Exhaled Markers of Oxidative Stress and Endothelium-dependent Vascular Relaxation in Obstructive Sleep Apnea. Effect of Continuous Positive Airway Pressure Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- To examine the effect of CPAP treatment on biochemical (markers of oxidative stress) abnormalities
研究概览
简要总结
Patients with sleep apnea syndrome have repeated apneic events that induce periodic hypoxia-reoxygenation, drawing away an overproduction of oxidants. This exaggerated generation of oxidants is associated with a dysfunction of the vascular endothelium that evolves, in its turn, towards cardiovascular diseases such as systemic hypertension, stroke, and myocardial infarction. The major aim of our study is to examine the effect of CPAP treatment on biochemical (markers of oxidative stress) and functional (endothelium-dependent vascular relaxation reactivity) abnormalities at 1 and 4 weeks of treatment.
详细描述
Subjects will undergo overnight polysomnography in the sleep laboratory (PSG1, D0), which will be immediately preceded and followed by measurements of oxidative stress in exhaled gas and vascular relaxation. Patients included in the OSAS group will be randomly assigned to treatment by either CPAP or Placebo (sham CPAP) for 4 weeks. Measurements of oxidative stress in exhaled gas and vascular reactivity will be repeated immediately before and after PSG2 and PSG3 at D7 and D30, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No smoking
- •30-70 years old subjects
- •being referred for daytime hyper- somnolence and snoring
- •apnea hypopnea index >=30/hour and desaturation index>=30/hour
排除标准
- •Chronic lung diseases.
- •Exposure to occupational contaminants.
- •Active smoking within last 2 years.
- •Alcoholism.
- •Chronic systemic disease other than OSAS.
- •Treatment with vasoactive drugs or antioxidants
- •Respiratory infection or vaccination during the 6 weeks preceding the PSG1.
结局指标
主要结局
To examine the effect of CPAP treatment on biochemical (markers of oxidative stress) abnormalities
时间窗: 1 and 4 weeks of treatment
次要结局
- To compare between patients with severe OSAS and controls, the degree of the production of markers of oxidative stress non-invasively measured in both the exhaled gas and urine samples(before and after a nocturnal polysomnography)
- To compare between patients and controls, the endothelium-dependent vascular relaxation(before and after nocturnal polysomnography)
- To analyze the relationship between these biochemical and functional abnormalities and the standard criteria of severity of OSAS.(before and after nocturnal polysomnography)
- To examine the effect of CPAP treatment on functional (endothelium-dependent vascular relaxation reactivity) abnormalities(1 and 4 weeks of treatment)