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Waterpipe SmokingNCT03625440

Acute Effects of Waterpipe Smoking on Cognitive Measures and Cardiorespiratory Parameters

A study testing The Digit span test and PASAT with waterpipe smoking and The Digit span test and PASAT without waterpipe smoking in people with Waterpipe Smoking, run by Rambam Health Care Campus at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Waterpipe Smoking
What is being tested?
The Digit span test and PASAT with waterpipe smoking and The Digit span test and PASAT without waterpipe smoking
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteIsrael
Study dates
Aug 2016to Apr 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Rambam health care campus

    Haifa

Other trials in Israel

About this study

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:

Read more
  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

Read the 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

Being tested
The Digit span test and PASAT with waterpipe smoking, The Digit span test and PASAT without waterpipe smoking
Keywords
cognitive tests, carboxyhemoglobin, nicotine
Medical subject headings
Water Pipe Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Digit span test and PASAT with waterpipe smokingDiagnostic test

    Cognitive tests at baseline and 30minutes after 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

Study groups in NCT03625440
Study groupRoleWhat they receive
study group - Waterpipe SmokingOtherThe 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
Receives: Diagnostic Test: The Digit span test and PASAT with waterpipe smoking
control groupOtherThe 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
Receives: Diagnostic Test: The Digit span test and PASAT without waterpipe smoking

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Change from baseline immediately after 30 minutes of smoking

Secondary outcomes (9)

  1. Heart rate

    Physiological parameter

    Measured: Baseline and immediately after 30 minutes of smoking

  2. Respiratory rate

    Physiological parameter

    Measured: Baseline and immediately after 30 minutes of smoking

  3. Blood pressure - systolic and diastolic

    Physiological parameter

    Measured: Baseline and immediately after 30 minutes of smoking

  4. Oxygen saturation

    Physiological parameter

    Measured: Baseline and immediately after 30 minutes of smoking

  5. 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.

    Measured: Baseline and immediately after 30 minutes of smoking

  6. 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

    Measured: Baseline and immediately after 30 minutes of smoking

  7. Carboxyhemoglobin

    Carboxyhemoglobin levels were measured in venous blood samples using an Illex co-oximeter (IL-682; Instrument Laboratory; Lexington, Massachusetts)

    Measured: Baseline and immediately after 30 minutes of smoking

  8. 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)

    Measured: Baseline and immediately after 30 minutes of smoking

  9. Serum cytokines

    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).

    Measured: Baseline and immediately after 30 minutes of smoking

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2018
  2. Study startAug 2016
  3. Primary completionMar 2017
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03625440
Sponsor's protocol ID
0138-16-RMB
Status last verified
Aug 2018
First submitted
29 May 2018
Last updated
10 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 21030492

  • 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.

    PubMed 21908725

  • 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.

    PubMed 25997893

  • 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.

    PubMed 15970733

  • 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.

    PubMed 25666550

  • 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.

    PubMed 24158379

Questions about this trial

What is this clinical trial studying?

A study testing The Digit span test and PASAT with waterpipe smoking and The Digit span test and PASAT without waterpipe smoking in people with Waterpipe Smoking, run by Rambam Health Care Campus at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03625440, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.

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