Cardiovascular Effects of Exposure to Wood Smoke in Healthy Human Adults
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in polymorphonuclear neutrophils (PMN%) in the Sputum
研究概览
简要总结
MASKOFF Clinical Trials 8/22/23
Brief Summary:
Purpose: The study is designed to investigate cardiovascular effects of young healthy human subjects exposed to wood smoke.
Participants: Approximately 80 young (18-35 years old) healthy subjects to complete.
Procedure (methods): After consenting to participate in the study, subjects will be exposed first to filtered air and on the next exposure day to approximately 500 µg/m^3 wood smoke. Both exposures will be 2 hours long with alternating 15 min of exercise (cycle ergometer) and 15 min rest period. The exercise level will be adjusted to achieve approximately 20 L/min/m^2 minute ventilation. Venous blood samples and measurements of lung, cardiac and vascular function will be made prior to and immediately following each exposure. Induced sputum samples and nasal epithelial lining fluid will be collected approximately 24 hours post each exposure.
详细描述
Wood smoke pollution is a common problem across the world, including in the US. This wood smoke comes from people using wood to heat and cook, as well as from wildfires. The purpose of this research study is to investigate the cardiovascular effects of exposure to wood smoke in young, healthy human subjects. Results from this study will also increase understanding of how wood smoke exposure adversely affects the functioning of the human cardiovascular and respiratory systems. This understanding may be especially important for patients with cardiopulmonary diseases.
There is a likelihood that due to scheduling conflicts and other unexpected scenarios (such as government shutdowns etc.) that the time between consenting and participation could be delayed, although every effort will be made to accommodate subjects without hurting the integrity of the study. There will be 5 sessions, including a consenting session which will last for about 5 hours. The two exposure-day sessions will last approximately 8-9 hours each and will occur 48 hours apart. There will also be two follow-up visits lasting approximately 4-hours each on the day following the participants' last exposure.
Before consenting to be part of this study, the potential participant must read all consent forms in entirety. The research and medical staff will then answer all of the participants' questions and explain the risks involved in this study to satisfaction.
The participant should have already undergone a general physical examination to ensure that said participant is a suitable candidate for this study. Participants who were assigned female at birth will be asked about menstrual history and a pregnancy test will be performed. This will be repeated on each exposure day if more than 7 days have lapsed since the last pregnancy test at the HSF.
Consenting Day:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in polymorphonuclear neutrophils (PMN%) in the Sputum
时间窗: Day 1, Day 3, Day 5
Airway inflammation will be assessed by the % PMN in the sputum
次要结局
- Change in Forced Expired Volume in the First Second (FEV1) (liter)(Day 1, Day 2, Day 3, Day 4, Day 5)
- Change in Forced Vital Capacity (FVC) (liter)(Day 1, Day 2, Day 3, Day 4, Day 5)
- Change in Blood Fatty Acids (ng/mL)(Day 2, Day 3, Day 4, Day 5)
- Change in Blood Cholesterol (ng/mL)(Day 2, Day 3, Day 4, Day 5)
- Change in Cytokines in Nasal Epithelial Lining Fluid (NELF) (ng/mL)(Day 1, Day 2, Day 3, Day 4, Day 5)
- Change in Diameters (mm) of Retinal Arteries and Veins(Day 2, Day 3, Day 4, Day 5)
- Percent Change in Heart Rate Variability(Day 2, Day 3, Day 4, Day 5)
- Change in interleukin-6, interleukin-8, interleukin-1 beta, and tumor-necrosis factor alpha in blood. (pg/mL)(Day 2, Day 3, Day 4, Day 5)
- Change in C-reactive protein in blood. (mg/dL)(Day 2, Day 3, Day 4, Day 5)