Phase 4 Study of the Relationship Between the Oxidative Stress and the Development of Cardiovascular Complications in the Sleep Apnea-hypopnea Syndrome (SAHS). Effect of the Treatment With CPAP
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Plasmatic 8-isoprostane concentration
研究概览
简要总结
The purpose of this study is to compare the levels of 8-isoprostane and other oxidative stress biomarkers in plasma and condensed exhaled air between patients with SAHS and cardiovascular complications, patients with SAHS without cardiovascular complications and control subjects. To evaluate the effect of three months of treatment with CPAP on the oxidative stress biomarkers.
详细描述
Aim: To compare the levels of 8-isoprostane and other oxidative stress biomarkers in plasma and condensed exhaled air between patients with SAHS and cardiovascular complications, patients with SAHS without cardiovascular complications and control subjects. To evaluate the effect of three months of treatment with CPAP on the oxidative stress biomarkers.
Design: randomized, double blind, of parallel groups and controlled with placebo study.
Study subjects: 53 patients with SAHS (23 with cardiovascular complications and 30 without cardiovascular complications), 23 patients with cardiovascular diseases without SAHS and 23 control subjects.
Interventions: Three months of treatment with therapeutic CPAP or with sham CPAP (placebo).
Determinations: clinical (cardiovascular morbidity) and anthropometric data. Fat free corporal mass, echocardiography, spirometry, ambulatory monitoring of the arterial pressure, endothelial reactivity. Oxidative stress biomarkers (8-isoprostane, homocysteine, HIF-1, NFkB, AP-1, VEGF, ET-1, TNF-alpha, IL-1, IL-6, ICAM-1, VCAM-1, nitrates and nitrites) in plasma and condensed exhaled air.Peripheral sensitivity to hypoxia. Urinary excretion of catecholamines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sleep apnea-hypopnea syndrome (AHI > 5)
- •Excessive sleepiness (ESS > 11)
- •No previous CPAP treatment
排除标准
- •Blood pressure > 180/120 mmHg.
- •Secondary hypertension
- •Professional driver
- •COPD, asthma, bronchiectasis, lung cancer, restrictive lung disorder, chest wall disease
- •Neuromuscular disease or thyroid function abnormalities
- •Morbid obesity (BMI > 40 Kg/m2).
- •Respiratory infection in the 2 last months.
- •Anemia (Hb < 10 g/dl) or polyglobulia (Hct > 55%).
- •Diurnal hypercapnia (PaCO2 > 45 mmHg) or moderate hypoxemia (PaO2 < 70 mmHg).
结局指标
主要结局
Plasmatic 8-isoprostane concentration
时间窗: three months
次要结局
- Plasmatic and condensed exhaled air concentrations of homocysteine, HIF-1, NFkB, AP-1, VEGF, ET-1, TNF-alpha, IL-1, IL-6, ICAM-1, VCAM-1, nitrates and nitrites.(three months)