- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04972513
Impact of E-cigarette Use on the Body
The Emerging Adulthood Health Project
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVE:
Examine the short-term impacts of vaping on pulmonary and respiratory outcomes.
OUTLINE:
Current e-cigarette users will vape their own e-cigarette device ad libitum for 30 minutes; non-users will watch a neutral video for 30 minutes. Before and after the 30 minute vaping [video] session, participants will undergo the following assessments: computer-based spirometry testing, nitric oxide breath testing, airwave oscillometry, and an assessment of endothelial function. Participants will also undergo collection of blood.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Prevention (survey, breathe tests, biospecimen collection)
Participants undergo computer-based spirometry testing, nitric oxide breath testing, airwave oscillometry, and an assessment of endothelial function.
Participants will undergo collection of blood.
Current e-cigarette users also vape their own e-cigarette device for 30 minutes.
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Undergo collection of blood
Complete survey
Undergo nitric oxide breath testing
Undergo airwave oscillometry
Undergo spirometry
Endothelial function will be assessed with the EndoPAT device, which measures changes in pressure from sensors placed on the fingertip
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Airway inflammation as assessed by exhaled nitric oxide
Time Frame: Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
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Exhaled nitric oxide will be measured in parts per billion (ppb)
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Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
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Airway reactivity as assessed by airwave oscillometry
Time Frame: Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
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Airway reactivity will be measured via Tremoflo, which is a well validated measurement of airway reactivity and provides curves of Resistance (R) and Reactance (X)
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Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
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Respiratory functioning as assessed by a mobile Spirometry device
Time Frame: Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
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Spirometry will collect daily data from participants on the relationship between their forced expiratory volume and forced vital capacity (measured as FEV1/FVC).
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Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
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Endothelial function
Time Frame: Procedure will last approximately 20 minutes; the procedure will occur twice during the laboratory session (separated by approximately 90 minutes)
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Endothelial function will be assessed with the EndoPAT device (unit of measurement = LnRHI).
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Procedure will last approximately 20 minutes; the procedure will occur twice during the laboratory session (separated by approximately 90 minutes)
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Collaborators and Investigators
Investigators
- Principal Investigator: Megan E Roberts, PhD, Ohio State University Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSU-20320
- NCI-2021-06438 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.