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Completed

NCT Number: NCT03625440

Acute Effects of Waterpipe Smoking on Cognitive Measures and Cardiorespiratory Parameters

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

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Key information

Conditions

Waterpipe Smoking Behavior Pipe Smoking Smoking Water Pipe Smoking

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam health care campus

Haifa, Israel

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Digit span test and PASAT with waterpipe smoking

Diagnostic Test

Cognitive tests at baseline and 30minutes after waterpipe smoking

The Digit span test and PASAT without waterpipe smoking

Diagnostic Test

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

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Heart rate

    Time frame: Baseline and immediately after 30 minutes of smoking

    Physiological parameter

  2. Respiratory rate

    Time frame: Baseline and immediately after 30 minutes of smoking

    Physiological parameter

  3. Blood pressure - systolic and diastolic

    Time frame: Baseline and immediately after 30 minutes of smoking

    Physiological parameter

  4. Oxygen saturation

    Time frame: Baseline and immediately after 30 minutes of smoking

    Physiological parameter

  5. Pulmonary parameters - Lung clearance index (LCI)

    Time frame: Baseline and immediately after 30 minutes of smoking

    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.

  6. Pulmonary parameters - spirometry parameters

    Time frame: Baseline and immediately after 30 minutes of smoking

    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

  7. Carboxyhemoglobin

    Time frame: Baseline and immediately after 30 minutes of smoking

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

  8. Serum nicotine

    Time frame: Baseline and immediately after 30 minutes of smoking

    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)

  9. Serum cytokines

    Time frame: Baseline and immediately after 30 minutes of smoking

    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).

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 10, 2018
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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