Impact of E-cigarette Use on the Body

Active, not recruiting

• Conditions: Cigarette Smoking-Related Carcinoma
• Interventions: Procedure: Biospecimen Collection; Procedure: Nitric Oxide Breath Test; Procedure: Oscillometry; Procedure: Spirometry; Other: Survey Administration; Procedure: Endothelial function

• Registration Number: NCT04972513
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief 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.

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 Timeline

• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-07-19
• Study Start: 2021-07-22
• Study First Posted: 2021-07-22
• Primary Completion: 2022-06-29
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-31
• Last Update Posted: 2025-01-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 182

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prevention (survey, breathe tests, biospecimen collection)	Oscillometry	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.
Prevention (survey, breathe tests, biospecimen collection)	Spirometry	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.
Prevention (survey, breathe tests, biospecimen collection)	Endothelial function	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.
Prevention (survey, breathe tests, biospecimen collection)	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.
Prevention (survey, breathe tests, biospecimen collection)	Nitric Oxide Breath Test	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.
Prevention (survey, breathe tests, biospecimen collection)	Survey Administration	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.

Primary Outcome Measures

Name	Time	Method
Airway reactivity as assessed by airwave oscillometry	Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)	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)
Respiratory functioning as assessed by a mobile Spirometry device	Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)	Spirometry will collect daily data from participants on the relationship between their forced expiratory volume and forced vital capacity (measured as FEV1/FVC).
Airway inflammation as assessed by exhaled nitric oxide	Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)	Exhaled nitric oxide will be measured in parts per billion (ppb)
Endothelial function	Procedure will last approximately 20 minutes; the procedure will occur twice during the laboratory session (separated by approximately 90 minutes)	Endothelial function will be assessed with the EndoPAT device (unit of measurement = LnRHI).

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States