Acute Effects of Waterpipe Smoking on Cognitive Measures and Cardiorespiratory Parameters

Waterpipe Smoking Clinical Trial

Official title:

Acute Effects of Waterpipe Smoking on Cognitive Measures and Cardiorespiratory Parameters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03625440
• Other study ID #: 0138-16-RMB
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: April 2017

Study information

• Verified date: August 2018
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Waterpipe Smoking

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

References & Publications (6)

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. — View 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. — View 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-11-054 — View 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. — View 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. — View 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:i22-i30. doi: 10.1136/tobaccoco — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome parameters were executive cognitive measures - The digit span test and Paced Auditory Serial Addition Test (PASAT)	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	Heart rate	Physiological parameter	Baseline and immediately after 30 minutes of smoking
Secondary	Respiratory rate	Physiological parameter	Baseline and immediately after 30 minutes of smoking
Secondary	Blood pressure - systolic and diastolic	Physiological parameter	Baseline and immediately after 30 minutes of smoking
Secondary	Oxygen saturation	Physiological parameter	Baseline and immediately after 30 minutes of smoking
Secondary	Pulmonary parameters - Lung clearance index (LCI)	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
Secondary	Pulmonary parameters - spirometry parameters	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
Secondary	Carboxyhemoglobin	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
Secondary	Serum nicotine	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)	Baseline and immediately after 30 minutes of smoking
Secondary	Serum cytokines	The serum cytokines interleukin (IL) 2, IL-5, IL-6, IL-10, tumor necrosis factor alpha (TNFa) and transforming growth factor beta (TGF-ß) were measured and analyzed using Human Inflammatory Cytokines Multi-Analyte ELISArray™ Kit [Qiagen, kit# 336161, Hilden, Germany]. The units are (pg/ml).	Baseline and immediately after 30 minutes of smoking