Acute Effects of Cold Exposure on Cognitive Function

Not Applicable

Active, not recruiting

• Conditions: Cognitive Function

• Registration Number: NCT06654167
• Lead Sponsor: Fudan University

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.

Study Timeline

• Study First Submitted: 2024-10-15
• Study Start: 2024-10-16
• Study First Submitted QC: 2024-10-21
• Study First Posted: 2024-10-23
• Primary Completion: 2024-11-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Results of Stroop Tests	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 Outcome Measures

Name	Time	Method
Results of simple reaction time	before exposure and immediately after the exposure session	Investigators plan to measure the changes of cognitive function using visual memory test
Activated brain regions demonstrating neural activity related to the high temperature exposure	1 hour after exposure session	Investigators plan to measure brain activity associated with high temperature exposure by magnetic resonance imaging (MRI). Brain imaging data will be extracted from MRI data. The fractional amplitude of low frequency fluctuation (fALFF) would be extracted to reflect neural activity of brain regions.
Activated brain regions demonstrating neural connectivity related to the high temperature exposure	1 hour after exposure session	Investigators plan to measure brain activity associated with high temperature exposure by magnetic resonance imaging (MRI). Brain imaging data will be extracted from MRI data. The degree of centrality (DC) would be extracted to reflect neural connectivity of brain regions.
Activated brain regions demonstrating neural synchronization related to the high temperature exposure	1 hour after exposure session	Investigators plan to measure brain activity associated with high temperature exposure by magnetic resonance imaging (MRI). Brain imaging data will be extracted from MRI data. The regional homogeneity (ReHo) would be extracted to reflect neural synchronization of brain regions.
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)	The changes of wrist skin temperature will be measured

Trial Locations

Locations (1)

Department of Environmental Health, School of Public Health, Fudan University; 🇨🇳 Shanghai, Shanghai, China