NCT03625440

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. 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. 2.Cardiorespiratory parameters included vital signs, spirometry parameters and lung clearance index (LCI) value
  3. 3.serum carboxyhemoglobin, nicotine, and cytokines

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

May 29, 2018

Last Update Submit

August 9, 2018

Conditions

Waterpipe Smoking

Keywords

cognitive testscarboxyhemoglobinnicotine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Heart rate

    Baseline and immediately after 30 minutes of smoking

  • Respiratory rate

    Baseline and immediately after 30 minutes of smoking

  • Blood pressure - systolic and diastolic

    Baseline and immediately after 30 minutes of smoking

  • Oxygen saturation

    Baseline and immediately after 30 minutes of smoking

  • Pulmonary parameters - Lung clearance index (LCI)

    Baseline and immediately after 30 minutes of smoking

  • +4 more secondary outcomes

Study Arms (2)

study group - Waterpipe Smoking

OTHER

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

Diagnostic Test: The Digit span test and PASAT with waterpipe smoking

control group

OTHER

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

Diagnostic Test: The Digit span test and PASAT without waterpipe smoking

Interventions

The Digit span test and PASAT with waterpipe smokingDIAGNOSTIC_TEST

Cognitive tests at baseline and 30minutes after waterpipe smoking

study group - Waterpipe Smoking
The Digit span test and PASAT without waterpipe smokingDIAGNOSTIC_TEST

The Digit span test and Paced Auditory Serial Addition Test (PASAT) at baseline and 30minutes later

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers aged 18 years or older who previously experienced WPS.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

Related Publications (6)

  • 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.

    PMID: 21030492RESULT

  • 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.

    PMID: 21908725RESULT

  • 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.

    PMID: 25997893RESULT

  • 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.

    PMID: 15970733RESULT

  • 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.

    PMID: 25666550RESULT

  • 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.

    PMID: 24158379RESULT

MeSH Terms

Conditions

Water Pipe Smoking

Condition Hierarchy (Ancestors)

Pipe SmokingSmokingBehavior

Study Officials

  • Lea Bentur, Prof.

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2018

First Posted

August 10, 2018

Study Start

August 1, 2016

Primary Completion

March 1, 2017

Study Completion

April 1, 2017

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

IL(1)