Adverse Health Effects of Mainstream and Secondhand Hookah Smoke in NYC Hookah Bars
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Changes in measure of tobacco-related carcinogenic metabolite cotinine in saliva samples
研究概览
简要总结
The primary purpose of this study is to examine the health effects of mainstream and secondhand hookah (i.e. water pipe) smoke on pulmonary and cardiovascular functions as well as serum levels of inflammatory biomarkers. Investigators would like to demonstrate that inhalation of both mainstream and secondhand smoke generated by hookah produces adverse pulmonary and cardiovascular effects and alterations in serum levels of inflammatory biomarkers.
详细描述
A total of 20 participants are going to be enrolled in this study; 10 participants smoke hookah and 10 participants are exposed to second hand hookah smoke for 2 hours in NYC hookah bars. Subjects in the control group will also be paired as they were for the hookah bar visit but will visit a control location, where they will be asked to consume a similar amount of food and drink at a wine bar. Pulmonary function, cardiovascular changes, and blood and urine markers of inflammatory mediators before, immediately after and 24 hours after the participants' visits to hookah bars and wine bars will be examined. Air quality monitoring will also be performed at the hookah bar and at the control location. Physiological changes will be assessed by measuring pulmonary function, blood pressure, heart rate, and blood oxygenation status. To determine the extent of tobacco exposure and associated inflammatory changes from secondhand hookah smoke, investigators will measure blood inflammatory biomarkers, oxidative stress, gene expression, tobacco-related carcinogenic metabolites, and exhaled carbon dioxide levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Competent adult English speaking subjects
- •Have used hookah in the past
排除标准
- •Pregnancy
- •Current cigarette smokers
- •Has pulmonary disease, such as asthma or Chronic Obstructive Pulmonary Disease (COPD)
- •Subjects are unable to give voluntary informed consent because they are non English speaking, are unable to read or write, or any other impediments that prohibits giving written informed consent
- •Recent nasal surgery (within 6 months)
- •History of bleeding or other blood related disorder.
结局指标
主要结局
Changes in measure of tobacco-related carcinogenic metabolite cotinine in saliva samples
时间窗: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker TNF-a
时间窗: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker thrombomodulin
时间窗: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker IL-10
时间窗: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker IL-8
时间窗: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker IL-1a
时间窗: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in Heart Rate measured by a portable monitor worn during encounters
时间窗: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in blood oxygenation levels measured by a pulse oximeter
时间窗: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker IFN-g
时间窗: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in exhaled carbon dioxide measured by pulmonary function measure using a portable spirometer
时间窗: subsequently after 2 hours of hookah smoking or smoke exposure and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker E-selectin
时间窗: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker endothelin
时间窗: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker IL-6
时间窗: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker CRP
时间窗: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker GM-CSF
时间窗: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker vWF
时间窗: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
次要结局
- Changes in Air Quality measured by an aethelometer(2 hours spent at hookah bar)