Acute Health Effects of Low Temperature Exposure in Healthy Young Adults: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Forced expiratory volume in one second
研究概览
简要总结
This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of low temperature exposure and the underlying mechanisms.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Moderate temperature (22#) group
Subjects in exposure group will be exposed to moderate temperature (22#) for about 2 hours in a chamber.
干预措施: Moderate temperature (22#) group (Other)
Low temperature (16#) group
Subjects in exposure group will be exposed to low temperature (16#) for about 2 hours in a chamber.
干预措施: Low temperature (16#) group (Other)
结局指标
主要结局
Forced expiratory volume in one second
时间窗: 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
时间窗: 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.
Heart Rate Variability Parameters
时间窗: 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
时间窗: 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
时间窗: 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
Results of Stroop Tests
时间窗: 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.
次要结局
- Results of simple reaction time(Simple reaction time will be examined before exposure and immediately after the exposure session)
- Activated brain regions demonstrating brain activity related to the low temperature exposure(MRI will be examined 1 hour after the exposure session)
- Results of visual memory(Visual memory will be examined before exposure and immediately after the exposure session)
- Changes of skin temperature(Skin temperature will be examined from 1:00 P.M. to 4:30 P.M. at the day of intervention)
- Changes in cerebral hemodynamics demonstrating brain activity related to the low temperature exposure(fNIRS will be examined before exposure and immediately after the exposure session)