Cardiovascular SystemNCT06076629
Acute Health Effects of Low Temperature Exposure
A study testing Low temperature (16#) 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 low 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?
- Low temperature (16#) group and Moderate temperature (22#) group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2023to 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 the 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;
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- 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.
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 Low 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 low temperature exposure and the underlying mechanisms.
Read the detailed description
The investigators will conduct a randomized controlled human exposure crossover study among about 50 healthy young adults in Shanghai, China. Each subject will be exposed twice: once to the low temperature (16#) and once to the moderate temperature (22#) in a chamber for about 2-2.5 hours. During the exposure session, each subject will be requested to rest. Health examinations will be conducted immediately prior to exposure (within 1 hour before the exposure session), during the period of exposure, and after exposure (within 2 hours after the exposure session). Health examinations include spirometry, Holter monitoring, blood pressure tests, cognitive function tests, symptom questionnaires, and magnetic resonance imaging. Investigators plan to collect blood, urine, exhaled breath condensate, and oropharyngeal swabs samples.
- Being tested
- Low temperature (16#) group, Moderate temperature (22#) group
- Keywords
- Low temperature, Randomized controlled trial, Cardiopulmonary effects, Cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low temperature (16#) groupOther
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#) 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 |
|---|---|---|
| Low temperature (16#) group | Experimental | Subjects in exposure group will be exposed to low temperature (16#) for about 2 hours in a chamber. Receives: Other: Low temperature (16#) 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.
Heart Rate Variability Parameters
Investigators plan to measure heart rate variability (HRV) parameters (e.g., SDNN, PNN50, LF, HF)
Measured: 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.
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
Forced vital capacity
Investigators plan to measure forced vital capacity (FVC) by spirometry
Measured: Lung function will be examined before exposure and half an hour after the exposure session
Forced expiratory volume in one second
Investigators plan to measure forced expiratory volume in one second (FEV1) by spirometry.
Measured: Lung function will be examined before exposure and half an hour after the exposure session
Maximal mid-expiratory flow
Investigators plan to measure maximal mid-expiratory flow (MMEF) by spirometry.
Measured: Lung function will be examined before exposure and half an hour after the exposure session
Results of Stroop Tests
Investigators plan to measure the changes of cognitive function using Stroop Test.
Measured: The tests will be conducted before exposure and immediately after the exposure session
Secondary outcomes (5)
Changes of skin temperature
The changes of wrist skin temperature will be measured
Measured: Skin temperature will be examined from 1:00 P.M. to 4:30 P.M. at the day of intervention
Results of simple reaction time
Investigators plan to measure the changes of cognitive function using visual simple reaction time test.
Measured: Simple reaction time will be examined before exposure and immediately after the exposure session
Results of visual memory
Investigators plan to measure the changes of cognitive function using visual memory test. Every level, a number of tiles will flash white. The participants will be required to memorize them, and pick them again after the tiles are reset. Higher levels refer to better visual memory.
Measured: Visual memory will be examined before exposure and immediately after the exposure session
Activated brain regions demonstrating brain activity related to the low temperature exposure
Investigators plan to conduct magnetic resonance imaging (MRI) after exposure. The MRI data will be processed through Data Processing and Analysis for Brain Imaging (DPABI) sofrware to obtain brain activity parameters, such as fractional amplitude of low-frequency fluctuation (fALFF). Brain regions that change after exposure between the two groups would be further idenfitied.
Measured: MRI will be examined 1 hour after the exposure session
Changes in cerebral hemodynamics demonstrating brain activity related to the low temperature exposure
Investigators plan to conduct functional near-infrared spectroscopy (fNIRS) to measure the changes in oxygenated hemoglobin and deoxygenated hemoglobin after exposure. Matlab would be applied to process data and evaluate the changes in cerebral hemodynamics associated with low temperature exposure
Measured: fNIRS will be examined before exposure and immediately after the exposure session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start10 Oct 2023
- Primary completion15 Nov 2023
- 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
- 50 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
- NCT06076629
- Sponsor's protocol ID
- FDUEH-9
- Status last verified
- Jul 2026
- First submitted
- 8 Sep 2023
- 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 Low Temperature Exposure in Healthy Young Adults: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06076629
- Acronym / sponsor ID
- FDUEH-9
- Keywords
- Low temperature, Randomized controlled trial, Cardiopulmonary effects, Cognitive function
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Oct 2023 (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 low temperature exposure and the underlying mechanisms.
Detailed description
The investigators will conduct a randomized controlled human exposure crossover study among about 50 healthy young adults in Shanghai, China. Each subject will be exposed twice: once to the low temperature (16#) and once to the moderate temperature (22#) in a chamber for about 2-2.5 hours. During the exposure session, each subject will be requested to rest. Health examinations will be conducted immediately prior to exposure (within 1 hour before the exposure session), during the period of exposure, and after exposure (within 2 hours after the exposure session). Health examinations include spirometry, Holter monitoring, blood pressure tests, cognitive function tests, symptom questionnaires, and magnetic resonance imaging. Investigators plan to collect blood, urine, exhaled breath condensate, 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 |
|---|---|---|
| Low temperature (16#) group | Experimental | Other: Low temperature (16#) groupSubjects in exposure group will be exposed to low temperature (16#) 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 the 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 |
|---|---|---|
| Low temperature (16#) groupThe exposure group will be exposed to low temperature (16#) in a chamber for about 2 hours, resting during the whole periods. | Other | Low temperature (16#) 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
Heart Rate Variability Parameters
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.
Investigators plan to measure heart rate variability (HRV) parameters (e.g., SDNN, PNN50, LF, HF)
Blood Pressure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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.
5 secondary outcomes
Changes of skin temperature
Time frame: Skin temperature will be examined from 1:00 P.M. to 4:30 P.M. at the day of intervention
Results of simple reaction time
Time frame: Simple reaction time will be examined before exposure and immediately after the exposure session
Results of visual memory
Time frame: Visual memory will be examined before exposure and immediately after the exposure session
Activated brain regions demonstrating brain activity related to the low temperature exposure
Time frame: MRI will be examined 1 hour after the exposure session
Changes in cerebral hemodynamics demonstrating brain activity related to the low temperature exposure
Time frame: fNIRS will be examined before exposure and immediately after the exposure session
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
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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 Low temperature (16#) 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?
Heart Rate Variability Parameters (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.). The study lists 6 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.