Cardiovascular SystemRespiratory SystemCognitive Function
Investigational drug(s) / intervention(s)
Low temperature (16#) groupModerate temperature (22#) group
Low temperature (16#) group: The exposure group will be exposed to low temperature (16#) 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 low temperature exposure and the underlying mechanisms.
Eligibility
Sex
ALL
Min age
18 Years
Max age
30 Years
Healthy volunteers
Accepted
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 the 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 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)
Heart Rate Variability Parameters — Volunteers will be asked to wear electrographic Holter monitors for 24 hours from 1:00 P.M. at the day of intervention to 1:00 P.M. at the next day. Investigators plan to measure heart rate variability (HRV) parameters (e.g., SDNN, PNN50, LF, HF)
Blood Pressure — Blood pressure will be examined before exposure and immediately after the exposure session The changes of systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be measured.
Forced vital capacity — Lung function will be examined before exposure and half an hour after the exposure session Investigators plan to measure forced vital capacity (FVC) by spirometry
Forced expiratory volume in one second — Lung function will be examined before exposure and half an hour after the exposure session Investigators plan to measure forced expiratory volume in one second (FEV1) by spirometry.
Maximal mid-expiratory flow — Lung function will be examined before exposure and half an hour after the exposure session Investigators plan to measure maximal mid-expiratory flow (MMEF) by spirometry.
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.
Trial sites (1)
Facility
City
Region
Status
Department of Environmental Health, School of Public Health, Fudan University
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.
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