The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, China
Location status: Recruiting
NCT Number: NCT06554496
The level of xanthine oxidoreductase (XOR) in plasma is associated with oxidative stress and inflammation. Obstructive Sleep Apnea (OSA) is characterized by repeated upper airway obstruction and apneas during sleep, leading to chronic intermittent hypoxemia. The specific role of XOR in OSA, its relationship with the severity of OSA, and the changes in XOR levels before and after CPAP treatment remain unclear. The study will enroll 80 patients from the First Affiliated Hospital of Nanjing Medical University, categorized by their Apnea-Hypopnea Index (AHI) into mild, moderate, and severe OSA groups. Participants will undergo baseline assessments including polysomnography (PSG) and measurements of XOR activity and biomarkers such as uric acid, endothelin-1 (ET-1), endothelial nitric oxide synthase (eNOS), and inflammatory markers. Eligible patients will receive CPAP treatment for 3 months, after which their XOR activity and biomarker levels will be re-evaluated to assess treatment efficacy.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Nanjing, Jiangsu, 210029, China
Location status: Recruiting
Xanthine oxidoreductase (XOR) is an enzyme involved in the oxidative metabolism of purines, producing reactive oxygen species (ROS) as byproducts. Elevated XOR activity is associated with increased oxidative stress and inflammation. In patients with Obstructive Sleep Apnea(OSA), repeated episodes of hypoxia and reoxygenation lead to oxidative stress and inflammatory responses. However, the specific changes in XOR activity in OSA patients are not well understood.
This study aims to evaluate the effects of Continuous Positive Airway Pressure (CPAP) treatment on patients with OSA by analyzing XOR activity and related biomarkers. The primary objective is to assess the correlation between XOR activity levels and the severity of OSA, and to determine how these levels change following a 3-month CPAP intervention.
The study will enroll 80 patients aged 18-80 years from the First Affiliated Hospital of Nanjing Medical University. Participants will be diagnosed with OSA according to established guidelines, and must be first-time visitors with no prior OSA surgery or CPAP treatment history. Patients with severe cerebrovascular diseases, psychiatric conditions, diagnosed diabetes with significant vascular complications, severe COPD, pulmonary hypertension, heart failure, or pregnancy will be excluded.
All participants will undergo polysomnography (PSG) to determine the Apnea-Hypopnea Index (AHI) and categorize them into mild, moderate, or severe OSA groups.
Blood samples will be collected to measure baseline XOR activity and related biomarkers, including uric acid, endothelin-1 (ET-1), endothelial nitric oxide synthase (eNOS), C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), malondialdehyde (MDA), superoxide dismutase (SOD), hypoxia-inducible factor-1 (HIF-1), and angiotensin II (Ang II).
Eligible patients will receive CPAP therapy for a duration of 3 months. Patients unsuitable for CPAP therapy will receive alternative treatments such as upper airway surgery, oral appliances, or weight reduction programs. After 3 months of CPAP therapy, participants will undergo follow-up PSG to reassess sleep parameters. Blood samples will be collected again to measure changes in XOR activity and related biomarkers.
The data collected will be analyzed using SPSS software. Correlation analysis will be performed to assess the relationship between AHI, lowest SpO2, oxygen load, blood pressure load, ESS sleepiness scores, and XOR levels. Paired t-tests will be used to compare pre- and post-treatment XOR activity and biomarker levels. Repeated measures ANOVA will be conducted to evaluate the long-term changes and sustained effects of CPAP therapy.
This study aims to provide a comprehensive understanding of the biochemical impacts of CPAP therapy on patients with OSAHS. The findings are expected to identify potential biomarkers for assessing treatment efficacy and to guide future therapeutic strategies, ultimately improving patient outcomes in clinical practice.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Continuous Positive Airway Pressure (CPAP) therapy will be administered to patients for 3 months. The CPAP device will be set to deliver a continuous flow of air at a prescribed pressure to keep the patient's airway open during sleep.
Time frame: Baseline and 3 months of CPAP therapy
To measure changes in XOR activity levels in OSA patients with different severities, using enzyme-linked immunosorbent assay (ELISA) techniques, before and after 3 months of CPAP therapy, reported in units per liter (U/L).
Time frame: Baseline and 3 months of CPAP therapy.
To measure changes in the Apnea-Hypopnea Index, quantifying the severity of sleep apnea, reported as the number of apneas and hypopneas per hour of sleep.
Time frame: Baseline and 3 months of CPAP therapy
Assess changes in serum uric acid levels, reported in milligrams per deciliter (mg/dL), using ELISA.
Time frame: Baseline and 3 months of CPAP therapy
Measure changes in eNOS activity in serum, reported in units per liter (U/L), using ELISA.
Time frame: Baseline and 3 months of CPAP therapy
Measure changes in C-reactive protein levels in serum, reported in milligrams per liter (mg/L), using ELISA.
Time frame: Baseline and 3 months of CPAP therapy.
Assess changes in superoxide dismutase activity in serum, reported in units per milliliter (U/mL), using ELISA.
Time frame: Baseline and 3 months of CPAP therapy.
To measure the duration of time spent with oxygen saturation levels below 90% during sleep, reported as a percentage of total sleep time with SpO2 below 90%.
Time frame: Baseline and 3 months of CPAP therapy.
To assess changes in subjective sleepiness using the Epworth Sleepiness Scale (ESS), which is a self-administered questionnaire. The ESS measures the general level of daytime sleepiness, or average sleep propensity in daily activities, on a scale ranging from 0 to 24. A higher score on this scale indicates a greater likelihood of falling asleep in a variety of situations, suggesting worse daytime sleepiness.
Nanjing Medical University
Other
Obstructive Sleep Apnea Severity and Xanthine Oxidoreductase Activity: Mechanisms and Clinical Implications
Acronym: XOR-OSA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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