Obstructive Sleep Apnea Severity and Xanthine Oxidoreductase Activity: Mechanisms and Clinical Implications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Apnea-Hypopnea Index (AHI)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 80 years.
- •Diagnosed with Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)(apnea-hypopnea index≥5/h).
- •First-time diagnosis, with no previous surgical interventions or CPAP treatment for OSA.
- •Ability and willingness to provide informed consent for participation in the study.
排除标准
- •History of severe stroke or cerebral hemorrhage, or presence of neurological or psychiatric conditions that could affect study results.
- •Presence of active malignancies or other severe underlying diseases, such as severe liver or kidney dysfunction. Diagnosed with diabetes or other significant vascular diseases.
- •Presence of severe chronic obstructive pulmonary disease (COPD), severe asthma, severe pulmonary hypertension, or heart failure caused by any condition.
- •Pregnancy or having other conditions that make participation in this study unsuitable.
- •Extremely debilitated patients or those with severe underlying conditions.
结局指标
主要结局
Apnea-Hypopnea Index (AHI)
时间窗: 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.
Xanthine Oxidoreductase (XOR) Activity
时间窗: 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).
次要结局
- C-Reactive Protein (CRP) Levels(Baseline and 3 months of CPAP therapy)
- Time with Oxygen Saturation Below 90% (T90%)(Baseline and 3 months of CPAP therapy.)
- Superoxide Dismutase (SOD) Activity(Baseline and 3 months of CPAP therapy.)
- Subjective Sleepiness(Baseline and 3 months of CPAP therapy.)
- Uric Acid Levels(Baseline and 3 months of CPAP therapy)
- Endothelial Nitric Oxide Synthase (eNOS) Activity(Baseline and 3 months of CPAP therapy)
研究者
Ning Ding
Principal Investigator
Nanjing Medical University