Impact of E-cigarette Use on the Body

N/AActive Not RecruitingNCT04972513

Ohio State University Comprehensive Cancer Center182 enrolled

Overview

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.

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

OBSERVATIONAL

Enrollment

182

Conditions

Cigarette Smoking-Related Carcinoma

Interventions

Biospecimen CollectionPROCEDURE

Undergo collection of blood

Nitric Oxide Breath TestPROCEDURE

Undergo nitric oxide breath testing

OscillometryPROCEDURE

Undergo airwave oscillometry

Eligibility

Sex: ALLMin age: 15 YearsMax age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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)

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)

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)

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)

Data from ClinicalTrials.gov

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