Understanding the Impact of Cartridge-Based Electronic Cigarettes and Generated Aerosols on Cardiopulmonary Health
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change in Peak oxygen consumption (VO2 peak)
研究概览
简要总结
Over the last decade, e-cigarettes have become increasingly popular, due to their promotion as a healthy alternative to traditional tobacco cigarettes. However, there are large discrepancies of knowledge in understanding how these e-cigarettes affect the user's health. The overall goal of this study is to evaluate the impact of e-cigarettes usage on user's cardiopulmonary health
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •E-Cigarette group:
- •21 years of age or older
- •Used e-cigarettes (≥3 times/week for ≥3 months)
- •Non e-cigarette group
- •● 21 years of age or older
排除标准
- •20 years old and younger
- •Use of cigarettes for 15 days or more in the past 60 days
- •Use of other tobacco products (cigars, hookah, smokeless) weekly or more frequently in the past 60 days
- •Use of marijuana or any illicit or prescription drugs for non-medical use weekly or more frequently in the past 60 days
- •Known allergy to propylene glycol or vegetable glycerin
- •Evidence of cardiovascular, pulmonary, renal, hepatic, metabolic, or cerebral diseases
- •Disorder or use of medication that affects cardiopulmonary health
- •Evidence of pregnancy or current nursing
研究组 & 干预措施
E-cigarette liquid type 1
Participants will be instructed to use at least one study product daily in place of their own e-cigarettes during the intervention period.
干预措施: Tobacco flavored liquid type 1 (Drug)
E-cigarettes liquid type 2
Participants will be instructed to use at least one study product daily in place of their own e-cigarettes during the intervention period.
干预措施: Tobacco flavored liquid type 2 (Drug)
结局指标
主要结局
Change in Peak oxygen consumption (VO2 peak)
时间窗: Change from baseline to 2 weeks
Participants' peak oxygen consumption (VO2 peak) will be measured using a standardized exercise capacity test performed on a stationary bike.
Change in Expiratory Volume
时间窗: Change from baseline to 2 weeks
Participants expiratory volume will be measured through spirometry using a pulmonary function device.
次要结局
- Change in Maximal microvascular dilation(Change from baseline to 2 weeks)
- Change in Skeletal muscle O2 utilization(Change from baseline to 2 weeks)