Clinical Trials in China / NCT06652425
Recruiting
Not applicable
Acute Effects of Cold Exposure on Cardiovascular System
NCT06652425 · tracked via the Priya Life Science China tracker
Condition(s) studied
Cardiovascular System
Investigational drug(s) / intervention(s)
Low temperature (15°C) groupModerate temperature (22°C) group
Low temperature (15°C) group: 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) group: The exposure group will be exposed to thermoneutral temperature (22°C) in a chamber for about 2 hours, resting during the whole periods.
Study 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.
Eligibility
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 the 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 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.
Primary outcome measure(s)
- 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. - SDNN (standard deviation of NN intervals) — 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) — 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) — 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) — 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 — 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)
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Department of Environmental Health, School of Public Health, Fudan University | Shanghai | Shanghai Municipality | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06652425 on ClinicalTrials.gov ↗ ← All trials in China