Acute Effects of Cold Exposure on Cardiovascular System

Not Applicable

Recruiting

• Conditions: Cardiovascular System

• Registration Number: NCT06652425
• Lead Sponsor: Fudan University

Brief 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.

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 (16°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 Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-15
• Study Start: 2024-10-16
• Study First Submitted QC: 2024-10-18
• Last Update Submitted: 2024-10-18
• Study First Posted: 2024-10-22
• Last Update Posted: 2024-10-22
• Primary Completion: 2024-11-16
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Changes of scores of symptoms questionnaires	The questionnaires will be conducted before exposure and immediately after the exposure	The changes of scores of respiratory and cardiovascular symptoms questionnaires both the total and each symptom specified
Changes of skin temperature	Skin temperature will be examined during the 2-hour exposure session	The changes of wrist skin temperature will be measured

Trial Locations

Locations (1)

Department of Environmental Health, School of Public Health, Fudan University; 🇨🇳 Shanghai, Shanghai, China