Impact of E-cigarette Use on the Body

NCT ID: NCT04972513

Last Updated: 2025-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

182 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-22

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cigarette Smoking-Related Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Nitric Oxide Breath Test

Intervention Type PROCEDURE

Undergo nitric oxide breath testing

Oscillometry

Intervention Type PROCEDURE

Undergo airwave oscillometry

Spirometry

Intervention Type PROCEDURE

Undergo spirometry

Survey Administration

Intervention Type OTHER

Complete survey

Endothelial function

Intervention Type PROCEDURE

Endothelial function will be assessed with the EndoPAT device, which measures changes in pressure from sensors placed on the fingertip

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biospecimen Collection

Undergo collection of blood

Intervention Type PROCEDURE

Nitric Oxide Breath Test

Undergo nitric oxide breath testing

Intervention Type PROCEDURE

Oscillometry

Undergo airwave oscillometry

Intervention Type PROCEDURE

Spirometry

Undergo spirometry

Intervention Type PROCEDURE

Survey Administration

Complete survey

Intervention Type OTHER

Endothelial function

Endothelial function will be assessed with the EndoPAT device, which measures changes in pressure from sensors placed on the fingertip

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Megan Roberts

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Megan E Roberts, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2021-06438

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-20320

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.