Patients diagnosed with OSAHS who were initially untreated and without a diagnosis of asymptomatic lacunar infarction.

Diagnostic Test: Polysomnography (PSG); Diagnostic Test: Brain Magnetic Resonance Imaging (MRI); Diagnostic Test: Serum Inflammatory Marker Measurement

Combined Group

Patients diagnosed with OSAHS complicated with asymptomatic lacunar infarction.

Diagnostic Test: Polysomnography (PSG); Diagnostic Test: Brain Magnetic Resonance Imaging (MRI); Diagnostic Test: Serum Inflammatory Marker Measurement

Control Group

Non-OSAHS individuals who underwent health examinations during the same period and did not have asymptomatic lacunar infarction.

Diagnostic Test: Polysomnography (PSG); Diagnostic Test: Brain Magnetic Resonance Imaging (MRI); Diagnostic Test: Serum Inflammatory Marker Measurement

Interventions

Polysomnography (PSG) DIAGNOSTIC_TEST

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.

Combined Group; Control Group; Simple OSAHS Group

Brain Magnetic Resonance Imaging (MRI) DIAGNOSTIC_TEST

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.

Combined Group; Control Group; Simple OSAHS Group

Serum Inflammatory Marker Measurement DIAGNOSTIC_TEST

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.

Combined Group; Control Group; Simple OSAHS Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population was sourced from individuals who visited The First Affiliated Hospital of Hebei North University between May 2022 and May 2023. Case participants (patients with OSAHS) were enrolled from the sleep breathing monitoring clinic of the Otolaryngology Department. Control participants were non-OSAHS individuals who underwent health examinations at the same hospital during the same period. All participants were over 18 years old and met detailed inclusion/exclusion criteria.

You may qualify if:

• Compliance with the diagnostic criteria for OSAHS (AHI \> 5 times/h).
• For Combined Group: Brain MRI or CT evidence of lacunar infarction (diameter ≥3 mm) without a history of acute stroke or neurological deficits.
• No prior OSAHS-related surgery or CPAP treatment.
• Availability of complete clinical data.
• Age \> 18 years old.
• Did not meet the diagnostic criteria for OSAHS (AHI \< 5 times/h).
• No evidence of asymptomatic or symptomatic cerebral infarction.
• Age \> 18 years old.

You may not qualify if:

• Symptomatic cerebral infarction, cerebral hemorrhage, brain injury, or brain tumors.
• Severe anxiety, depression, or other mental illness.
• Severe liver, kidney, heart, or lung dysfunction.
• Acute or chronic infections.
• Other severe respiratory diseases (e.g., COPD, interstitial lung disease).
• Central sleep apnea.
• Coexisting tumor or immune disorders.
• Claustrophobia.
• Pregnant women.

Sponsors & Collaborators

• Yanpeng Li: lead

Study Sites (1)

The First Affiliated Hospital of Hebei North University

Zhangjiakou, Hebei, 075000, China

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 14, 2025
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

CN (1)