Cardiovascular SystemNCT05575752
Acute Health Effects of High Temperature Exposure
A study testing high temperature (32℃) group and moderate temperature (22℃) group in people with Cardiovascular System and Respiratory System, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular System, Respiratory System, Cognitive Function
- What is being tested?
- high temperature (32℃) group and moderate temperature (22℃) group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Environmental Health, School of Public Health, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Acute Health Effects of High Temperature Exposure in Healthy Young Adults: a Randomized Controlled Study
This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of high temperature exposure and the underlying mechanisms.
Read the detailed description
The investigators will conduct a randomized controlled human exposure crossover study among about 30 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.
- Being tested
- high temperature (32℃) group, moderate temperature (22℃) group
- Keywords
- High Temperature, Randomized controlled trial, Cardiovascular effects, cognitive function
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high temperature (32℃) groupOther
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℃) groupOther
The exposure group will be exposed to thermoneutral temperature (22℃) in a chamber for about 2 hours, resting during the whole periods.
| Study group | Role | What they receive |
|---|---|---|
| high temperature (32℃) group | Experimental | Subjects in exposure group will be exposed to high temperature (32℃) for about 2 hours in a chamber. Receives: Other: high temperature (32℃) group |
| moderate temperature (22℃) group | Sham comparator | Subjects in exposure group will be exposed to moderate temperature (22℃) for about 2 hours in a chamber. Receives: Other: moderate temperature (22℃) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of pulse wave velocity measured by an arteriography device performing oscillometric measurement
Pulse wave velocity (PWV) is one of the arterial stiffness indicators. The changes of PWV will be measured.
Measured: Pulse wave velocity will be examined before exposure and immediately after the exposure session
Changes of AIx@75 measured by an arteriography device performing oscillometric measurement
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.
Measured: AIx@75 will be examined before exposure and immediately after the exposure session
Changes of reflection magnitude measured by an arteriography device performing oscillometric measurement
Reflection magnitude is one of the arterial stiffness indicators. The changes of reflection magnitude will be measured.
Measured: Reflection magnitude will be examined before exposure and immediately after the exposure session
Results of Stroop Tests
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.
Measured: The tests will be conducted before exposure and immediately after the exposure session
Changes of forced expiratory volume in the first second (FEV1)
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.
Measured: The tests will be examined before exposure and half an hour after exposure
Changes of forced vital capacity (FVC)
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.
Measured: FVC will be examined before exposure and half an hour after exposure
Changes of peak expiratory flow rate (PEF)
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.
Measured: FVC will be examined before exposure and half an hour after exposure
Changes of maximum expiratory flow rate at 25% vital capacity (MEF25)
Investigators plan to measure the changes of maximum expiratory flow rate at 25% vital capacity. MEF25% reflects the early stage of expiratory flow rate.
Measured: MEF25 will be examined before exposure and half an hour after exposure
Changes of maximum expiratory flow rate at 50% vital capacity (MEF50)
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.
Measured: MEF50 will be examined before exposure and half an hour after exposure
Changes of maximum expiratory flow rate at 75% vital capacity (MEF75)
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.
Measured: MEF75 will be examined before exposure and half an hour after exposure
Secondary outcomes (7)
Blood Pressure
The changes of systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be measured.
Measured: Blood pressure will be examined before exposure and immediately after the exposure session
Results of Schulte table Tests
Investigators plan to measure the changes of cognitive function using Schulte table. The time taken to complete the test and the accuracy could reflect cognitive function. Less time and greater accuracy mean better cognitive function.
Measured: The tests will be conducted before exposure and immediately after the exposure session
Activated brain regions demonstrating neural 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. The fractional amplitude of low frequency fluctuation (fALFF) would be extracted to reflect neural activity of brain regions.
Measured: 1 hour after exposure session
Activated brain regions demonstrating neural connectivity 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. The degree of centrality (DC) would be extracted to reflect neural connectivity of brain regions.
Measured: 1 hour after exposure session
Activated brain regions demonstrating neural synchronization 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. The regional homogeneity (ReHo) would be extracted to reflect neural synchronization of brain regions.
Measured: 1 hour after exposure session
Changes of airway inflammation indicator fractional concentration of carbon monoxide (FeCO)
Investigators plan to measure the changes of fractional concentration of carbon monoxide.
Measured: FeCO will be examined before exposure and half an hour after exposure
Changes of airway inflammation indicator fractional exhaled nitric oxide (FeNO)
Investigators plan to measure the changes of fractional exhaled nitric oxide.
Measured: FeNO will be examined before exposure and half an hour after exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start23 Oct 2022
- Primary completion19 Nov 2022
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular SystemStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haidong Kan, Fudan University
- Investigators
- Haidong Kan, PhD, Study director, Department of Environmental Health, School of Public Health, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575752
- Sponsor's protocol ID
- FDUEH-8
- Status last verified
- Feb 2026
- First submitted
- 28 Sep 2022
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Health Effects of High Temperature Exposure in Healthy Young Adults: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05575752
- Acronym / sponsor ID
- FDUEH-8
- Keywords
- High Temperature, Randomized controlled trial, Cardiovascular effects, cognitive function
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 23 Oct 2022 (actual)
- Primary completion
- 19 Nov 2022 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 30 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high temperature (32℃) group | Experimental | Other: high temperature (32℃) groupSubjects in exposure group will be exposed to high temperature (32℃) for about 2 hours in a chamber. |
| moderate temperature (22℃) group | Sham comparator | Other: moderate temperature (22℃) groupSubjects in exposure group will be exposed to moderate temperature (22℃) for about 2 hours in a chamber. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high temperature (32℃) groupThe exposure group will be exposed to high temperature (32℃) in a chamber for about 2 hours, resting during the whole periods. | Other | high temperature (32℃) group |
| moderate temperature (22℃) groupThe exposure group will be exposed to thermoneutral temperature (22℃) in a chamber for about 2 hours, resting during the whole periods. | Other | moderate temperature (22℃) group |
Primary outcome
Changes of pulse wave velocity measured by an arteriography device performing oscillometric measurement
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
7 secondary outcomes
Blood Pressure
Time frame: Blood pressure will be examined before exposure and immediately after the exposure session
Results of Schulte table Tests
Time frame: The tests will be conducted before exposure and immediately after the exposure session
Activated brain regions demonstrating neural activity related to the high temperature exposure
Time frame: 1 hour after exposure session
Activated brain regions demonstrating neural connectivity related to the high temperature exposure
Time frame: 1 hour after exposure session
Activated brain regions demonstrating neural synchronization related to the high temperature exposure
Time frame: 1 hour after exposure session
Changes of airway inflammation indicator fractional concentration of carbon monoxide (FeCO)
Time frame: FeCO will be examined before exposure and half an hour after exposure
Changes of airway inflammation indicator fractional exhaled nitric oxide (FeNO)
Time frame: FeNO will be examined before exposure and half an hour after exposure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular System
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haidong Kan, PhD study director
Department of Environmental Health, School of Public Health, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high temperature (32℃) group and moderate temperature (22℃) group in people with Cardiovascular System and Respiratory System, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of pulse wave velocity measured by an arteriography device performing oscillometric measurement (time frame: Pulse wave velocity will be examined before exposure and immediately after the exposure session). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.