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Completed

NCT Number: NCT02638194

Adverse Health Effects of Mainstream and Secondhand Hookah Smoke in NYC Hookah Bars

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active smoking of Tobacco Hookah for 2 hours

Other

Exposure to tobacco hookah second hand smoke

Other

Visit a win bar

Other

Participants will visit a wine bar for food and/or drinks

Primary outcomes

  1. Changes in exhaled carbon dioxide measured by pulmonary function measure using a portable spirometer

    Time frame: subsequently after 2 hours of hookah smoking or smoke exposure and 24 hours after participants' visit hookah and wine bars.

  2. Changes in Heart Rate measured by a portable monitor worn during encounters

    Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.

  3. Changes in blood oxygenation levels measured by a pulse oximeter

    Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.

  4. Changes in measure of tobacco-related carcinogenic metabolite cotinine in saliva samples

    Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.

  5. Changes in measure of blood inflammatory marker endothelin

    Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.

  6. Changes in measure of blood inflammatory marker IL-10

    Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.

  7. Changes in measure of blood inflammatory marker IL-8

    Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.

  8. Changes in measure of blood inflammatory marker IL-6

    Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.

  9. Changes in measure of blood inflammatory marker CRP

    Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.

  10. Changes in measure of blood inflammatory marker IL-1a

    Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.

  11. Changes in measure of blood inflammatory marker IFN-g

    Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.

  12. Changes in measure of blood inflammatory marker TNF-a

    Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.

  13. Changes in measure of blood inflammatory marker GM-CSF

    Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.

  14. Changes in measure of blood inflammatory marker E-selectin

    Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.

  15. Changes in measure of blood inflammatory marker thrombomodulin

    Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.

  16. Changes in measure of blood inflammatory marker vWF

    Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.

Secondary outcomes

  1. Changes in Air Quality measured by an aethelometer

    Time frame: 2 hours spent at hookah bar

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Dec 23, 2015
Registry last updated
Dec 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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