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

NCT ID: NCT07061990

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 119 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-05-01

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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Simple OSAHS Group

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

Polysomnography (PSG)

Intervention Type: 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.

Brain Magnetic Resonance Imaging (MRI)

Intervention Type: 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.

Serum Inflammatory Marker Measurement

Intervention Type: 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

Patients diagnosed with OSAHS complicated with asymptomatic lacunar infarction.

Polysomnography (PSG)

Intervention Type: 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.

Brain Magnetic Resonance Imaging (MRI)

Intervention Type: 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.

Serum Inflammatory Marker Measurement

Intervention Type: 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.

Control Group

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

Polysomnography (PSG)

Intervention Type: 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.

Brain Magnetic Resonance Imaging (MRI)

Intervention Type: 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.

Serum Inflammatory Marker Measurement

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yanpeng Li

OTHER

Sponsor Role: lead

Responsible Party

Yanpeng Li

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The First Affiliated Hospital of Hebei North University

Zhangjiakou, Hebei, China

Countries

China

Other Identifiers

2022A-34

Identifier Type: -

Identifier Source: org_study_id