Acute Effects of Cold Exposure on Cardiovascular System

Официальное название

Acute Effects of Cold Exposure on Cardiovascular System and Potential Mechanism in Healthy Young Adults: A Randomized Controlled Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Blood Pressure [Срок оценки: Blood pressure will be examined before exposure and immediately after the exposure session]
• SDNN (standard deviation of NN intervals) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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.]

Вторичные конечные точки (2)

• Changes of scores of symptoms questionnaires [Срок оценки: The questionnaires will be conducted before exposure and immediately after the exposure]
• Changes of skin temperature [Срок оценки: Skin temperature will be examined during the 2-hour exposure session]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Department of Environmental Health, School of Public Health, Fudan University — Шанхай

Идентификаторы

NCT: NCT06652425 · IRB#2024-10-1167

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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