RESEC: Respiratory Effects of E-Cigarettes in Obese Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Diffusion capacity
研究概览
简要总结
To determine vaping behaviors and respiratory function in obese and nonobese youth e-cigarette users.
详细描述
The investigators hypothesize that obese youth e-cigarette users will have increased e-cigarette use that will worsen respiratory function. The approach will involve a clinical trial where vaping behaviors (using puff topography) and respiratory function (spirometry, plethysmography, and diffusion capacity) will be assessed while participants vape with their own e-cigarette and, on a separate visit, with the VUSE e-cigarette.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a current e-cigarette user (≥1 vaping bout daily) for at least the past 3 months,
- •21-25 years old,
- •willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions,
- •willing to complete five lab visits lasting up to 4 hours each,
- •able to read and speak English,
- •willing to provide informed consent.
排除标准
- •self-reported diagnosis of lung disease including asthma or cystic fibrosis
- •history of cardiac event or distress within the past 3 months
- •history of metabolic disease including thyroid disease or diabetes
- •history of orthopedic or neuromuscular problems that preclude exercise
- •currently pregnant (determined using urine pregnancy test), planning to become pregnant, delivered a child in the past 6 weeks even if not breastfeeding, or currently breastfeeding
- •use of other tobacco products >10 days in the past month
- •current marijuana use >10 times per month
- •currently engaging in a vaping cessation attempt
- •) competitive athlete or individual currently engaged in an exercise training program involving 420min or more (moderate intensity aerobic activity) or 210 min or more (vigorous intensity aerobic activity) per week with the goal of participating in a competitive event or marathon, triathlon, etc. Participants who are engaged in usual physical activity (e.g., walking dog, biking to work, etc.) but not engaged in a "structured exercise training program" will not be excluded.
- •plans to leave the Columbus or central Ohio region within the next year.
研究组 & 干预措施
Vaping
All participants will undergo two vaping sessions: one using their own device and one using the study device
干预措施: ECIG Vuse (Other)
Vaping
All participants will undergo two vaping sessions: one using their own device and one using the study device
干预措施: ECIG own (Other)
结局指标
主要结局
Diffusion capacity
时间窗: Change from 0 to 35 minutes
DLCO will be completed before and after a 35 min vaping session
Forced expiratory volume in 1 second
时间窗: Change from 0 to 35 minutes
Spirometry will be completed before and after a 35 min vaping session
Average Puff duration
时间窗: 35 minutes
E-cig puff topography data collection for abuse liability
Functional residual capacity
时间窗: Change from 0 to 35 minutes
Plethymosgraphy will be completed before and after a 35 min vaping session
Airway resistance
时间窗: Change from 0 to 35 minutes
Plethymosgraphy to measure airway resistance (Raw) will be completed before and after a 35 min vaping session
Puff count
时间窗: 35 minutes
E-cig puff topography data collection for abuse liability
Average Puff volume
时间窗: 35 minutes
E-cig puff topography data collection for abuse liability
次要结局
- Tiffany-Drobes Questionnaire of Smoking Urges(Change from 0 to 35 minutes)
- Respiratory health questionnaire(Change from 0 to 35 minutes)
- Exhaled carbon monoxide(Change from 0 to 35 minutes)
研究者
Dharini Bhammar
Assistant Professor
Ohio State University Comprehensive Cancer Center