Effects of Hookah (Waterpipe) Smoking on Blood Vessel Function

February 2, 2021 updated by: Florian Rader, Cedars-Sinai Medical Center

Effects of Hookah Smoking on Vascular Regulation: Novel Insight Into Endothelial Function

The purpose of this study is to assess the acute effects of Hookah (waterpipe) smoking on blood vessel function. Hookah smoking has been shown to immediately increase blood pressure and heart rate which could result in damage in the inner lining of the body's blood vessels.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The investigators will measure acute endothelial and vascular changes before and after a 30-minute Hookah smoking session in a controlled laboratory environment to: (1) Determine the acute effects of Hookah smoking on large-vessel endothelial vasodilator function measured by brachial artery flow mediated dilation; (2) Determine the acute effects of Hookah smoking on micro-vessel endothelial function as measured by reactive hyperemia peripheral arterial tonometry; (3) Determine the acute effects of Hookah smoking on pulse wave velocity and aortic pressure waveform measured by pulse tonometry.

Study Type

Interventional

Enrollment (Anticipated)

58

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, 90048
        • Cedars-Sinai Medical Center

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

18 years to 29 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 to 29 years of age
  • Habitual Hookah smoker defined as having smoked Hookah >=12 times in the past 12 months
  • Have not smoked cigarettes within the past 12 months

Exclusion Criteria:

  • History of cardiopulmonary, diabetes, dyslipidemia or psychiatric disease
  • Exhaled carbon monoxide level >10 ppm
  • BP < 140/90 mmHg
  • BMI <18.5 or > 30 kg•m2
  • Resting heart rate > 100 beats/min
  • Taking prescription medication
  • History of illicit drug use
  • Pregnant

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hookah smoking
Healthy habitual Hookah smokers will undergo brachial artery flow mediated dilation, reactive hyperemia peripheral arterial tonometry or pulse tonometry before and after Hookah smoking.
Other: Hookah smoking
ad lib hookah smoking for 30 minutes in a controlled laboratory environment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brachial artery flow-mediated dilation
Time Frame: change from baseline to immediately after smoking
change from baseline to immediately after smoking

Secondary Outcome Measures

Outcome Measure
Time Frame
Reactive hyperemia peripheral arterial tonometry
Time Frame: change from baseline to immediately after smoking
change from baseline to immediately after smoking

Other Outcome Measures

Outcome Measure
Time Frame
Pulse wave velocity
Time Frame: change from baseline to immediately after smoking
change from baseline to immediately after smoking
aortic pressure waveform
Time Frame: change from baseline to immediately after smoking
change from baseline to immediately after smoking

Collaborators and Investigators

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

Sponsor

Cedars-Sinai Medical Center

Collaborators

University of California, Los Angeles
University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 1, 2015

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

August 2, 2018

First Posted (Actual)

August 6, 2018

Study Record Updates

Last Update Posted (Actual)

February 4, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00036547

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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