Clinical trial NCT03625440: Acute Effects of Waterpipe Smoking on Cognitive Measures and Cardiorespiratory Parameters
Official title: Acute Effects of Waterpipe Smoking on Cognitive Measures and Cardiorespiratory Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Waterpipe Smoking
Keywords: cognitive tests
carboxyhemoglobin
nicotine
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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:

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Primary outcome parameters were executive cognitive measures - The digit span test and Paced Auditory Serial Addition Test (PASAT)
timeFrame: Change from baseline immediately after 30 minutes of smoking
Secondary outcomes:
measure: Heart rate
timeFrame: Baseline and immediately after 30 minutes of smoking
measure: Respiratory rate
timeFrame: Baseline and immediately after 30 minutes of smoking
measure: Blood pressure - systolic and diastolic
timeFrame: Baseline and immediately after 30 minutes of smoking
measure: Oxygen saturation
timeFrame: Baseline and immediately after 30 minutes of smoking
measure: Pulmonary parameters - Lung clearance index (LCI)
timeFrame: Baseline and immediately after 30 minutes of smoking
measure: Pulmonary parameters - spirometry parameters
timeFrame: Baseline and immediately after 30 minutes of smoking
measure: Carboxyhemoglobin
timeFrame: Baseline and immediately after 30 minutes of smoking
measure: Serum nicotine
timeFrame: Baseline and immediately after 30 minutes of smoking
measure: Serum cytokines
timeFrame: Baseline and immediately after 30 minutes of smoking
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: Lea Bentur, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.