The Emerging Adulthood Health Project
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Airway reactivity as assessed by airwave oscillometry
研究概览
简要总结
This study examines how electronic (e)-cigarette use impacts the body, by studying both users and non-users of e-cigarettes. Early evidence indicates that e-cig users experience adverse health effects. Results of this study may help policy-makers develop standards for different types of tobacco.
详细描述
PRIMARY OBJECTIVE:
Examine the short-term impacts of vaping on pulmonary and respiratory outcomes.
OUTLINE:
Current e-cigarette users will vape their own e-cigarette device ad libitum for 30 minutes; non-users will watch a neutral video for 30 minutes. Before and after the 30 minute vaping [video] session, participants will undergo the following assessments: computer-based spirometry testing, nitric oxide breath testing, airwave oscillometry, and an assessment of endothelial function. Participants will also undergo collection of blood.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •75 e-cig users and 75 never-users
- •No self-reported diagnosis of lung disease (e.g., coronavirus disease-2019 [COVID-19], pneumonia, cystic fibrosis)
- •No history of cardiac event or distress
- •Not currently breastfeeding, pregnant, or planning to become pregnant (e-cig users only; will be confirmed via pregnancy test)
排除标准
- 未提供
结局指标
主要结局
Airway reactivity as assessed by airwave oscillometry
时间窗: Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
Airway reactivity will be measured via Tremoflo, which is a well validated measurement of airway reactivity and provides curves of Resistance (R) and Reactance (X)
Respiratory functioning as assessed by a mobile Spirometry device
时间窗: Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
Spirometry will collect daily data from participants on the relationship between their forced expiratory volume and forced vital capacity (measured as FEV1/FVC).
Airway inflammation as assessed by exhaled nitric oxide
时间窗: Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
Exhaled nitric oxide will be measured in parts per billion (ppb)
Endothelial function
时间窗: Procedure will last approximately 20 minutes; the procedure will occur twice during the laboratory session (separated by approximately 90 minutes)
Endothelial function will be assessed with the EndoPAT device (unit of measurement = LnRHI).
次要结局
未报告次要终点
研究者
Megan Roberts
Principal Investigator
Ohio State University Comprehensive Cancer Center