Cardiovascular SystemNCT06652425
Acute Effects of Cold Exposure on Cardiovascular System
A study testing Low temperature (15°C) group and Moderate temperature (22°C) group in people with Cardiovascular System, run by Fudan University at 1 site in China.
Trial summary
This is a randomized controlled human exposure crossover study. Investigators aim to assess the acute effects of low temperature exposure on cardiovascular system 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
- What is being tested?
- Low temperature (15°C) group and Moderate temperature (22°C) group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2024to 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Environmental Health, School of Public Health, Fudan University
Shanghai, Shanghai Municipality, 200032
Haidong Kan, PhD, +86-021-54237908, kanh@fudan.edu.cn
Renjie Chen, PhD, +86-021-54237908, chenrenjie@fudan.edu.cn
About this study
Official title: Acute Effects of Cold Exposure on Cardiovascular System and Potential Mechanism in Healthy Young Adults: A Randomized Controlled Study
This is a randomized controlled human exposure crossover study. Investigators aim to assess the acute effects of low temperature exposure on cardiovascular system and the underlying mechanisms.
Read the 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 low temperature (15°C) and once to the moderate temperature (22°C) in a chamber for about 2 hours. During the exposure session, each subject will be requested to rest. Health examinations will be conducted at baseline immediately prior to exposure, during the period of exposure, and after exposure. Health examinations include blood pressure tests and Holter monitoring. Investigators plan to collect blood and urine samples.
- Conditions
- Cardiovascular System
- Being tested
- Low temperature (15°C) group, Moderate temperature (22°C) group
- Keywords
- Low temperature, Randomized controlled trial, Cardiovascular system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low temperature (15°C) groupOther
The exposure group will be exposed to low temperature (15°C) in a chamber for about 2 hours, resting during the whole periods.
Moderate temperature (22°C) groupOther
The exposure group will be exposed to thermoneutral temperature (22°C) in a chamber for about 2 hours, resting during the whole periods.
| Study group | Role | What they receive |
|---|---|---|
| Low temperature (15°C) group | Experimental | Subjects in exposure group will be exposed to low temperature (15°C) for about 2 hours in a chamber. Receives: Other: Low temperature (15°C) group |
| Moderate temperature (22°C) group | Experimental | Subjects in exposure group will be exposed to moderate temperature (22°C) for about 2 hours in a chamber. Receives: Other: Moderate temperature (22°C) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
SDNN (standard deviation of NN intervals)
Investigators plan to measure heart rate variability (HRV) parameter SDNN
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.
SDANN (standard deviation of the averages of RR intervals)
Investigators plan to measure heart rate variability parameter SDANN
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.
rMSSD (root mean square of successive differences)
Investigators plan to measure heart rate variability (HRV) parameter rMSSD
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.
pNN50 (Percentage of differences between adjacent RR intervals greater than 50 ms)
Investigators plan to measure heart rate variability (HRV) parameter pNN50
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.
Frequency domain measures: low frequency (LF), high frequency (HF), and LF/HF ratio
Investigators plan to measure frequency domain parameters of heart rate variability (HRV)
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.
Secondary outcomes (2)
Changes of scores of symptoms questionnaires
The changes of scores of respiratory and cardiovascular symptoms questionnaires both the total and each symptom specified
Measured: The questionnaires will be conducted before exposure and immediately after the exposure
Changes of skin temperature
The changes of wrist skin temperature will be measured
Measured: Skin temperature will be examined during the 2-hour exposure session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start16 Oct 2024
- Primary completion16 Nov 2024
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renjie Chen, Fudan University
- Investigators
- Haidong Kan, PhD, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652425
- Sponsor's protocol ID
- IRB#2024-10-1167
- Status last verified
- Feb 2025
- First submitted
- 15 Oct 2024
- Last updated
- 27 Feb 2025
- 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 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Cold Exposure on Cardiovascular System and Potential Mechanism in Healthy Young Adults: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06652425
- Acronym / sponsor ID
- IRB#2024-10-1167
- Conditions
- Cardiovascular System
- Keywords
- Low temperature, Randomized controlled trial, Cardiovascular system
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 16 Nov 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Oct 2024 (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 aim to assess the acute effects of low temperature exposure on cardiovascular system 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 low temperature (15°C) and once to the moderate temperature (22°C) in a chamber for about 2 hours. During the exposure session, each subject will be requested to rest. Health examinations will be conducted at baseline immediately prior to exposure, during the period of exposure, and after exposure. Health examinations include blood pressure tests and Holter monitoring. Investigators plan to collect blood and urine 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 (15°C) group | Experimental | Other: Low temperature (15°C) groupSubjects in exposure group will be exposed to low temperature (15°C) for about 2 hours in a chamber. |
| Moderate temperature (22°C) group | Experimental | Other: Moderate temperature (22°C) groupSubjects in exposure group will be exposed to moderate temperature (22°C) 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 (15°C) groupThe exposure group will be exposed to low temperature (15°C) in a chamber for about 2 hours, resting during the whole periods. | Other | Low temperature (15°C) group |
| Moderate temperature (22°C) groupThe exposure group will be exposed to thermoneutral temperature (22°C) in a chamber for about 2 hours, resting during the whole periods. | Other | Moderate temperature (22°C) group |
Primary outcome
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.
SDNN (standard deviation of NN intervals)
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) parameter SDNN
SDANN (standard deviation of the averages of RR intervals)
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 parameter SDANN
rMSSD (root mean square of successive differences)
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) parameter rMSSD
pNN50 (Percentage of differences between adjacent RR intervals greater than 50 ms)
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) parameter pNN50
Frequency domain measures: low frequency (LF), high frequency (HF), and LF/HF ratio
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 frequency domain parameters of heart rate variability (HRV)
2 secondary outcomes
Changes of scores of symptoms questionnaires
Time frame: The questionnaires will be conducted before exposure and immediately after the exposure
Changes of skin temperature
Time frame: Skin temperature will be examined during the 2-hour 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 27 Feb 2025.
- 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.
Haidong Kan, PhD study director
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 (15°C) group and Moderate temperature (22°C) group in people with Cardiovascular 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: looking for participants now, as of the sponsor's last update on 27 Feb 2025. 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. 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?
Contact Renjie Chen, PhD (+86-021-54237908, chenrenjie@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: Blood pressure will be examined before exposure and immediately after the exposure session). 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 27 Feb 2025.