Acute Health Effects of Low Temperature Exposure

NCT06076629 | Unknown DMC

• 1 other identifier: FDUEH-9
• Study Type: interventional
• Target: 50
• 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 and the underlying mechanisms.

Conditions

Cardiovascular System; Respiratory System; Cognitive Function

Keywords

Low temperature; Randomized controlled trial; Cardiopulmonary effects; Cognitive function

Outcome Measures

Primary Outcomes (6)

• Heart Rate Variability Parameters

  Investigators plan to measure heart rate variability (HRV) parameters (e.g., SDNN, PNN50, LF, HF)

  Volunteers will be asked to wear electrographic Holter monitors for 24 hours from 1:00 P.M. at the day of intervention to 1:00 P.M. at the next day.

• Blood Pressure

  The changes of systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be measured.

  Blood pressure will be examined before exposure and immediately after the exposure session

• Forced vital capacity

  Investigators plan to measure forced vital capacity (FVC) by spirometry

  Lung function will be examined before exposure and half an hour after the exposure session

• Forced expiratory volume in one second

  Investigators plan to measure forced expiratory volume in one second (FEV1) by spirometry.

  Lung function will be examined before exposure and half an hour after the exposure session

• Maximal mid-expiratory flow

  Investigators plan to measure maximal mid-expiratory flow (MMEF) by spirometry.

  Lung function will be examined before exposure and half an hour after the exposure session

• Results of Stroop Tests

  Investigators plan to measure the changes of cognitive function using Stroop Test.

  The tests will be conducted before exposure and immediately after the exposure session

Secondary Outcomes (5)

• Changes of skin temperature

  Skin temperature will be examined from 1:00 P.M. to 4:30 P.M. at the day of intervention

• Results of simple reaction time

  Simple reaction time will be examined before exposure and immediately after the exposure session

• Results of visual memory

  Visual memory will be examined before exposure and immediately after the exposure session

• Activated brain regions demonstrating brain activity related to the low temperature exposure

  MRI will be examined 1 hour after the exposure session

• Changes in cerebral hemodynamics demonstrating brain activity related to the low temperature exposure

  fNIRS will be examined before exposure and immediately after the exposure session

Other Outcomes (7)

• Differences in metabolites detected in blood between the two exposures

  Blood will be collected 1 hour after the exposure session

• Differences in protein levels detected in blood between the two exposures

  Blood will be collected 1 hour after the exposure session

• Differences in DNA methylation levels detected in whole-blood between the two exposures

  Blood will be collected 1 hour after the exposure session

Study Arms (2)

Low temperature (16#) group

EXPERIMENTAL

Subjects in exposure group will be exposed to low temperature (16#) for about 2 hours in a chamber.

Other: Low temperature (16#) group

Moderate temperature (22#) group

SHAM COMPARATOR

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

Other: Moderate temperature (22#) group

Interventions

Low temperature (16#) group OTHER

The exposure group will be exposed to low temperature (16#) in a chamber for about 2 hours, resting during the whole periods.

Low temperature (16#) 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 periods.

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 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

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

  STUDY DIRECTOR

Central Study Contacts

Haidong Kan, PhD

CONTACT

+86-021-54237908; kanh@fudan.edu.cn

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: September 8, 2023
• First Posted: October 11, 2023
• Study Start: October 10, 2023
• Primary Completion: November 15, 2023
• Study Completion: December 31, 2024
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)