Acute Effects of Cold Exposure on Cognitive Function

NCT06654167 | Active Not Recruiting DMC

• 1 other identifier: IRB#2024-10-1168
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Function

Keywords

Low temperature; Randomized controlled trial; Cognitive function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

Other Outcomes (8)

• Differences in RNA expression levels detected in serum transcriptomics between the two exposures

  1 hour after the exposure session

• Change in brain-derived neurotrophic factor (BDNF) concentrations

  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

  1:00 P.M. on the day of the exposure session, 1 hour after the exposure session

Study Arms (2)

Low temperature (15℃) group

EXPERIMENTAL

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

Other: Low temperature (15℃) group

Moderate temperature (22℃) group

EXPERIMENTAL

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

Other: Moderate temperature (22℃) group

Interventions

Low temperature (15℃) group OTHER

The exposure group will be exposed to low temperature (15℃) in a chamber for about 2 hours, resting during the whole period.

Low temperature (15℃) group

Moderate temperature (22℃) group OTHER

The exposure group will be exposed to thermoneutral temperature (22℃) in a chamber for about 2 hours, resting during the whole period.

Moderate temperature (22℃) group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Department of Environmental Health, School of Public Health, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

Cold Temperature; Population Groups

Intervention Hierarchy (Ancestors)

Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; Demography; Population Characteristics

Study Officials

• Haidong Kan, PhD

  Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 23, 2024
• Study Start: October 16, 2024
• Primary Completion: November 16, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)