Effects of Hookah Smoking on Blood Flow to the Heart, Muscle and Skin
1 other identifier
interventional
42
1 country
1
Brief Summary
This is a pilot study on acute effects of Hookah smoking on the sympathetic neural control of the human cardiovascular system. Hookah smoking is known to transiently increase blood pressure and heart rate while decreasing heart rate variability suggesting - but not proving - sympathetic mediation. Here the investigators will directly measure the acute effects of Hookah smoking on sympathetic nerve activity with microneurography (intraneural microelectrodes) and quantify associated regional changes in vasomotor tone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 30, 2014
CompletedFirst Posted
Study publicly available on registry
May 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedJanuary 13, 2020
November 1, 2015
3 years
April 30, 2014
January 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sympathetic nerve activity
Multi-unit recordings of sympathetic nerve activity will be obtained with single-use sterile tungsten microelectrodes inserted selectively into muscle or skin nerve fascicles of the peritoneal nerve.
At the initial study visit
Secondary Outcomes (1)
Myocardial contrast echocardiography
At the initial study visit
Other Outcomes (1)
Venous Occlusion Plethysmography
At the initial study visit
Study Arms (1)
Hookah smoking
EXPERIMENTALHealthy habitual Hookah smokers will undergo microneurography, myocardial contrast echocardiogram or venous occlusion plethysmography before and after Hookah smoking.
Interventions
Subjects will smoke waterpipe in a controlled research environment.
Eligibility Criteria
You may qualify if:
- to 39 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
You may not qualify if:
- Exhaled carbon monoxide level greater than 10 ppm\* as evidence of current or recent cigarette (excluded if smoked cigarette within 12 months) or Hookah smoking (excluded if smoked Hookah within past 72 hours)
- History of cardiopulmonary disease
- Use of any prescription medication with exception of oral contraceptive pills
- History of psychiatric illness
- History of neurologic disease
- BMI ≥ 35
- Evidence of any of the above by physical examination, ECG or echocardiogram
- Smoked cigarette in the past 12 months
- History of illicit drug use
- Pregnant
- Any other condition(s) deemed by the physician investigators that put subjects at risk for participating in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald G Victor, MD
Cedars-Sinai Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2014
First Posted
May 28, 2014
Study Start
March 1, 2013
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
January 13, 2020
Record last verified: 2015-11