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CompletedNCT06938932Updated May 14, 2026

Effects of Environmental Heat Exposure on Human Multiple Organ Function

An interventional study of High temperature exposure and Moderate temperature exposure in Heat Stress Disorders, Wounds and Injuries and Body Temperature Changes, sponsored by Yinan Qu. Completed at 1 site in China. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by Yinan Qu · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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.

Read the detailed description

The objective of this study is to study changes in functions of multiple organs under heat exposure, which mainly include changes of cardiac function and lung function. In addition, biological samples such as blood samples, nasal fluid, and urine, etc were collected to explore changes in biomarkers such as complete blood count, liver function, kidney function, and inflammatory indicators, etc. Biochemical analysis and omics analysis were conducted to study the changes of human physiological function caused by heat exposure.

02

Conditions studied

  • Heat Stress Disorders
  • Wounds and Injuries
  • Body Temperature Changes
  • Multiple Organ Dysfunction
03

In context

Heat Stress Disorders

118 studies on the registry are indexed under Heat Stress Disorders; 45 are open to participants now.

This study's enrollment of 27 is above the median of 24 across 104 interventional studies indexed under Heat Stress Disorders.

Browse Heat Stress Disorders studies →

Lead sponsor

This is the only study on the registry with Yinan Qu as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Chinese nationality（aged 18-30 years healthy males and females）;
  2. With ability to read and understand Chinese smoothly;
  3. Living in Jinan during the study period;
  4. ≥ 18.5 and ≤ 28;
  5. Normal resting ；
  6. Normal lung function: i. Forced vital capacity (FVC)≥80% of that predicted for gender, ethnicity, age and height; ii. (FEV1) ≥80% of that predicted for gender, ethnicity, age and height; iii. FEV1/FVC ratio≥80% of predicted values.

Exclusion criteria

Exclusion Criteria:

  1. Medications or dietary supplements intake that may alter body temperature during the study period;
  2. 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;
  3. Subjects with anemia, needle fainting and other signs unsuitable for blood drawing；
  4. Subjects with cardiovascular diseases or other chronic medical condition, such as congenital heart disease, pulmonary heart disease, and hypertension, etc;
  5. Subjects with a history of major cardio-vascular, respiratory, or nervous system surgery, etc;
  6. Subjects with neurologic disorders, such as stroke, traumatic brain injury, epilepsy, and depression;
  7. Subjects with allergic diseases, such as allergic rhinitis and allergic asthma, etc;
  8. Subjects are pregnant, attempting to become pregnant or breastfeeding;
  9. 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;
  10. Subjects living with a smoker who smokes inside the house;
  11. Subjects who are current drinking or have frequent alcohol use (defined as at least 1 time per week) in the past 6 months;
  12. Provisional exclusion criteria, such as acute infection in the past two weeks or taking antibiotics. (Subjects can be enrolled after 2 weeks)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    High temperature group

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

    Other: High temperature exposure

  • Sham comparator
    Moderate temperature group

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

    Other: Moderate temperature exposure

Interventions

  • OtherHigh temperature exposure

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

  • OtherModerate temperature exposure

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

06

What researchers measure

Primary outcomes

  1. Systolic and diastolic blood pressure

    Brachial arterial blood pressure will be measured

    Time frame: 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.

  2. Cardiac output

    Cardiac output will be measured by heart color ultrasound

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

  3. Heart rate variability

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

    Time frame: 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.

  4. 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.

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

  5. Changes of forced vital capacity (FVC)

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

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

  6. Changes of peak expiratory flow rate (PEF)

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

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

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

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

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

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

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

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

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

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

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

  10. Inflammatory factors and antioxidant-related biomarkers in nasal cavity fluid

    Inflammatory factors were detected by the ELASA

    Time frame: Collect nasal fluid samples half an hour before exposure and half an hour after exposure

Secondary outcomes

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

    The differential metabolic profiling in peripheral blood related to high temperature exposure will be detected by mass spectrometry-based non-targeted metabolomics.

    Time frame: Prior to and 1 hour after exposure

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

    The differential transcriptome in peripheral blood related to high temperature exposure will be detected by mass spectrometry-based non-targeted transcriptomics.

    Time frame: Prior to and 1 hour after exposure

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

    The differentially expressed proteins in peripheral blood related to high temperature exposure will be detected by non-targeted proteomics

    Time frame: Prior to and 1 hour after exposure

  4. EEG power in α band

    EEG power in α band will be monitored by EEG measuring instrument

    Time frame: 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.

  5. EEG power in θ band

    EEG power in θ band will be monitored by EEG measuring instrument

    Time frame: 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.

