Secondhand Effects of Hookah (i.e., Waterpipe) Smoke and Aerosol (NCT04661683) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Secondhand Effects of Hookah (i.e., Waterpipe) Smoke and Aerosol
United States12 participantsStarted 2021-06-25
Plain-language summary
In the United States, secondhand smoke is the third leading preventable cause of death. Flavored hookah (waterpipe) tobacco smoking, a highly social activity common in hookah bars, is a key source of SHS exposure. While smoke-free air laws have decreased exposure to secondhand smoke, the majority of laws do not include hookah smoking. Thus, as a social outlet for youth and young adults, hookah smoke exposure may harm non-smokers, including women of reproductive age or pregnant, hookah bar workers, children, and individuals with heart and lung disease. While more is known on the acute effects of active hookah smoking and the literature is emerging on active e-hookah vaping, little is known about the acute vascular effects of secondhand exposure to hookah smoke and aerosol. The study aims to examine the acute effects of secondhand exposure of hookah smoke and aerosol on endothelial and vascular function. Eligible volunteers will be invited to participate in a total of 3 study visits (2-3 hours each): e-hookah aerosol exposure, charcoal-heated hookah smoke exposure and smoke-free room air. Non-invasive blood pressure and blood flow measurements will be taken before and after the exposure sessions.
Who can participate
Age range
21 Years – 49 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:
* 21-49 years old
* Never a smoker: do not use any tobacco products or nicotine delivery systems, including cigarettes, cigars (traditional and filtered), cigarillos, hookah, smokeless tobacco (i.e., loose snus, moist snuff, dip, spit, or chewing tobacco), pipe tobacco, snus pouches, dissolvable tobacco or vaping.
* no evidence of cardiopulmonary disease by history/physical
* blood pressure (BP) \< 140/90 mmHg
* resting heart rate (HR) \< 100 bpm
* BMI \>18 or \< 30kg•m2
* no prescription medication
* No exposure to environmental tobacco smoke for at least one week prior to the study date.
Exclusion Criteria:
* exhaled carbon monoxide \>6 ppm
* (+) pregnancy test
* other conditions deemed unsafe to participate, such as breastfeeding
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
Flow-Mediated Dilation (FMD)
Timeframe: Pre- and post- the 60-minute exposure sessions
2
Arterial stiffness
Timeframe: Pre- and post- the 60-minute exposure sessions