Examining Heavy Metal Exposure and Respiratory Health in Young Adult Electronic Cigarette Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Heavy metal concentration in the saliva of e-cigarette users
研究概览
简要总结
This study investigates heavy metal exposure in young adults who use electronic cigarettes.
详细描述
PRIMARY OBJECTIVES:
I. Identify and quantify heavy metals (HM) concentration in the saliva of e-cigarette users.
II. Examine changes in pulmonary functioning and HM concentration pre/post vaping.
III. Examine the association between vaping intensity and HM concentration in the saliva of e-cigarette users.
OUTLINE: This is an observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-29 years
- •Established electronic cigarette (EC) user (participant uses ECs on a daily/weekly basis [used on ≥ 5 days in past 30-days] for the past 3 months)
- •Willing to abstain from nicotine for at least 12 hours before the laboratory visit
- •Willing to not eat food or drink water/beverages for at least 30 minutes before the laboratory visit [required for salivary collection]
- •Utilize 4th generation EC products (pod-mod or disposable EC products; e.g., JUUL, Hyde)
- •Must be able to read and write in English
排除标准
- •Recently COVID-19+ (defined as a positive test in the past 30 days) or a recent COVID-19 hospitalization (within the past 6 months)
- •Attempting to quit the use of ECs
- •Is pregnant, planning on becoming pregnant and/or breastfeeding [will be verified using a urine pregnancy test]
- •Self-reported severe or significant psychological and/or psychiatric conditions [e.g., not currently receiving treatment/medication; only past and/or stable conditions will be allowed]
- •A history of cardiac events and/or distress within the past 3 months
- •Diagnosed with a chronic, serious lung disease or current infection (e.g., pneumonia, pulmonary edema)
- •Are deaf, hard of hearing, or have a severe motor disability
研究组 & 干预措施
Observational
Participants vape their own electronic cigarette device as much or as little as they like over 30 minutes on study. Participants also undergo saliva sample collection, spirometry to measure respiratory function, and complete questionnaires.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Heavy metal concentration in the saliva of e-cigarette users
时间窗: Baseline, Immediately Following Vaping Session
Identify and quantify HM concentrations in the saliva among all participants in the sample before and after their 30 minute vaping session.
Spirometry to Measure the Change From Baseline in Forced Vital Capacity (FVC)
时间窗: Baseline, Immediately Following Vaping Session
Participants will complete spirometry (a pulmonary function test) before and immediately after the completion of the 30 minute vaping session.
Spirometry to Measure the Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
时间窗: Baseline, Immediately Following Vaping Session
Participants will complete spirometry (a pulmonary function test) before and immediately after the completion of the 30 minute vaping session.
E-cigarette puffing behavior
时间窗: Up to 30 minutes
E-cigarette puffing behavior will be measured with a topography device that records frequency, duration, and flow rate of e-cigarette puffs. These measures are combined to inform the overall measure of e-cigarette puffing behavior.
次要结局
未报告次要终点
研究者
Alayna Tackett
Principal Investigator
Ohio State University Comprehensive Cancer Center