Acute Health Effects of High Temperature Exposure
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The investigators will conduct a randomized controlled human exposure crossover study among about 40 healthy young adults in Shanghai, China. Each subject will be exposed twice: once to the high temperature (32℃) and once to moderate temperature (22℃) in a chamber for about 2 hours. During the exposure session, each subject will be requested to rest. Health examinations will be conducted immediately prior to exposure, during the period of exposure and after exposure. Health examinations include symptom questionnaire, blood pressure tests, cognitive function tests, magnetic resonance imaging, skin tests, spirometry, and Holter monitoring. Investigators plan to collect blood, urine and oropharyngeal swabs samples.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: high temperature (32℃) group Subjects in exposure group will be exposed to high temperature (32℃) for about 2 hours in a chamber. |
Other: 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.
|
| Sham Comparator: moderate temperature (22℃) group Subjects in exposure group will be exposed to moderate temperature (22℃) for about 2 hours in a chamber. |
Other: 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.
|
Outcome Measures
Primary Outcome Measures
- Heart Rate Variability Parameters SDNN [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 standard deviation of NN intervals (SDNN) in millisecond.
- 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.
- Results of schulte table Tests [The tests will be conducted before exposure and immediately after the exposure session]
Investigators plan to measure the changes of cognitive function using schulte table.
- Activated brain regions demonstrating brain activity related to the high temperature exposure [1 hour after exposure session]
Investigators plan to measure brain activity associated with high temperature exposure by magnetic resonance imaging (MRI). Brain imaging data will be extracted from MRI data.
Secondary Outcome Measures
- Changes of lung function indicators 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.
- Changes of lung function indicators forced expiratory volume in 1 second (FEV1) [FEV1 will be examined before exposure and half an hour after exposure]
Investigators plan to measure the changes of forced expiratory volume in 1 second.
- Changes of the scores of cardiovascular symptoms questionnaires [The cardiovascular symptoms questionnaires will be conducted before exposure and immediately after the exposure session]
Changes of scores of cardiovascular symptoms questionnaires which ranged from 0 to 40. Higher scores of the cardiovascular symptoms questionnaires mean more severe cardiovascular symptoms.
- 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.
Other Outcome Measures
- Differences in metabolic profiling detected in blood between the two exposures [1 hour after the exposure session]
The differential metabolic profiling in blood related to high temperature exposure will be detected by mass spectrometry-based non-targeted metabolomics.
- Differences in protein levels detected in blood between the two exposures [1 hour after the exposure session]
The differentially expressed proteins in blood related to high temperature exposure will be detected by non-targeted proteomics.
- Change in C reactive protein (CRP) concentrations [1:00 P.M. on the day of the exposure session, 1 hour after the exposure session]
Change in the concentrations of C reactive protein in blood.
- Change in heat shock proteins concentrations [1:00 P.M. on the day of the exposure session, 1 hour after the exposure session]
Change in the concentrations of heat shock proteins in blood.
- Changes of the scores of thermal sensation questionnaires [1:00 P.M. on the day of the exposure session, 1 hour after the exposure session]
Changes of scores of thermal sensation questionnaires which ranged from -5 to 5. Zero score refers to the thermal comfort sensation. Higher scores refer to more uncomfortable sensations of hot. Lower scores refer to more uncomfortable sensations of cold.
- Changes of skin sebum secretion rate [half an hour after the exposure session]
Evaluation of the differential sebum secretion rate between the two groups
- Changes of facial secreted sebum composition [half an hour after the exposure session]
Evaluation of the differential facial secreted sebum composition between the two groups
Eligibility Criteria
Criteria
Inclusion Criteria:
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Living in Shanghai during the study period;
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Body mass index > 18.5 and ≤ 28;
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right-handed;
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receiving or having received higher education;
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with ability to read and understand Chinese smoothly.
Exclusion Criteria:
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Smoking and alcohol abuse;
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Current drug and dietary supplements intake;
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Subjects with allergic diseases, such as allergic rhinitis, allergic asthma, and atopy;
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Subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, and hypertension;
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Subjects with respiratory diseases, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease;
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Subjects with chronic diseases, such as diabetes, chronic hepatitis, and kidney disease;
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Subjects who have a history of major surgery due to the cardiovascular, cerebrovascular, respiratory, or neurological diseases;
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Subjects with neurologic disorders, such as stroke, traumatic brain injury, epilepsy, and schizophrenia;
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Abnormal spirometry (FEV1 and FVC ≤ 75% of predicted and FEV1/FVC ≤ 0.65);
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Subjects with color vision disabilities.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Environmental Health, School of Public Health, Fudan University | Shanghai | Shanghai | China | 200032 |
Sponsors and Collaborators
- Fudan University
Investigators
- Study Director: Haidong Kan, PhD, Department of Environmental Health, School of Public Health, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FDUEH-8