Acute Effects of Cold Exposure on Cognitive Function

Acute Effects of Cold Exposure on Cognitive Function and Underlying Mechanism

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cognitive Function
• Intervention / Treatment: Other: Moderate temperature (22℃) group; Other: Low temperature (15℃) group

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Department of Environmental Health, School of Public Health, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moderate temperature (22℃) group; Subjects in the exposure group will be exposed to moderate temperature (22℃) for about 2 hours in a chamber.	Other: Moderate temperature (22℃) group; The exposure group will be exposed to thermoneutral temperature (22℃) in a chamber for about 2 hours, resting during the whole period.
Experimental: Low temperature (15℃) group; Subjects in the exposure group will be exposed to low temperature (15℃) for about 2 hours in a chamber.	Other: Low temperature (15℃) group; The exposure group will be exposed to low temperature (15℃) in a chamber for about 2 hours, resting during the whole period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Results of Stroop Tests	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.	before exposure and immediately after the exposure session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activated brain regions demonstrating neural activity related to the high temperature exposure	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.	1 hour after exposure session
Activated brain regions demonstrating neural connectivity related to the high temperature exposure	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.	1 hour after exposure session
Activated brain regions demonstrating neural synchronization related to the high temperature exposure	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.	1 hour after exposure session
Results of simple reaction time	Investigators plan to measure the changes of cognitive function using visual memory test	before exposure and immediately after the exposure session
Changes of skin temperature	The changes of wrist skin temperature will be measured	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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of the scores of thermal sensation questionnaires	Changes of scores of thermal sensation questionnaires which ranged from -5 to 5. Zero score refers to the thermal comfort sensation. Higher scores refer to more uncomfortable sensations of hot. Lower scores refer to more uncomfortable sensations of cold.	before exposure and immediately after the exposure session
Change in brain-derived neurotrophic factor (BDNF) concentrations	Change in the concentrations of BDNF in blood.	1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
Change in glial cell line-derived neurotrophic factor (GDNF) concentrations	Change in the concentrations of GDNF in blood.	1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
Differences in RNA expression levels detected in serum transcriptomics between the two exposures	Illumina-based transcriptomics is non-targeted. The study is to find the differentially expressed exosome RNA in serum after low temperature exposure	1 hour after the exposure session
Change in γ-aminobutyric acid (GABA) concentrations	Change in the concentrations of GABA in blood.	1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
Change in Interleukin-1β (IL-1β) concentrations	Change in the concentrations of IL-1β in blood.	1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
Change in Interferon-β (IFN-β) concentrations	Change in the concentrations of IFN-β in blood.	1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
Change in glutathione (GSH) concentrations	Change in the concentrations of GSH in blood.	1:00 P.M. on the day of the exposure session, 1 hour after the exposure session

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Study Director: Haidong Kan, PhD, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2024
• Primary Completion (Actual): November 16, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Cognitive function; Low temperature
• Other Study ID Numbers: IRB#2024-10-1168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No