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临床试验/NCT01635010
NCT01635010已完成4 期

Obstructive Sleep Apnea in the Absence of Metabolic Syndrome: Pulse Wave Velocity, Inflammatory and Oxidative Stress Markers

Associação Fundo de Incentivo à Pesquisa2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2008年12月1日最近更新:
适应症

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

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

发起方
Associação Fundo de Incentivo à Pesquisa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniela Kuguimoto Andaku Olenscki

Doctoral researcher

Associação Fundo de Incentivo à Pesquisa

研究点 (2)

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