Clinical Trials in China / NCT05575752
Active, not recruiting
Not applicable
Acute Health Effects of High Temperature Exposure
NCT05575752 · tracked via the Priya Life Science China tracker
Condition(s) studied
Cardiovascular SystemRespiratory SystemCognitive Function
Investigational drug(s) / intervention(s)
high temperature (32℃) groupmoderate temperature (22℃) group
high temperature (32℃) group: The exposure group will be exposed to high temperature (32℃) in a chamber for about 2 hours, resting during the whole periods.
moderate temperature (22℃) group: The exposure group will be exposed to thermoneutral temperature (22℃) in a chamber for about 2 hours, resting during the whole periods.
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.
Eligibility
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- Changes of pulse wave velocity measured by an arteriography device performing oscillometric measurement — Pulse wave velocity will be examined before exposure and immediately after the exposure session
Pulse wave velocity (PWV) is one of the arterial stiffness indicators. The changes of PWV will be measured. - Changes of AIx@75 measured by an arteriography device performing oscillometric measurement — AIx@75 will be examined before exposure and immediately after the exposure session
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. - Changes of reflection magnitude measured by an arteriography device performing oscillometric measurement — Reflection magnitude will be examined before exposure and immediately after the exposure session
Reflection magnitude is one of the arterial stiffness indicators. The changes of reflection magnitude will be measured. - Results of Stroop Tests — The tests will be conducted before exposure and immediately after the exposure session
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. - Changes of forced expiratory volume in the first second (FEV1) — The tests will be examined before exposure and half an hour after exposure
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. - Changes of forced vital capacity (FVC) — FVC will be examined before exposure and half an hour after exposure
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. - Changes of peak expiratory flow rate (PEF) — FVC will be examined before exposure and half an hour after exposure
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. - Changes of maximum expiratory flow rate at 25% vital capacity (MEF25) — MEF25 will be examined before exposure and half an hour after exposure
Investigators plan to measure the changes of maximum expiratory flow rate at 25% vital capacity. MEF25% reflects the early stage of expiratory flow rate. - Changes of maximum expiratory flow rate at 50% vital capacity (MEF50) — MEF50 will be examined before exposure and half an hour after exposure
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. - Changes of maximum expiratory flow rate at 75% vital capacity (MEF75) — MEF75 will be examined before exposure and half an hour after exposure
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Department of Environmental Health, School of Public Health, Fudan University | Shanghai | Shanghai Municipality |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05575752 on ClinicalTrials.gov ↗ ← All trials in China