XOR Levels in OSA Patients (XOR-OSA)
NCT Number: NCT06554496
Acronym: XOR-OSA
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obstructive Sleep Apnea
Interventions: DEVICE: CPAP Treatment
Sponsor: Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-12-31
Locations: The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210029, China

Summary:
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.

Primary Outcome Measures: Xanthine Oxidoreductase (XOR) Activity, 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)., Baseline and 3 months of CPAP therapy|Apnea-Hypopnea Index (AHI), 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., Baseline and 3 months of CPAP therapy.
Secondary Outcome Measures: Uric Acid Levels, Assess changes in serum uric acid levels, reported in milligrams per deciliter (mg/dL), using ELISA., Baseline and 3 months of CPAP therapy|Endothelial Nitric Oxide Synthase (eNOS) Activity, Measure changes in eNOS activity in serum, reported in units per liter (U/L), using ELISA., Baseline and 3 months of CPAP therapy|C-Reactive Protein (CRP) Levels, Measure changes in C-reactive protein levels in serum, reported in milligrams per liter (mg/L), using ELISA., Baseline and 3 months of CPAP therapy|Superoxide Dismutase (SOD) Activity, Assess changes in superoxide dismutase activity in serum, reported in units per milliliter (U/mL), using ELISA., Baseline and 3 months of CPAP therapy.|Time with Oxygen Saturation Below 90% (T90%), 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%., Baseline and 3 months of CPAP therapy.|Subjective Sleepiness, 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., Baseline and 3 months of CPAP therapy.