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Secondhand Effects of E-Hookah Aerosol

Sponsor
University of California, Los Angeles (Other)
Overall Status
Recruiting
CT.gov ID
NCT04661683
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
3.7
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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 2 study visits (2-4 hours each): exposure to e-hookah aerosol delivered by a hookah smoking/vaping machine, and for comparison, before and after clean air. Non-invasive blood pressure and blood flow measurements will be taken before and after the exposure sessions.

Condition or Disease Intervention/Treatment Phase
  • Other: e-hookah aerosol
  • Other: clean air
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jun 25, 2021
Anticipated Primary Completion Date :
Oct 15, 2021
Anticipated Study Completion Date :
Oct 15, 2021

Arms and Interventions

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 30 mins

Other: clean air
Exposure to clean air for 30 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 30 mins

Other: clean air
Exposure to clean air for 30 mins.

Outcome Measures

Primary Outcome Measures

  1. Endothelial function [30 minutes]

    Change in Flow-Mediated Dilation, percent change pre to post exposure

  2. Arterial stiffness [30 minutes]

    change in pulse wave velocity, m/s-1 pre to post exposure

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 21-35 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

Locations

Site City State Country Postal Code
1 University of California, Los Angeles Los Angeles California United States 90095-8361

Sponsors and Collaborators

  • University of California, Los Angeles

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Dec 10, 2020
Last Update Posted:
Aug 12, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 12, 2021