Clinical Trials Directory

Trials / Completed

CompletedNCT04395274

Young Adult EC Use and Respiratory Outcomes

Status
Completed
Phase
Study type
Observational
Enrollment
115 (actual)
Sponsor
Ohio State University Comprehensive Cancer Center · Academic / Other
Sex
All
Age
18 Years – 25 Years
Healthy volunteers
Accepted

Summary

E-cigarette (EC) use continues to increase among youth, and EC may be detrimental to youth respiratory health. Public health officials and the Food and Drug Administration (FDA) can now regulate ECs. The proposed study uses naturalistic assessments called ecological momentary assessment (EMA) to understand how ECs use may impact the respiratory health of youth and young adult users compared to never-using peers.

Detailed description

Using a prospective longitudinal design, 150 youth and young adults aged 18-25 years (100 exclusive-EC users; 50 never-users) will complete 5 sessions (baseline, 3-,6-, 9-, and 12-months). Sessions will include naturalistic measures such as measures of respiratory health, questionnaires, and nasal epithelial lining fluid (NELF) nasal samples. To assess acute changes in pulmonary functioning related to tobacco product use, participants will complete twice daily EMA and home-based spirometry for the 2 weeks following the Day 1 session and the 2 weeks prior to each follow-up zoom session. Never-users will participate in a brief 15-30-minute individual interview consisting of questions related to reasons for never-EC use and other protective factors that will be used to build future prevention messaging.

Conditions

Timeline

Start date
2021-12-15
Primary completion
2024-02-21
Completion
2024-02-21
First posted
2020-05-20
Last updated
2024-12-12
Results posted
2024-12-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04395274. Inclusion in this directory is not an endorsement.