Young Adult EC Use and Respiratory Outcomes

Ohio State University Comprehensive Cancer Center1 个研究点分布在 1 个国家目标入组 115 人开始时间: 2021年12月15日最近更新: 2024年12月12日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Ohio State University Comprehensive Cancer Center
入组人数: 115
试验地点: 1
主要终点: Spirometry to Measure the Change From Baseline in Forced Vital Capacity (FVC)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 25 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•own a smartphone and willing to add study EMA and spirometry application to it.
•a current exclusive-EC user (endorse ≥weekly use over the past 3 months) and report never trying OTPs
•between the ages of 18-25 years old at the time of enrollment
•read and speak English
•willing to complete five, 2-week periods of daily EMA and home-based spirometry
•never-users must indicate never trying any tobacco product to be eligible for enrollment

排除标准

•self-reported diagnosis of lung disease including cystic fibrosis or chronic obstructive pulmonary disease; we will not exclude youth who have asthma, but will incorporate this as a covariate during analyses
•unstable or significant psychiatric conditions (past and stable conditions will be allowed)
•history of cardiac event or distress within the past 3 months
•are currently pregnant, planning to become pregnant, or breastfeeding
•are blind, severely visually impaired, deaf, hard of hearing, or have a severe motor disability