Acute Effects of Low Temperature Exposure on Respiratory Health 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
- 40
- 试验地点
- 1
- 主要终点
- Changes of forced expiratory volume in the first second (FEV1)
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 on respiratory health and the underlying mechanisms.
详细描述
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℃) and once to the moderate temperature (22℃) in a chamber for about 2 hours. During the exposure session, each subject will be requested to rest. Health examinations will be conducted immediately prior to exposure, during the period of exposure, and after exposure. Health examinations include lung function tests and exhaled breath test. Investigators plan to collect blood, pharyngeal secretion, exhaled breath condensate and urine 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 the 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
Low temperature (15℃) group
Subjects in the exposure group will be exposed to low temperature (15℃) for about 2 hours in a chamber.
干预措施: Low temperature (15°C) group (Other)
Moderate temperature (22℃) group
Subjects in the exposure group will be exposed to moderate temperature (22℃) for about 2 hours in a chamber.
干预措施: Moderate temperature (22°C) group (Other)
结局指标
主要结局
Changes of forced expiratory volume in the first second (FEV1)
时间窗: The tests will be conducted at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
Investigators plan to measure the changes of the forced expiratory volume in 1 s (FEV1) using a smart spirometer (Model A1, BreathHome, China) supervised by professional medical staff. Before the pulmonary function test, subjects will practice several times by themselves. During the examination, each subject stands and clamps the nose clip, and repeats the test, with the best result as the criterion. FEV1 reflect pulmonary function.
Changes of forced vital capacity (FVC)
时间窗: FVC will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
Investigators plan to measure the changes of forced vital capacity (FVC) using a portable spirometer (Jaeger Master screen V5.01; CareFusion). FVC reflects the expiratory resistance of large airways.
Changes of peak expiratory flow rate (PEF)
时间窗: FVC will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
Investigators plan to measure the changes of peak expiratory flow (PEF) using a portable spirometer (Jaeger Master screen V5.01; CareFusion). PEF reflects airway patency and respiratory muscle strength.
Changes of maximum expiratory flow rate at 25% vital capacity (MEF25)
时间窗: MEF25 will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
Investigators plan to measure the changes of maximum expiratory flow rate at 25% vital capacity. MEF25% reflects the early stage of expiratory flow rate.
Changes of maximum expiratory flow rate at 50% vital capacity (MEF50)
时间窗: MEF50 will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
Investigators plan to measure the changes of maximum expiratory flow rate at 50% vital capacity using a portable spirometer (Jaeger Master screen V5.01; CareFusion). MEF50 reflects the interim stage of expiratory flow rate.
Changes of maximum expiratory flow rate at 75% vital capacity (MEF75)
时间窗: MEF75 will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after exposure)
Investigators plan to measure the changes of maximum expiratory flow rate at 50% vital capacity (MEF75%) using a portable spirometer (Jaeger Master screen V5.01; CareFusion). MEF75 reflects the terminal stage of expiratory flow rate.
次要结局
- Changes of fractional exhaled nitric oxide (FeNO)(FeNO will be examined half an hour before exposure and half an hour after exposure)
- Changes of fractional concentration of carbon monoxide (FeCO)(FeCO will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure))
- Changes of skin temperature(Wrist skin temperature will be measured at 1:00 P.M. to 3:00 P.M. on the day of the exposure session)