Clinical trial NCT02638194: Adverse Health Effects of Mainstream and Secondhand Hookah Smoke in NYC Hookah Bars
Official title: Adverse Health Effects of Mainstream and Secondhand Hookah Smoke in NYC Hookah Bars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
smoking
secondhand smoke
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2015-12-23
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Competent adult English speaking subjects
* Have used hookah in the past

Exclusion Criteria:

* Age \<21
* 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.

Primary outcomes:
measure: Changes in exhaled carbon dioxide measured by pulmonary function measure using a portable spirometer
timeFrame: subsequently after 2 hours of hookah smoking or smoke exposure and 24 hours after participants' visit hookah and wine bars.
measure: Changes in Heart Rate measured by a portable monitor worn during encounters
timeFrame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
measure: Changes in blood oxygenation levels measured by a pulse oximeter
timeFrame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
measure: Changes in measure of tobacco-related carcinogenic metabolite cotinine in saliva samples
timeFrame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
measure: Changes in measure of blood inflammatory marker endothelin
timeFrame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
measure: Changes in measure of blood inflammatory marker IL-10
timeFrame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
measure: Changes in measure of blood inflammatory marker IL-8
timeFrame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
measure: Changes in measure of blood inflammatory marker IL-6
timeFrame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
measure: Changes in measure of blood inflammatory marker CRP
timeFrame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
measure: Changes in measure of blood inflammatory marker IL-1a
timeFrame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
measure: Changes in measure of blood inflammatory marker IFN-g
timeFrame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
measure: Changes in measure of blood inflammatory marker TNF-a
timeFrame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
measure: Changes in measure of blood inflammatory marker GM-CSF
timeFrame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
measure: Changes in measure of blood inflammatory marker E-selectin
timeFrame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
measure: Changes in measure of blood inflammatory marker thrombomodulin
timeFrame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
measure: Changes in measure of blood inflammatory marker vWF
timeFrame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Secondary outcomes:
measure: Changes in Air Quality measured by an aethelometer
timeFrame: 2 hours spent at hookah bar
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Michael Weitzman, MD
role: PRINCIPAL_INVESTIGATOR
References: