Effects of Environmental Heat Exposure on Human Multiple Organ Function

NCT06938932 | Not Yet Recruiting

• 1 other identifier: LL20241102
• Study Type: interventional
• Target: 24
• 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

Heat Stress Disorders; Wounds and Injuries; Body Temperature Changes; Multiple Organ Dysfunction

Outcome Measures

Primary Outcomes (9)

• Systolic and diastolic blood pressure

  Brachial arterial blood pressure will be measured

  Systolic and diastolic blood pressure will be measured within 15 minutes before exposure and immediately after the exposure session, and every 15 minutes during exposure.

• Cardiac output

  Cardiac output will be measured by heart color ultrasound

  Cardiac output will be checked within half an hour before exposure and immediately after exposure.

• Heart rate variability

  Heart rate variability will be measured using 24-hour holter electrocardiogram

  Cardiac variability will be monitored in real time from half an hour before exposure to half an hour after exposure, with data automatically recorded every 8 seconds.

• Change of forced expired volume in the first second (FEV1)

  The changes of FEV1 will be measured by a smart spirometer. 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 will be checked within half an hour before exposure and 15 minutes after exposure.

• Changes of forced vital capacity (FVC)

  The changes of FVC will be measured by a smart spirometer.

  FVC will be checked within half an hour before exposure and 15 minutes after exposure.

• Changes of peak expiratory flow rate (PEF)

  The changes of PEF will be measured by a smart spirometer.

  PEF will be checked within half an hour before exposure and 15 minutes after exposure.

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

  The changes of MEF25 will be measured by a smart spirometer.

  MEF25 will be checked within half an hour before exposure and 15 minutes after exposure.

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

  The changes of MEF50 will be measured by a smart spirometer.

  MEF50 will be checked within half an hour before exposure and 15 minutes after exposure.

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

  The changes of MEF75 will be measured by a smart spirometer.

  MEF75 will be checked within half an hour before exposure and 15 minutes after exposure.

Secondary Outcomes (10)

• Differences in metabolic profiling detected in blood between the two exposures and before and after each exposure

  Prior to and 1 hour after exposure

• Differences in transcriptome detected in blood between the two exposures and before and after each exposure

  Prior to and 1 hour after exposure

• Differences in proteome detected in blood between the two exposures and before and after each exposure

  Prior to and 1 hour after exposure

• EEG power in α band

  EEG power in α band will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day.

• EEG power in θ band

  EEG power in θ band will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day.

Other Outcomes (14)

• Change in tumor necrosis factor-α (TNF-α) concentrations

  Prior to and 1 hour after exposure

• Change in C reactive protein (CRP) concentrations

  Prior to and 1 hour after exposure

• Change in interleukin-6 (IL-6) concentrations

  Prior to and 1 hour after exposure

Study Arms (2)

High temperature group

EXPERIMENTAL

This group including 24 healthy subjects will be exposed to high temperature for about 3 hours in a chamber.

Other: High temperature exposure

Moderate temperature group

SHAM COMPARATOR

This group including 24 healthy subjects will be exposed to moderate temperature for about 3 hours in a chamber.

Other: Moderate temperature exposure

Interventions

High temperature exposure OTHER

Subjects will be exposed to 35 degree Celsius and 45% relative humidity for 3 hours, resting during the whole periods.

High temperature group

Moderate temperature exposure OTHER

Subjects will be exposed to 24degree Celsius and 45% relative humidity for 3 hours, resting during the whole periods.

Moderate temperature group

Eligibility Criteria

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

You may qualify if:

• Chinese nationality（aged 18-30 years healthy males and females）;
• With ability to read and understand Chinese smoothly;
• Living in Jinan during the study period;
• Body mass index ≥ 18.5 and ≤ 28;
• Normal resting ECG；
• Normal lung function: i. Forced vital capacity (FVC)≥80% of that predicted for gender, ethnicity, age and height; ii. Forced expiratory volume in one second (FEV1) ≥80% of that predicted for gender, ethnicity, age and height; iii. FEV1/FVC ratio≥80% of predicted values.

You may not qualify if:

• Medications or dietary supplements intake that may alter body temperature during the study period;
• Subjects with anemia, needle fainting and other signs unsuitable for blood drawing；
• Subjects with cardiovascular diseases or other chronic medical condition, such as congenital heart disease, pulmonary heart disease, and hypertension, etc;
• Subjects with a history of major cardio-vascular, respiratory, or nervous system surgery, etc;
• Subjects with neurologic disorders, such as stroke, traumatic brain injury, epilepsy, and depression;
• Subjects with allergic diseases, such as allergic rhinitis and allergic asthma, etc;
• Subjects are pregnant, attempting to become pregnant or breastfeeding;
• Subjects who are currently smoking (including vaping, hookah and e-cigarette) or have smoking history within 1 year of study (defined as more than 1 pk/yr in the past year) or have a greater than equal to a 5 pack year smoking history;
• Subjects living with a smoker who smokes inside the house;
• Subjects who are current drinking or have frequent alcohol use (defined as at least 1 time per week) in the past 6 months;

Sponsors & Collaborators

• Yinan Qu: lead
• Qilu Hospital of Shandong University: collaborator

Study Sites (1)

Shandong University

Jinan, Shandong, China

Location

MeSH Terms

Conditions

Heat Stress Disorders; Wounds and Injuries; Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Qi Zhao PhD

CONTACT

+86 15550483437; qi.zhao@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be informed of the study interventions before providing informed consent but will be masked to the order of exposure (i.e., participants will not know the exposure conditions). Data will be blinded prior to analysis.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 22, 2025
• Study Start: April 21, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)