E-Cigarettes and SNA

December 3, 2021 updated by: Holly R Middlekauff, University of California, Los Angeles

The Effects of Electronic Cigarettes on Sympathetic Nerve Activity and Oxidative Stress

Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and sham control, on sympathetic nerve activity and markers of oxidative stress.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will use an electronic cigarette on 3 occasions: 1) with nicotine, 2) without nicotine, 3) sham control, and measures of autonomic tone, including heart rate variability (HRV) and sympathetic nerve activity (MSNA: microneurography), and oxidative stress will be measured pre and post exposure.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCaliforniaLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy

Exclusion Criteria:

  • Cardiac disease
  • Respiratory disease
  • Diabetes mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nicotine
use of an e-cigarette filled with liquid with nicotine
Other: one time exposure to e-cig with nicotine
one time exposure to e-cigarette vapor with nicotine
Experimental: no nicotine
Use of an e-cigarette filled with liquid without nicotine
Other: One time exposure to e-cigarette without nicotine
One time exposure to e-cig without nicotine
Sham Comparator: sham comparator
Use of empty e-cigarette (sham control)
Other: one time exposure to empty e-cigarette
one time exposure to empty e-cigarette (sham control)
Other Names:
  • sham control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate variability
Time Frame: 10 minutes after exposure
Heart rate variability is a measure of autonomic tone
10 minutes after exposure
Paraoxonase
Time Frame: less than 1 hour after exposure
plasma oxidative stress
less than 1 hour after exposure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle sympathetic nerve activity
Time Frame: 10 minutes after exposure
Muscle sympathetic nerve activity (MSNA)
10 minutes after exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

March 24, 2016

First Posted (Estimate)

March 31, 2016

Study Record Updates

Last Update Posted (Actual)

December 20, 2021

Last Update Submitted That Met QC Criteria

December 3, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-000731

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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