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Clinical Trials/NCT06654167
NCT06654167
Active, not recruiting
Not Applicable

Acute Effects of Cold Exposure on Cognitive Function and Underlying Mechanism

Fudan University1 site in 1 country40 target enrollmentOctober 16, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Function
Sponsor
Fudan University
Enrollment
40
Locations
1
Primary Endpoint
Results of Stroop Tests
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 16, 2024
End Date
December 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Renjie Chen

Professor

Fudan University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Results of Stroop Tests

Time Frame: 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.

Secondary Outcomes

  • 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))

Study Sites (1)

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