Obstructive Sleep Apnea-hypopnea SyndromeNCT07061990
The Role of Inflammatory Markers in OSAHS-Related White Matter Lesions and Asymptomatic Lacunar Infarction
An observational study of Obstructive Sleep Apnea-hypopnea Syndrome, run by Yanpeng Li at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea-hypopnea Syndrome
- What is being tested?
- Polysomnography (PSG), Brain Magnetic Resonance Imaging (MRI) and Serum Inflammatory Marker Measurement
- How many people
- 119 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 May 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- Coexisting tumor or immune disorders.
- Claustrophobia.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei, 075000
About this study
Official title: The Role of OSAHS-related Inflammatory Markers in the Pathogenesis of White Matter Lesions and Asymptomatic Lacunar Infarction
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.
Read the 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.
- Being tested
- Polysomnography (PSG), Brain Magnetic Resonance Imaging (MRI), Serum Inflammatory Marker Measurement
- Keywords
- OSAHS, Inflammatory Markers, White Matter Lesions, Asymptomatic Lacunar Infarction, Serum Amyloid A (SAA)
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Serum Inflammatory Marker MeasurementDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Simple OSAHS Group | Patients diagnosed with OSAHS who were initially untreated and without a diagnosis of asymptomatic lacunar infarction. Receives: 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. Receives: 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. Receives: Diagnostic Test: Polysomnography (PSG); Diagnostic Test: Brain Magnetic Resonance Imaging (MRI); Diagnostic Test: Serum Inflammatory Marker Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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
Comparison of the distribution of white matter lesion severity (normal, mild, moderate) among the simple OSAHS group, combined group, and control group.
Measured: Assessed once via brain MRI at the time of enrollment during the study period from May 2022 to May 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 May 2022
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea-hypopnea SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 119 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Yanpeng Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanpeng Li, The First Affiliated Hospital of Hebei North University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061990
- Sponsor's protocol ID
- 2022A-34
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of OSAHS-related Inflammatory Markers in the Pathogenesis of White Matter Lesions and Asymptomatic Lacunar Infarction
- ClinicalTrials.gov ID
- NCT07061990
- Acronym / sponsor ID
- 2022A-34
- Keywords
- OSAHS, Inflammatory Markers, White Matter Lesions, Asymptomatic Lacunar Infarction, Serum Amyloid A (SAA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Yanpeng LiUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Simple OSAHS Group | – | Diagnostic Test: Polysomnography (PSG), Diagnostic Test: Brain Magnetic Resonance Imaging (MRI), Diagnostic Test: Serum Inflammatory Marker MeasurementPatients diagnosed with OSAHS who were initially untreated and without a diagnosis of asymptomatic lacunar infarction. |
| Combined Group | – | Diagnostic Test: Polysomnography (PSG), Diagnostic Test: Brain Magnetic Resonance Imaging (MRI), Diagnostic Test: Serum Inflammatory Marker MeasurementPatients diagnosed with OSAHS complicated with asymptomatic lacunar infarction. |
| Control Group | – | Diagnostic Test: Polysomnography (PSG), Diagnostic Test: Brain Magnetic Resonance Imaging (MRI), Diagnostic Test: Serum Inflammatory Marker MeasurementNon-OSAHS individuals who underwent health examinations during the same period and did not have asymptomatic lacunar infarction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Combined Group, Control Group, Simple OSAHS Group |
| 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 | Combined Group, Control Group, Simple OSAHS Group |
| Serum Inflammatory Marker MeasurementFasting 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. | Diagnostic test | Combined Group, Control Group, Simple OSAHS Group |
Primary outcome
Levels of Serum Inflammatory Markers
Time frame: Measured once at the time of enrollment (on the day of brain MRI scan) during the study period from May 2022 to May 2023
Comparison of serum levels of SAA, TNF-α, and IL-6 among the simple OSAHS group, combined group, and control group.
Correlation between Inflammatory Markers and OSAHS Severity
Time frame: Measured once at the time of enrollment during the study period from May 2022 to May 2023
Comparison of SAA, TNF-α, and IL-6 levels across mild, moderate, and severe OSAHS subgroups.
Correlation between Inflammatory Markers and White Matter Lesion Severity
Time frame: Measured once at the time of enrollment during the study period from May 2022 to May 2023
Comparison of SAA, TNF-α, and IL-6 levels among patients with normal, mild, and moderate white matter lesions based on ARWMC scores.
1 secondary outcome
Severity of White Matter Lesions
Time frame: Assessed once via brain MRI at the time of enrollment during the study period from May 2022 to May 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea-hypopnea Syndrome, run by Yanpeng Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of Serum Inflammatory Markers (time frame: Measured once at the time of enrollment (on the day of brain MRI scan) during the study period from May 2022 to May 2023). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.