Obstructive Sleep Apnea in the Absence of Metabolic Syndrome
Obstructive Sleep Apnea in the Absence of Metabolic Syndrome: Pulse Wave Velocity, Inflammatory and Oxidative Stress Markers
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.
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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São Paulo、巴西、04020-060
- Associação Fundo de Incentivo à Pesquisa
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- male subjects
- apnea-hypopnea index > 15/h (OSA group)
- apnea-hypopnea index < 5/h (control group)
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:控制
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实验性的:Obstructive sleep apnea
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CPAP pressure is individually prescript according to polysomnography for CPAP titration
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Inflammatory marker (high sensitive C-reactive protein)
大体时间:3 months
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3 months
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Oxidative stress marker (homocysteine, cysteine and paraoxonase-1 activity)
大体时间:3 months
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3 months
|
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Arterial stiffness (pulse wave velocity)
大体时间:3 months
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3 months
|
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Angiotensin converting enzyme activity
大体时间:3 months
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3 months
|
合作者和调查者
合作者
调查人员
- 首席研究员:Daniela K. Andaku, MSc、Associação Fundo de Incentivo à Pesquisa
- 学习椅:Sônia M. Togeiro, PhD、Associação Fundo de Incentivo à Pesquisa
- 学习椅:Vânia D'Almeida, PhD、Associação Fundo de Incentivo à Pesquisa
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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