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Active, not recruitingNCT04972513Updated Mar 23, 2026

Impact of E-cigarette Use on the Body

An observational study in Cigarette Smoking-Related Carcinoma, sponsored by Ohio State University Comprehensive Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 15 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-23.

Sponsored by Ohio State University Comprehensive Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
182
Ages
15 Years to 25 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Cigarette Smoking-Related Carcinoma
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In context

Lead sponsor

Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

E-cig (cigarette) users and non-users in Ohio

Eligibility criteria

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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
182 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

    Procedure: Biospecimen Collection · Procedure: Nitric Oxide Breath Test · Procedure: Oscillometry · Procedure: Spirometry · Other: Survey Administration · Procedure: Endothelial function

Interventions

  • ProcedureBiospecimen Collection

    Undergo collection of blood

  • ProcedureNitric Oxide Breath Test

    Undergo nitric oxide breath testing

  • ProcedureOscillometry

    Undergo airwave oscillometry

  • ProcedureSpirometry

    Undergo spirometry

  • OtherSurvey Administration

    Complete survey

  • ProcedureEndothelial function

    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 researchers measure

Primary outcomes

  1. Airway inflammation as assessed by exhaled nitric oxide

    Exhaled nitric oxide will be measured in parts per billion (ppb)

    Time frame: 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

    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)

    Time frame: 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

    Spirometry will collect daily data from participants on the relationship between their forced expiratory volume and forced vital capacity (measured as FEV1/FVC).

    Time frame: Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)

  4. Endothelial function

    Endothelial function will be assessed with the EndoPAT device (unit of measurement = LnRHI).

    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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Study locations

1 site
  • Ohio State University Comprehensive Cancer Center
    Columbus, Ohio 43210, United States
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References and documents

Related links

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04972513
Lead sponsor
Ohio State University Comprehensive Cancer Center
Responsible party
Megan Roberts (Principal Investigator, Ohio State University Comprehensive Cancer Center) — Principal investigator
First posted
Jul 22, 2021
Start date
Jul 22, 2021
Primary completion
Jun 29, 2022
Completion
Dec 31, 2026 (estimated)
Last update
Mar 23, 2026

Study contacts

Megan E Roberts, PhD
principal investigator · Ohio State University Comprehensive Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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