Hookah Smoking Clinical Trial
Official title:
Effects of Hookah Smoking on Blood Flow to the Heart, Muscle and Skin
NCT number | NCT02147665 |
Other study ID # | Pro00031150 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2013 |
Est. completion date | March 2016 |
Verified date | November 2015 |
Source | Cedars-Sinai Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 39 Years |
Eligibility |
Inclusion Criteria: - 18 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Cedars-Sinai Medical Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Cedars-Sinai Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Venous Occlusion Plethysmography | Lower leg blood flow will be measured with standard venous occlusion plethysmography. | At the initial study visit | |
Primary | 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 | Myocardial contrast echocardiography | Myocardial contrast echocardiography will be used to measure regional myocardial perfusion (i.e. capillary blood volume) and coronary flow reserve. | At the initial study visit |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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