Acute Effects of Waterpipe Smoking on Cognitive Measures and Cardiorespiratory Parameters
NCT ID: NCT03625440
Last Updated: 2018-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
55 participants
INTERVENTIONAL
2016-08-31
2017-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Objectives: To evaluate the acute effect of one cession of water pipe smoking on:
1. 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)
2. Cardiorespiratory parameters included vital signs, spirometry parameters and lung clearance index (LCI) value
3. 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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Self-Care of Hypertension Among Older Adults During COVID-19
NCT04992000
Stepped Intervention for Meds Adherence and Blood Pressure Control
NCT00257101
Effectiveness of BP Remote Monitoring With Virtual Physician Management in Hypertensive Patients.
NCT05319418
The Effect of Frequent Self Measurements of Blood Pressure on the Control of Hypertension
NCT00459017
The Effect of Self-Titration and Predictors for Blood Pressure Control in Patients With Hypertension
NCT03470974
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
The Digit span test and PASAT with waterpipe smoking
Cognitive tests at baseline and 30minutes after waterpipe smoking
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 PASAT without waterpipe smoking
The Digit span test and Paced Auditory Serial Addition Test (PASAT) at baseline and 30minutes later
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
The Digit span test and PASAT with waterpipe smoking
Cognitive tests at baseline and 30minutes after waterpipe smoking
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rambam Health Care Campus
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lea Bentur, Prof.
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rambam health care campus
Haifa, , Israel
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0138-16-RMB
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.