Back to resultsAcute Health Effects of High Temperature Exposure
Primary Purpose
Cardiovascular System, Respiratory System, Cognitive Function
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
high temperature (32℃) group
moderate temperature (22℃) group
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular System focused on measuring High Temperature, Randomized controlled trial, Cardiovascular effects, cognitive function
Eligibility Criteria
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.
Sites / Locations
- Department of Environmental Health, School of Public Health, Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
high temperature (32℃) group
moderate temperature (22℃) group
Arm Description
Subjects in exposure group will be exposed to high temperature (32℃) for about 2 hours in a chamber.
Subjects in exposure group will be exposed to moderate temperature (22℃) for about 2 hours in a chamber.
Outcomes
Primary Outcome Measures
Heart Rate Variability Parameters SDNN
Investigators plan to measure standard deviation of NN intervals (SDNN) in millisecond.
Results of Stroop Tests
Investigators plan to measure the changes of cognitive function using Stroop Test.
Results of schulte table Tests
Investigators plan to measure the changes of cognitive function using schulte table.
Activated brain regions demonstrating brain activity related to the high temperature exposure
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)
Investigators plan to measure the changes of forced vital capacity.
Changes of lung function indicators forced expiratory volume in 1 second (FEV1)
Investigators plan to measure the changes of forced expiratory volume in 1 second.
Changes of the scores of cardiovascular symptoms questionnaires
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
The changes of systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be measured.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05575752
Brief Title
Acute Health Effects of High Temperature Exposure
Official Title
Acute Health Effects of High Temperature Exposure in Healthy Young Adults: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 23, 2022 (Actual)
Primary Completion Date
November 19, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular System, Respiratory System, Cognitive Function
Keywords
High Temperature, Randomized controlled trial, Cardiovascular effects, cognitive function
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
high temperature (32℃) group
Arm Type
Experimental
Arm Description
Subjects in exposure group will be exposed to high temperature (32℃) for about 2 hours in a chamber.
Arm Title
moderate temperature (22℃) group
Arm Type
Sham Comparator
Arm Description
Subjects in exposure group will be exposed to moderate temperature (22℃) for about 2 hours in a chamber.
Intervention Type
Other
Intervention Name(s)
high temperature (32℃) group
Intervention Description
The exposure group will be exposed to high temperature (32℃) in a chamber for about 2 hours, resting during the whole periods.
Intervention Type
Other
Intervention Name(s)
moderate temperature (22℃) group
Intervention Description
The exposure group will be exposed to thermoneutral temperature (22℃) in a chamber for about 2 hours, resting during the whole periods.
Primary Outcome Measure Information:
Title
Heart Rate Variability Parameters SDNN
Description
Investigators plan to measure standard deviation of NN intervals (SDNN) in millisecond.
Time Frame
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.
Title
Results of Stroop Tests
Description
Investigators plan to measure the changes of cognitive function using Stroop Test.
Time Frame
The tests will be conducted before exposure and immediately after the exposure session
Title
Results of schulte table Tests
Description
Investigators plan to measure the changes of cognitive function using schulte table.
Time Frame
The tests will be conducted before exposure and immediately after the exposure session
Title
Activated brain regions demonstrating brain activity related to the high temperature exposure
Description
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.
Time Frame
1 hour after exposure session
Secondary Outcome Measure Information:
Title
Changes of lung function indicators forced vital capacity (FVC)
Description
Investigators plan to measure the changes of forced vital capacity.
Time Frame
FVC will be examined before exposure and half an hour after exposure
Title
Changes of lung function indicators forced expiratory volume in 1 second (FEV1)
Description
Investigators plan to measure the changes of forced expiratory volume in 1 second.
Time Frame
FEV1 will be examined before exposure and half an hour after exposure
Title
Changes of the scores of cardiovascular symptoms questionnaires
Description
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.
Time Frame
The cardiovascular symptoms questionnaires will be conducted before exposure and immediately after the exposure session
Title
Blood Pressure
Description
The changes of systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be measured.
Time Frame
Blood pressure will be examined before exposure and immediately after the exposure session
Other Pre-specified Outcome Measures:
Title
Differences in metabolic profiling detected in blood between the two exposures
Description
The differential metabolic profiling in blood related to high temperature exposure will be detected by mass spectrometry-based non-targeted metabolomics.
Time Frame
1 hour after the exposure session
Title
Differences in protein levels detected in blood between the two exposures
Description
The differentially expressed proteins in blood related to high temperature exposure will be detected by non-targeted proteomics.
Time Frame
1 hour after the exposure session
Title
Change in C reactive protein (CRP) concentrations
Description
Change in the concentrations of C reactive protein in blood.
Time Frame
1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
Title
Change in heat shock proteins concentrations
Description
Change in the concentrations of heat shock proteins in blood.
Time Frame
1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
Title
Changes of the scores of thermal sensation questionnaires
Description
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.
Time Frame
1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
Title
Changes of skin sebum secretion rate
Description
Evaluation of the differential sebum secretion rate between the two groups
Time Frame
half an hour after the exposure session
Title
Changes of facial secreted sebum composition
Description
Evaluation of the differential facial secreted sebum composition between the two groups
Time Frame
half an hour after the exposure session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haidong Kan, PhD
Organizational Affiliation
Department of Environmental Health, School of Public Health, Fudan University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Environmental Health, School of Public Health, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Acute Health Effects of High Temperature Exposure
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