- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03625440
Acute Effects of Waterpipe Smoking on Cognitive Measures and Cardiorespiratory Parameters
Title: Acute effects of waterpipe smoking (WPS) on cognitive measures and cardiorespiratory parameters
Objectives: To evaluate the acute effect of one cession of water pipe smoking on:
- executive functions which evaluated by cognitive tests administered included the digit span subtest Wechsler Adult Intelligence Scale (WAIS)-version III hebrew battery, and the Paced Auditory Serial Addition Test (PASAT)
- Cardiorespiratory parameters included vital signs, spirometry parameters and lung clearance index (LCI) value
- serum carboxyhemoglobin, nicotine, and cytokines
Design: Prospective study evaluating these parameters before and after 30 minutes of water pipe smoking (WPS).
Sample size: 55 participants (35 study group, 20 control group) Participant selection: Adults subjects who regularly smoke water pipe. Intervention: Each subject will undergo evaluation including cognitive tests, Cardiorespiratory parameters, carboxy- hemoglobin levels, nicotine levels, serum cytokines levels.
All measurements will be evaluated before and after one cession of 30 minutes water pipe smoking
Study Overview
Status
Conditions
Detailed Description
The effect of repeated testing 30 minutes apart without water pipe smoking (WPS) was evaluated in a group of 20 volunteers (age and sex matched).
Primary outcome parameter: Change in cognitive tests scores Secondary outcome parameter:Change in Cardiorespiratory parameters included vital signs, spirometry parameters and lung clearance index (LCI) value, serum carboxyhemoglobin, nicotine, and cytokines, before and after water pipe smoking
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Haifa, Israel
- Rambam Health Care Campus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy volunteers aged 18 years or older who previously experienced WPS.
Exclusion Criteria:
- pregnant or lactating women
- acute viral or bacterial illness
- oral or intravenous steroid treatment in the previous two weeks
- WPS during the previous 24 hours
- cigarette smoking during the previous 6 hours
- massive exposure to fire smoke during the previous 24 hours.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: study group - Waterpipe Smoking
The Digit span test and Paced Auditory Serial Addition Test (PASAT) performed at baseline and 30minutes after waterpipe smoking. The Digit span test and PASAT with waterpipe smoking |
Cognitive tests at baseline and 30minutes after waterpipe smoking
|
Other: control group
The Digit span test and Paced Auditory Serial Addition Test (PASAT) without waterpipe smoking, performed at 30minures apart. The Digit span test and PASAT without waterpipe smoking |
The Digit span test and Paced Auditory Serial Addition Test (PASAT) at baseline and 30minutes later
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary outcome parameters were executive cognitive measures - The digit span test and Paced Auditory Serial Addition Test (PASAT)
Time Frame: Change from baseline immediately after 30 minutes of smoking
|
The digit span subtest Wechsler Adult Intelligence Scale (WAIS) version III hebrew battery. Participants hear digit sequences of increasing lengths and have to recall them forward and in reversed order. Each level contains two equal number series with different numbers. Higher values represent a better outcome. Maximus score is 30 points. Paced Auditory Serial Addition Test (PASAT) - Single digits are presented every 3 seconds and the participant must add each new digit to the one immediately prior to it. The score is the total number correct out of 60 possible answers. Higher values represent a better outcome. Maximus score is 60 points. |
Change from baseline immediately after 30 minutes of smoking
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate
Time Frame: Baseline and immediately after 30 minutes of smoking
|
Physiological parameter
|
Baseline and immediately after 30 minutes of smoking
|
Respiratory rate
Time Frame: Baseline and immediately after 30 minutes of smoking
|
Physiological parameter
|
Baseline and immediately after 30 minutes of smoking
|
Blood pressure - systolic and diastolic
Time Frame: Baseline and immediately after 30 minutes of smoking
|
Physiological parameter
|
Baseline and immediately after 30 minutes of smoking
|
Oxygen saturation
Time Frame: Baseline and immediately after 30 minutes of smoking
|
Physiological parameter
|
Baseline and immediately after 30 minutes of smoking
|
Pulmonary parameters - Lung clearance index (LCI)
Time Frame: Baseline and immediately after 30 minutes of smoking
|
LCI [multiple breath washouts (MBW)] measurements were performed using the Easy-One Pro, MBW Module (NDD Medical Technologies).
