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临床试验/NCT02729129
NCT02729129已完成不适用

Face Masks to Reduce the Adverse Effects of Diesel Exhaust Inhalation

Umeå University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Vascular vasomotor function

研究概览

简要总结

Air pollution exposure is a major environmental and public health concern. The findings from controlled exposure studies have given biological plausibility to the epidemiological associations, and have defined important pathways that may be amenable to intervention. Ultimately, there is a need to address how one may protect the public from these detrimental effects. Two studies have been performed assessing the cardiovascular effects of wearing a face mask in a highly polluted urban area in China in healthy volunteers and patients with coronary heart disease. These demonstrated lower blood pressure and increased heart rate variability when wearing a face mask as compared to not. The investigators aim to test if wearing a highly efficient face mask during exposure to dilute diesel exhaust abrogates the well-known adverse cardiovascular effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy males
  • Non-smoking
  • All subjects undergo a general health examination and are required to have normal clinical examination, ECG, blood tests and lung function

排除标准

  • Metabolic or cardiovascular disease
  • Asthma or other respiratory disease
  • Respiratory infection within 2 weeks of the study
  • Antioxidant- and/or vitamin supplementation within 1 week prior to, as well as during the course of the study. (incl vitamin C, Acetylcysteine)
  • Smokers or regular snus usage

结局指标

主要结局

Vascular vasomotor function

时间窗: 2 hours

Forearm venous occlusion plethysmography to measure forearm blood flow during unilateral intrabrachial infusion of endothelial-dependent and -independent vasodilators. Assessment is shown in ml/100ml tissue/min.

次要结局

  • Fibrinolytic function(2 hours)
  • Blood pressure(24 hours)
  • Heart rate variability(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jenny Bosson

PhD, MD

Umeå University

研究点 (2)

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