Impact of E-cigarette Use on the Body (NCT04972513) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Impact of E-cigarette Use on the Body
United States182 participantsStarted 2021-07-22
Plain-language summary
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.
Who can participate
Age range
15 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is specifically looking at things like airway inflammation, lung function, and blood vessel health in people who use e-cigarettes — given my own smoking or vaping history, is participating in this kind of observational research something my doctor thinks would be appropriate for me to consider?
2Since this trial is listed as 'active, not recruiting,' does my doctor know whether enrollment is truly closed or whether there are any remaining spots, and if it is closed, are there similar studies I could look into instead?
3The trial measures airway inflammation using exhaled nitric oxide and lung function using a mobile spirometry device — are any of these tests already part of my regular care, and would joining a study like this give me access to information about my lung health that I wouldn't otherwise get?
4Since this study doesn't appear to be testing a new treatment but is instead observing the effects of e-cigarette use on the body, what does my doctor think the practical takeaway could be for me personally, especially regarding any risks to my airways or cardiovascular health?
5Given that this research is focused on cigarette smoking-related cancer risk, should I be talking to my doctor about whether my current or past vaping or smoking habits put me at a level of risk that warrants more active screening or monitoring, regardless of whether I join this study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Airway inflammation as assessed by exhaled nitric oxide
Timeframe: Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
2
Airway reactivity as assessed by airwave oscillometry
Timeframe: Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
3
Respiratory functioning as assessed by a mobile Spirometry device
Timeframe: Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
4
Endothelial function
Timeframe: Procedure will last approximately 20 minutes; the procedure will occur twice during the laboratory session (separated by approximately 90 minutes)
Trial details
NCT IDNCT04972513
SponsorOhio State University Comprehensive Cancer Center