A Controlled Human Environmental Study Evaluating the Impacts of Cognitive Functions During the Exposure of Simulated Wildfire-Related Air Pollution (WRAP).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Changes in plasma P-tau 217 concentration from pre-exposure to post-exposure
研究概览
简要总结
This study will examine how breathing wildfire-related air pollution (WRAP) for one hour affects healthy adults. The main question the study will answer if the effect of WRAP exposure on p-tau, a blood marker of cognitive decline. The changes in p-tau concentrations after exposure to WRAP will be compared to the changes in p-tau after exposure to clean air.
Participants will:
- Have 2 study visits - one visit with exposure to clean air and one visit with exposure to simulated wildfire smoke
- Have blood drawn before and after each exposure
- Complete cognitive tests and memory tasks before and after each exposure
详细描述
- Exposures will take place in a booth-like exposure chamber (1 x 0.7 x 1.8 m) with glass upper panels. One person will be exposed at a time.
- Simulated wildfire smoke will be generated by burning pine wood at a temperature that mimics smoldering combustion. The levels of smoke introduced into the exposure chamber are similar to those found during outdoor bonfires and wildfire events. The levels of particulate matter (PM) will be closely monitored during the exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
outside laboratories processing blood samples
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non smoker
- •Weight at least 110 pounds
- •Between ages 18 and 40 years old
排除标准
- •Claustrophobia or not comfortable in enclosed spaces.
- •Colorblindness.
- •Inability to hear verbal instructions.
- •Cardiovascular disease which, in the opinion of the investigator, would elevate the participant's risk of adverse effects to WRAP exposure. This includes a history of stroke.
- •Diabetes requiring the use of insulin.
- •Pregnancy (A pregnancy test will be provided to you).
- •Current asthma (an asthma attack within the past five years).
- •History of childhood asthma.
- •Medications which may affect cognition such as beta-blockers and CNS depressants.
- •Respiratory symptoms in the previous 4 weeks (cough, wheezing, shortness of breath, etc.) which, in the opinion of the investigator, would elevate the participant's risk of adverse effects to WRAP exposure.
- •Use of sedating cold/allergy medications in the previous week.
- •Use of marijuana in the previous week.
- •Consumption of alcohol in the previous 24 hours.
- •Kidney or liver disease.
- •Thyroid disease.
- •High blood pressure.
- •Parkinson's disease.
- •Pacemaker.
- •Hay fever.
研究组 & 干预措施
Exposure to simulated wildfire smoke, then exposure to clean air
At the first study visit the subject undergoes a 1-hour chamber exposure to simulated wildfire smoke (300 ug/m3 Particulate Matter). After a 1-week washout period, the subject undergoes a 1-hour chamber exposure to clean air (0 ug/m3 PM).
干预措施: Simulated wildfire smoke exposure (Other)
Exposure to simulated wildfire smoke, then exposure to clean air
At the first study visit the subject undergoes a 1-hour chamber exposure to simulated wildfire smoke (300 ug/m3 Particulate Matter). After a 1-week washout period, the subject undergoes a 1-hour chamber exposure to clean air (0 ug/m3 PM).
干预措施: Clean Air exposure (Other)
Exposure to clean air, then exposure to simulated wildfire smoke
At the first study visit the subject undergoes a 1-hour chamber exposure to clean air (0 ug/m3 PM). After a 1-week washout period, the subject undergoes a 1-hour chamber exposure to simulated wildfire smoke (300 ug/m3 PM).
干预措施: Simulated wildfire smoke exposure (Other)
Exposure to clean air, then exposure to simulated wildfire smoke
At the first study visit the subject undergoes a 1-hour chamber exposure to clean air (0 ug/m3 PM). After a 1-week washout period, the subject undergoes a 1-hour chamber exposure to simulated wildfire smoke (300 ug/m3 PM).
干预措施: Clean Air exposure (Other)
结局指标
主要结局
Changes in plasma P-tau 217 concentration from pre-exposure to post-exposure
时间窗: Immediately before, immediately after each exposure
Using blood samples collected pre- and post-exposure, the primary outcome will be assessed by measurement of plasma phosphorylated tau at threonine 217 (p-tau217) using an ultrasensitive immunoassay
次要结局
未报告次要终点
研究者
Jose Guillermo CEDENO LAURENT, ScD
Assistant Professor
Rutgers, The State University of New Jersey