Obstructive Sleep Apnea in the Absence of Metabolic Syndrome: Pulse Wave Velocity, Inflammatory and Oxidative Stress Markers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Inflammatory marker (high sensitive C-reactive protein)
研究概览
简要总结
Obstructive Sleep Apnea (OSA) is commonly associated with factors that increase cardiovascular risk, including Metabolic Syndrome (MS). There is a lack of well-controlled clinical studies investigating the independent effects of OSA in the development of cardiovascular disease, especially evaluating jointly mechanisms involved in these disorders such as inflammatory response, oxidative stress and vascular changes. The investigators hypothesized that in the absence of MetS, the mechanisms involved on cardiovascular consequences in OSA patients would be less important.
The purpose of this study is to analyze the effects of OSA in the absence of MS, on inflammatory, oxidative stress and vascular markers; to verify the influence of excessive daytime sleepiness (EDS) on the same parameters; and additionally verify the effects of nasal continuous positive airway pressure (nCPAP)in theses parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 60 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •male subjects
- •apnea-hypopnea index > 15/h (OSA group)
- •apnea-hypopnea index < 5/h (control group)
排除标准
- •body mass index (BMI) > 30 kg/m2
- •age > 60 years
- •chronic obstructive pulmonary disease
- •cardiac diseases
- •diabetes mellitus
- •metabolic syndrome according to modified National Cholesterol Education Program Adult Treatment Panel III criteria
- •previous OSA treatment
结局指标
主要结局
Inflammatory marker (high sensitive C-reactive protein)
时间窗: 3 months
Oxidative stress marker (homocysteine, cysteine and paraoxonase-1 activity)
时间窗: 3 months
Arterial stiffness (pulse wave velocity)
时间窗: 3 months
Angiotensin converting enzyme activity
时间窗: 3 months
次要结局
未报告次要终点
研究者
Daniela Kuguimoto Andaku Olenscki
Doctoral researcher
Associação Fundo de Incentivo à Pesquisa
