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NCT Number: NCT06654167

Acute Effects of Cold Exposure on Cognitive Function

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. Results of simple reaction time

    Time frame: before exposure and immediately after the exposure session

    Investigators plan to measure the changes of cognitive function using visual memory test

  2. Activated brain regions demonstrating neural activity related to the high temperature exposure

    Time frame: 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.

  3. Activated brain regions demonstrating neural connectivity related to the high temperature exposure

    Time frame: 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.

  4. Activated brain regions demonstrating neural synchronization related to the high temperature exposure

    Time frame: 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.

  5. Changes of skin temperature

    Time frame: 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

Other outcomes

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

    Time frame: 1 hour after the exposure session

    Illumina-based transcriptomics is non-targeted. The study is to find the differentially expressed exosome RNA in serum after low temperature exposure

  2. Change in brain-derived neurotrophic factor (BDNF) concentrations

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

    Change in the concentrations of BDNF in blood.

  3. Change in glial cell line-derived neurotrophic factor (GDNF) concentrations

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

    Change in the concentrations of GDNF in blood.

  4. Change in γ-aminobutyric acid (GABA) concentrations

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

    Change in the concentrations of GABA in blood.

  5. Change in Interleukin-1β (IL-1β) concentrations

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

    Change in the concentrations of IL-1β in blood.

  6. Change in Interferon-β (IFN-β) concentrations

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

    Change in the concentrations of IFN-β in blood.

  7. Change in glutathione (GSH) concentrations

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

    Change in the concentrations of GSH in blood.

  8. Changes of the scores of thermal sensation questionnaires

    Time frame: before exposure and immediately after the exposure session

    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.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Acute Effects of Cold Exposure on Cognitive Function and Underlying Mechanism

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Oct 23, 2024
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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