  6. EEG power in β band

    EEG power in β band will be monitored by EEG measuring instrument

    Time frame: EEG power in β 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.

  7. EEG power in δ band

    EEG power in δ band will be monitored by EEG measuring instrument

    Time frame: EEG power in δ 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.

  8. Response event-related potentials (ERPs)

    ERPs will be monitored by EEG measuring instrument, including P300, N1/P1 and so on.

    Time frame: ERPs 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.

  9. Frequency domain and energy ratio index, θ/β ratio

    θ/β ratio will be monitored by EEG measuring instrument, which is an important parameter for response frequency domain and energy ratio index

    Time frame: θ/β ratio 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.

  10. Cerebral blood flow changes

    Cerebral blood flow changes will be measured by transcranial doppler

    Time frame: Cerebral blood flow changes will be examed within half an hour before exposure and half an hour after exposure.

  11. Differences in proteomics detected in nasal fluid between the two exposures and before and after each exposure

    Collect nasal fluid samples for proteomics analysis

    Time frame: Prior to and 1 hour after exposure

Other outcomes

  1. Change in tumor necrosis factor-α (TNF-α) concentrations

    TNF-α will be tested through blood samples

    Time frame: Prior to and 1 hour after exposure

  2. Change in C reactive protein (CRP) concentrations

    CRP will be tested through blood samples

    Time frame: Prior to and 1 hour after exposure

  3. Change in interleukin-6 (IL-6) concentrations

    IL-6 will be tested through blood samples

    Time frame: Prior to and 1 hour after exposure

  4. Change in interleukin-1β (IL-1β) concentrations

    IL-1β will be tested through blood samples

    Time frame: Prior to and 1 hour after exposure

  5. Change in liver function indicators

    Liver function indexes will be tested through blood samples, including glutamic-pyruvic transaminase (ALT), glutamic oxalacetic transaminase (AST), glutamyltranspeptidase (GGT), alkaline phosphatase (ALP), total protein (TP), albumin(ALB), total bilirubin (TBIL), direct bilirubin (DBIL) and so on.

    Time frame: Prior to and 1 hour after exposure

  6. Change in kidney function indicators

    Liver function indexes will be tested through blood samples, including urea nitrogen (BUN), creatinine (CR), Cystatin C (CYS C) and so on.

    Time frame: Prior to and 1 hour after exposure

  7. Change in Uric Acid (UA)

    UA will be tested through blood samples

    Time frame: Prior to and 1 hour after exposure

  8. Change in myocardial and vascular injury indicators

    myocardial and vascular injury indicators will be tested through blood samples, including creatine kinase (CK), Creatine Kinase Isoenzyme (CKMB), lactic dehydrogenase (LDH), α-hydroxybutyrate kinase and so on.

    Time frame: Prior to and 1 hour after exposure

  9. Change in coagulation indicators

    Coagulation indicators will be tested through prothrombin time(PT), activated partial thromboplastin time (APTT), plasma fibrinogen (FIB), thrombin time (TT) and so on.

    Time frame: Prior to and 1 hour after exposure

  10. Blood routine examination

    A routine test in the blood test, including red blood cells, white blood cells, platelets and other aspects of the test.

    Time frame: Prior to and 1 hour after exposure

  11. Routine urianlysis

    A routine test in the urine sample, including urine specific gravity and so on.

    Time frame: Prior to and 1 hour after exposure

  12. Change in D-lactic acid

    D-lactic acid will be tested through blood samples

    Time frame: Prior to and 1 hour after exposure

  13. Change in diamine oxidase(DAO)

    DAO will be tested through blood samples

    Time frame: Prior to and 1 hour after exposure

  14. Weight

    Weight will be measured using a scale, wearing only short-sleeved shorts and slippers

    Time frame: Prior to exposure and immediately after the exposure session

07

Study locations

1 site
  • Shandong University
    Jinan, Shandong, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2025 to primary completion in May 2025, 0 months.

Of 75 non-industry interventional studies with no phase under Heat Stress Disorders, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's 0 months is below that.

Counting every sponsor, half of 75 studies reached it within 16 months; a quarter within 4 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 4, 2025
First posted
Apr 22, 2025
StartActual
May 21, 2025
Primary completionActual
May 31, 2025
CompletionActual
Jun 30, 2025
Last update
May 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06938932
Lead sponsor
Yinan Qu
Collaborators
Qilu Hospital of Shandong University
Responsible party
Yinan Qu (Master, Shandong University) — Sponsor-investigator
First posted
Apr 22, 2025
Start date
May 21, 2025
Primary completion
May 31, 2025
Completion
Jun 30, 2025
Last update
May 14, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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