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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low temperature (15℃) group | Experimental | Subjects in the exposure group will be exposed to low temperature (15℃) for about 2 hours in a chamber. |
|
| Moderate temperature (22℃) group | Experimental | Subjects in the exposure group will be exposed to moderate temperature (22℃) for about 2 hours in a chamber. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low temperature (15°C) group | Other | The exposure group will be exposed to low temperature (15°C) in a chamber for about 2 hours, resting during the whole periods. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of forced expiratory volume in the first second (FEV1) | 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. | 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) |
| Changes of forced vital capacity (FVC) | 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. | 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) |
| Changes of peak expiratory flow rate (PEF) | 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. | 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) |
| Changes of maximum expiratory flow rate at 25% vital capacity (MEF25) | Investigators plan to measure the changes of maximum expiratory flow rate at 25% vital capacity. MEF25% reflects the early stage of expiratory flow rate. | 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) |
| Changes of maximum expiratory flow rate at 50% vital capacity (MEF50) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of fractional exhaled nitric oxide (FeNO) | Investigators plan to measure the changes of fractional exhaled nitric oxide using FeNO monitor (NIOX; Aerocrine AB, Solna, Sweden). FeNO reflects airway inflammation level | FeNO will be examined half an hour before exposure and half an hour after exposure |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in protein levels detected in blood Clara cell protein (CC16) between the two exposures | Investigators plan to measure the changes of Clara cell protein using enzyme linked immunosorbent assay (ELISA). Clara cell protein (CC16) indicate lung epithelial injury. | CC16 will be examined at 1:00 P.M. and 4:00 P.M. (one hour after the exposure) on the day of the exposure session |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haidong Kan, PhD | Fudan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Environmental Health, School of Public Health, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 14, 2024 | Oct 18, 2024 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D003080 | Cold Temperature |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D013696 | Temperature |
| D013816 | Thermodynamics |
| D055585 | Physical Phenomena |
| D014887 | Weather |
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| Moderate temperature (22°C) group | Other | The exposure group will be exposed to thermoneutral temperature (22°C) in a chamber for about 2 hours, resting during the whole periods. |
|
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.
| 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) |
| Changes of maximum expiratory flow rate at 75% vital capacity (MEF75) | 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. | MEF75 will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after exposure) |
| Changes of fractional concentration of carbon monoxide (FeCO) |
Investigators plan to measure the changes of fractional concentration of carbon monoxide using Pico Smokerlyzer. FeCO reflects level of carboxyhemoglobin in blood. |
| 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 | The changes of wrist skin temperature will be measured | Wrist skin temperature will be measured at 1:00 P.M. to 3:00 P.M. on the day of the exposure session |
| Differences in protein levels detected in blood chitinase-3-like protein 1 (YKL-40) between the two exposures | Investigators plan to measure the changes of chitinase-3-like protein 1 protein using enzyme linked immunosorbent assay (ELISA). YKL-40 represents airway inflammation and remodeling. | YKL-40 will be examined at 1:00 P.M. and 4:00 P.M. (one hour after exposure) on the day of the exposure session |
| Differences in protein levels detected in blood Surfactant Protein-D (SP-D) between the two exposures | Investigators plan to measure the changes of Surfactant Protein-D protein using enzyme linked immunosorbent assay (ELISA). SP-D represents pulmonary injury. | SP-D will be examined at 1:00 P.M. and 4:00 P.M. (one hour after exposure) on the day of the exposure session |
| Differences in respiratory microbiota detected in pharyngeal secretion between the two exposures | differential respiratory microbiota in pharyngeal secretion related to low temperature exposure will be detected by integrating microbial 16S rRNA sequencing and non-targeted metabolomics. | Respiratory microbiota will be detected at 3:30 A.M. (half an hour after exposure) on the day of the exposure session |
| Differences in metabolic profiling detected in exhaled breath condensate between the two exposures | The differential metabolic profiling in exhaled breath condensate related to low temperature exposure will be detected by mass spectrometry-based non-targeted metabolomics. | Metabolic profiling in exhaled breath condensate will be detected at 4:00 P.M. (1 hour after the exposure session) |
| D001272 |
| Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |
| D003710 | Demography |
| D011154 | Population Characteristics |