Bystanders' Exposure to Electronic Cigarette Aerosol in Confined Settings (NCT04140617) | Clinical Trial Compass
CompletedNot Applicable
Bystanders' Exposure to Electronic Cigarette Aerosol in Confined Settings
Spain2 participantsStarted 2019-07-01
Plain-language summary
Objective of this study is to investigate the bystanders' exposure to e-cigarette emissions in controlled conditions in confined settings.
Design: a cross-sectional experimental study developed in two settings: a car and a room. The experimental study will be replicated 5 times in each setting.
Three volunteers will be enrolled: 2 non-users of e-cigarettes (and non-smokers of any tobacco or nicotine product) and 1 exclusive e-cigarette user (not using any other tobacco or nicotine product) to create aerosol.
In brief, during the experimental session the e-cigarette user will be asked to use electronic cigarette during 30 minutes and two non-smokers will sit next to the user.
Individual exposure will be measured through saliva sample collection and irritation symptoms questionnaire to be collected 4 times: before exposure, just after 30 minutes of exposure, 30 minutes after the end of exposure and 3 hours after the end of exposure. Moreover, environmental exposure will be measured prior (5 min), during (30 min) and after (5 min) the exposure; particulate matter and airborne nicotine concentrations will be measure for this purpose.
Who can participate
Age range
10 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:
For e-cigarette non-users
* Adult (18 years old and above)
* Non-e-cigarette user (never user or more than 6 months former e-cigarette user)
* Non-smoker or user of any kind of tobacco/nicotine product (never or ex-smoker for \>6 months)
* Not being regularly exposed to cigarettes or e-cigarettes at home or other settings
For the e-cigarette user
* Adult (18 years old and above)
* Daily user of e-cigarettes (at least 2 months)
* Non-user of any other tobacco/nicotine products for at least 2 months
Exclusion Criteria:
For all participants:
* Pregnancy or breastfeeding
* Ongoing or recent illness (\<4 weeks prior to the study)
* Acute or chronic condition or disease (diabetes, asthma, COPD, congenital heart disease, arrhythmia, hypertension or other)
* Any type of medication (\<2 weeks prior to the study)
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Change in airborne nicotine concentration (mg/m3)
Timeframe: Pre-exposure (5 minutes*5 replications in two settings: car and room); concentration during the exposure (30 minutes*5 replications in two settings: car and room); Post-exposure (5 minutes*5 replications in two settings: car and room)