The system consists of a side stream ultrasonic transducer for temperature- and humidity-independent sampling of the molar mass (MMss), a mainstream ultrasonic transducer for flow sampling, and a side stream infrared CO2 analyzer (DUET ETCO2 Module, Welch Allyn OEM Technologies, Beaverton OR) to correct the MMss signal for exhaled CO2.
LCI was calculated as the cumulative expired volume during the washout phase divided by the functional residual capacity (FRC), which is the number of FRC turnovers required to washout the nitrogen.
An increased LCI indicated more FRC turnovers required for the washout, reflecting ventilation inhomogeneity.
At least three technical acceptable MBW tests were required for inclusion of the participants in the final analysis.
|
Baseline and immediately after 30 minutes of smoking
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Pulmonary parameters - spirometry parameters
Time Frame: Baseline and immediately after 30 minutes of smoking
|
spirometry parameters - Spirometry was performed in accordance with the American Thoracic Society/European Respiratory Society Task Force, using a KoKo spirometer (nSpire Health, Inc.; Louisville, Colorado).
Each maneuver was repeated for at least three technically acceptable forced expiratory flow volume curves; the best results were used for analysis
|
Baseline and immediately after 30 minutes of smoking
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Carboxyhemoglobin
Time Frame: Baseline and immediately after 30 minutes of smoking
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Carboxyhemoglobin levels were measured in venous blood samples using an Illex co-oximeter (IL-682; Instrument Laboratory; Lexington, Massachusetts)
|
Baseline and immediately after 30 minutes of smoking
|
Serum nicotine
Time Frame: Baseline and immediately after 30 minutes of smoking
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Serum nicotine concentrations were determined by liquid chromatography-tandem mass spectrometry, with a limit of detection (LOD) of 1ng/mL, lower limit of quantitation (LLOQ) 2ng/mL, and upper limit of quantitation (ULOQ) of 5ng/mL (Quattro micro API equipped with Waters 2795 HPLC; Waters Corp)
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Baseline and immediately after 30 minutes of smoking
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Serum cytokines
Time Frame: Baseline and immediately after 30 minutes of smoking
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The serum cytokines interleukin (IL) 2, IL-5, IL-6, IL-10, tumor necrosis factor alpha (TNFα) and transforming growth factor beta (TGF-β) were measured and analyzed using Human Inflammatory Cytokines Multi-Analyte ELISArray™ Kit [Qiagen, kit# 336161, Hilden, Germany].
The units are (pg/ml).
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Baseline and immediately after 30 minutes of smoking
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lea Bentur, Prof., Rambam Health Care Campus
Publications and helpful links
General Publications
- Hakim F, Hellou E, Goldbart A, Katz R, Bentur Y, Bentur L. The acute effects of water-pipe smoking on the cardiorespiratory system. Chest. 2011 Apr;139(4):775-781. doi: 10.1378/chest.10-1833. Epub 2010 Oct 28.
- Jacob P 3rd, Abu Raddaha AH, Dempsey D, Havel C, Peng M, Yu L, Benowitz NL. Nicotine, carbon monoxide, and carcinogen exposure after a single use of a water pipe. Cancer Epidemiol Biomarkers Prev. 2011 Nov;20(11):2345-53. doi: 10.1158/1055-9965.EPI-11-0545. Epub 2011 Sep 9.
- Roderique JD, Josef CS, Feldman MJ, Spiess BD. A modern literature review of carbon monoxide poisoning theories, therapies, and potential targets for therapy advancement. Toxicology. 2015 Aug 6;334:45-58. doi: 10.1016/j.tox.2015.05.004. Epub 2015 May 18.
- Jasper BW, Hopkins RO, Duker HV, Weaver LK. Affective outcome following carbon monoxide poisoning: a prospective longitudinal study. Cogn Behav Neurol. 2005 Jun;18(2):127-34. doi: 10.1097/01.wnn.0000160820.07836.cf.
- Shihadeh A, Schubert J, Klaiany J, El Sabban M, Luch A, Saliba NA. Toxicant content, physical properties and biological activity of waterpipe tobacco smoke and its tobacco-free alternatives. Tob Control. 2015 Mar;24 Suppl 1(Suppl 1):i22-i30. doi: 10.1136/tobaccocontrol-2014-051907. Epub 2015 Feb 9.
- Bentur L, Hellou E, Goldbart A, Pillar G, Monovich E, Salameh M, Scherb I, Bentur Y. Laboratory and clinical acute effects of active and passive indoor group water-pipe (narghile) smoking. Chest. 2014 Apr;145(4):803-809. doi: 10.1378/chest.13-0960.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0138-16-RMB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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