Acute Health Effects of High Temperature Exposure

NCT05575752 | Active Not Recruiting DMC

• 1 other identifier: FDUEH-8
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of high temperature exposure and the underlying mechanisms.

Conditions

Cardiovascular System; Respiratory System; Cognitive Function

Keywords

High Temperature; Randomized controlled trial; Cardiovascular effects; cognitive function

Outcome Measures

Primary Outcomes (10)

• Changes of pulse wave velocity measured by an arteriography device performing oscillometric measurement

  Pulse wave velocity (PWV) is one of the arterial stiffness indicators. The changes of PWV will be measured.

  Pulse wave velocity will be examined before exposure and immediately after the exposure session

• Changes of AIx@75 measured by an arteriography device performing oscillometric measurement

  Augmentation index normalized to 75 bpm heart rate (AIx@75) is one of the arterial stiffness indicators. The changes of AIx@75 will be measured.

  AIx@75 will be examined before exposure and immediately after the exposure session

• Changes of reflection magnitude measured by an arteriography device performing oscillometric measurement

  Reflection magnitude is one of the arterial stiffness indicators. The changes of reflection magnitude will be measured.

  Reflection magnitude will be examined before exposure and immediately after the exposure session

• 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.

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

• Changes of forced expiratory volume in the first second (FEV1)

  Investigators plan to measure the changes of the forced expiratory volume in 1 s (FEV1) using a smart spirometer (Model A1, BreathHome, China) supervised by professional medical staff. Before the pulmonary function test, subjects will practice several times by themselves. During the examination, each subject stands and clamps the nose clip, and repeats the test, with the best result as the criterion. FEV1 reflect pulmonary function.

  The tests will be examined before exposure and half an hour after exposure

• Changes of forced vital capacity (FVC)

  Investigators plan to measure the changes of forced vital capacity (FVC) using spirometer (Model A1, BreathHome, China). FVC reflects the expiratory resistance of large airways.

  FVC will be examined before exposure and half an hour after exposure

• Changes of peak expiratory flow rate (PEF)

  Investigators plan to measure the changes of peak expiratory flow (PEF) using smart spirometer (Model A1, BreathHome, China). PEF reflects airway patency and respiratory muscle strength.

  FVC will be examined before exposure and half an hour after exposure

• Changes of maximum expiratory flow rate at 25% vital capacity (MEF25)

  Investigators plan to measure the changes of maximum expiratory flow rate at 25% vital capacity. MEF25% reflects the early stage of expiratory flow rate.

  MEF25 will be examined before exposure and half an hour after exposure

• Changes of maximum expiratory flow rate at 50% vital capacity (MEF50)

  Investigators plan to measure the changes of maximum expiratory flow rate at 50% vital capacity using smart spirometer (Model A1, BreathHome, China). MEF50 reflects the interim stage of expiratory flow rate.

  MEF50 will be examined before exposure and half an hour after exposure

• Changes of maximum expiratory flow rate at 75% vital capacity (MEF75)

  Investigators plan to measure the changes of maximum expiratory flow rate at 50% vital capacity (MEF75%) using smart spirometer (Model A1, BreathHome, China). MEF75 reflects the terminal stage of expiratory flow rate.

  MEF75 will be examined before exposure and half an hour after exposure

Secondary Outcomes (7)

• Blood Pressure

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

• Results of Schulte table Tests

  The tests will be conducted 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

Other Outcomes (43)

• Changes of the scores of thermal sensation questionnaires

  before exposure and immediately after the exposure session

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

  1 hour after the exposure session

• Differences in protein levels detected in blood Clara cell protein (CC16) between the two exposures

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

Study Arms (2)

high temperature (32℃) group

EXPERIMENTAL

Subjects in exposure group will be exposed to high temperature (32℃) for about 2 hours in a chamber.

Other: high temperature (32℃) 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

high temperature (32℃) group OTHER

The exposure group will be exposed to high temperature (32℃) in a chamber for about 2 hours, resting during the whole periods.

high temperature (32℃) 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 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

Conditions

Fever

Interventions

Diathermy; Population Groups

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics; Demography; Population Characteristics

Study Officials

• Haidong Kan, PhD

  Department of Environmental Health, School of Public Health, 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: September 28, 2022
• First Posted: October 12, 2022
• Study Start: October 23, 2022
• Primary Completion: November 19, 2022
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)