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Secondhand Effects of E-Hookah Aerosol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04661683
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : September 6, 2022
Sponsor:
Information provided by (Responsible Party):
Mary Rezk-Hanna, PhD, University of California, Los Angeles

Study Description
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Brief Summary:
In the United States, exposure to secondhand smoke accounts for greater than 35,000 deaths annually from cardiovascular disease in never-smokers. Electronic (e-) hookahs are a new category of vaping devices gaining popularity among youth. While more is known on the acute effects of active hookah smoking and the literature is emerging on active e-hookah vaping, virtually nothing is known about the acute cardiovascular effects of secondhand exposure to e-hookah aerosol. The study aims to examine the acute effects of secondhand exposure of e-hookah aerosol on endothelial and vascular function. Eligible volunteers will be invited to participate in a total of 3 study visits (2-3 hours each): e-hookah aerosol exposure, charcoal-heated hookah smoke exposure (both delivered by a hookah smoking/vaping machine) and smoke-free room air. Non-invasive blood pressure and blood flow measurements will be taken before and after the exposure sessions.

Condition or disease Intervention/treatment Phase
Hookah Smoking Secondhand Aerosol Vascular Stiffness Vaping Other: e-hookah aerosol Other: clean air Other: Charcoal-heated hookah smoke Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Investigating Secondhand Effects of E-Hookah Aerosol
Actual Study Start Date : June 25, 2021
Estimated Primary Completion Date : October 15, 2023
Estimated Study Completion Date : October 15, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Peripheral Endothelial Function
Brachial artery flow-mediated dilation will be used to measure endothelial function
 Other: e-hookah aerosol
Exposure to secondhand aerosol delivered by an e-hookah vaping machine for 60 mins

Other: clean air
Exposure to clean air for 60 mins.

Other: Charcoal-heated hookah smoke
Exposure to secondhand smoke delivered by a hookah vaping machine for 60 mins
Experimental: Central Arterial Stiffness
Pulse wave velocity will be used to measure arterial stiffness.
 Other: e-hookah aerosol
Exposure to secondhand aerosol delivered by an e-hookah vaping machine for 60 mins

Other: clean air
Exposure to clean air for 60 mins.

Other: Charcoal-heated hookah smoke
Exposure to secondhand smoke delivered by a hookah vaping machine for 60 mins


Outcome Measures
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Primary Outcome Measures :
  1. Endothelial function [ Time Frame: 30 minutes ]
    Change in Flow-Mediated Dilation, percent change pre to post exposure

  2. Arterial stiffness [ Time Frame: 30 minutes ]
    change in pulse wave velocity, m/s-1 pre to post exposure


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 21-49 years old
  • Never a smoker: do not use any tobacco products or nicotine delivery systems, including cigarettes, cigars (traditional and filtered), cigarillos, hookah, smokeless tobacco (i.e., loose snus, moist snuff, dip, spit, or chewing tobacco), pipe tobacco, snus pouches, dissolvable tobacco or vaping.
  • no evidence of cardiopulmonary disease by history/physical
  • blood pressure (BP) < 140/90 mmHg
  • resting heart rate (HR) < 100 bpm
  • BMI >18 or < 30kg•m2
  • no prescription medication
  • No exposure to environmental tobacco smoke for at least one week prior to the study date.

Exclusion Criteria:

  • exhaled carbon monoxide >6 ppm
  • (+) pregnancy test
  • other conditions deemed unsafe to participate, such as breastfeeding
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04661683


Contacts
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Contact: Mary Rezk-Hanna, PhD 310-206-8654 MRHanna@mednet.ucla.edu

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095-8361
Contact: Primadya Sakti, B.A.    310-562-4348    psakti@sonnet.ucla.edu   
Contact: Amanda Adolfo, B.S    310-562-4348    abadolfo@sonnet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
More Information
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Responsible Party: Mary Rezk-Hanna, PhD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04661683    
Other Study ID Numbers: 20-001570
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: September 6, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Charcoal
Antidotes
Protective Agents
Physiological Effects of Drugs