Effects of Environmental Heat Exposure on Human Multiple Organ Function (NCT06938932) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effects of Environmental Heat Exposure on Human Multiple Organ Function
China24 participantsStarted 2025-04-21
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 range18 Years – 30 Years
SexALL
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;
✕. 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;
What they're measuring
1
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.
2
Cardiac output
Timeframe: Cardiac output will be checked within half an hour before exposure and immediately after exposure.
3
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.
4
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.
5
Changes of forced vital capacity (FVC)
Timeframe: FVC will be checked within half an hour before exposure and 15 minutes after exposure.
6
Changes of peak expiratory flow rate (PEF)
Timeframe: 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)