CompletedNot Applicable

Effects of Environmental Heat Exposure on Human Multiple Organ Function

China27 participantsStarted 2025-05-21

Plain-language 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.

Who can participate

Age range

18 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. Medications or dietary supplements intake that may alter body temperature during the study period;
. Individuals who have unspecified illnesses, which in the judgment of the investigators might increase the risk associated with heat exposure will be a basis for exclusion;
. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Systolic and diastolic blood pressure

Timeframe: 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

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

Heart rate variability

Timeframe: 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)

Timeframe: FEV1 will be checked within half an hour before exposure and 15 minutes after exposure.

Changes of forced vital capacity (FVC)

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

Changes of peak expiratory flow rate (PEF)

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

Trial details

NCT IDNCT06938932

SponsorYinan Qu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-31

View on ClinicalTrials.gov More Heat Stress Disorders trials