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临床试验/NCT06654167
NCT06654167进行中(未招募)不适用

Acute Effects of Cold Exposure on Cognitive Function and Underlying Mechanism

Fudan University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Results of Stroop Tests

研究概览

简要总结

This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of low-temperature exposure on cognitive function and the underlying mechanisms.

详细描述

The investigators will conduct a randomized controlled human exposure crossover study among about 40 healthy young adults in Shanghai, China. Each subject will be exposed twice: once to the low temperature (15℃) and once to the moderate temperature (22℃) in a chamber for about 2 hours. During the exposure session, each subject will be requested to rest. Health examinations will be conducted immediately prior to exposure, during the period of exposure, and after exposure. Health examinations include cognitive function tests and magnetic resonance imaging. Investigators plan to collect blood and urine samples.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Living in Shanghai during the study period;
  • •Body mass index > 18.5 and ≤ 28;
  • •right-handed;
  • •receiving or having received higher education;
  • •with the ability to read and understand Chinese smoothly.

排除标准

  • •Smoking and alcohol abuse;
  • •Current drug and dietary supplements intake;
  • •Subjects with allergic diseases, such as allergic rhinitis, allergic asthma, and atopy;
  • •Subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, and hypertension;
  • •Subjects with respiratory diseases, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease;
  • •Subjects with chronic diseases, such as diabetes, chronic hepatitis, and kidney disease;
  • •Subjects who have a history of major surgery due to the cardiovascular, cerebrovascular, respiratory, or neurological diseases;
  • •Subjects with neurologic disorders, such as stroke, traumatic brain injury, epilepsy, and schizophrenia;
  • •Abnormal spirometry (FEV1 and FVC ≤ 75% of predicted and FEV1/FVC ≤ 0.65);
  • •Subjects with color vision disabilities.

研究组 & 干预措施

Low temperature (15℃) group

Experimental

Subjects in the exposure group will be exposed to low temperature (15℃) for about 2 hours in a chamber.

干预措施: Low temperature (15℃) group (Other)

Moderate temperature (22℃) group

Experimental

Subjects in the exposure group will be exposed to moderate temperature (22℃) for about 2 hours in a chamber.

干预措施: Moderate temperature (22℃) group (Other)

结局指标

主要结局

Results of Stroop Tests

时间窗: before exposure and immediately after the exposure session

Investigators plan to measure the changes of cognitive function using Stroop Test. The time taken to complete the test could reflect cognitive function, and a shorter time means better cognitive function.

次要结局

  • Results of simple reaction time(before exposure and immediately after the exposure session)
  • Activated brain regions demonstrating neural activity related to the high temperature exposure(1 hour after exposure session)
  • Activated brain regions demonstrating neural connectivity related to the high temperature exposure(1 hour after exposure session)
  • Activated brain regions demonstrating neural synchronization related to the high temperature exposure(1 hour after exposure session)
  • Changes of skin temperature(Skin temperature will be examined during the 2-hour exposure session (i.e., 1:00 P.M. to 3:00 P.M. on the day of the exposure session))

研究者

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

Renjie Chen

Professor

Fudan University

研究点 (1)

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