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临床试验/NCT07237958
NCT07237958已完成不适用

Effects on the Olfactory Epithelium in the Nose and the Olfactory Nerve (Nervus Olfactorius) From Exposure to Diesel Exhaust

Umeå University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年2月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Diesel exhaust causes cellular dysfunction of the olfactory system

研究概览

简要总结

The goal of this study is to study the effect exposure to air pollution and its effect on development of dementia.

Does the diesel exhaust change the function of the olfactory system?

Have the exposures measurable effects on the sense of smell and cognitive ability?

Forty people are exposed to diesel exhaust exhaust and filtered air. The exposures are blinded and in a randomized order. Both groups undergo biopsies of the olfactory epithelium in the nose under local anesthesia after the exposures and after performing cognitive test.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • non-smoker

排除标准

  • Allergic rhinitis
  • Diabetes mellitus
  • Kidney or liver failure
  • Angina pectoris or previous ventricular arrhythmia
  • Systolic blood pressure >190 mmHg or <100 mmHg
  • Previous blood disease
  • Blood donation in the last three months prior to study start
  • Previous or ongoing tobacco smoking and exposure to air pollution in the workplace
  • Absence of informed consent

结局指标

主要结局

Diesel exhaust causes cellular dysfunction of the olfactory system

时间窗: 3 years.

RNA sequencing and DNA methylation will be conducted to identify biomarkers for acute exposure to diesel exhaust.

次要结局

  • Cognitive test(3 years)

研究者

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

Ala Muala

MD, PhD

Umeå University

研究点 (2)

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