Acute Effects of Waterpipe Smoking on Cognitive Measures and Cardiorespiratory Parameters

Study Overview
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Brief Summary
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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: 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) Cardiorespiratory parameters included vital signs, spirometry parameters and lung clearance index (LCI) value 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
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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

Official Title
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Acute Effects of Waterpipe Smoking on Cognitive Measures and Cardiorespiratory Parameters

Conditions
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Waterpipe Smoking

Intervention / Treatment
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* Diagnostic Test: The Digit span test and PASAT with waterpipe smoking
* Diagnostic Test: The Digit span test and PASAT without waterpipe smoking


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: study group - Waterpipe Smoking<br>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<br>* Cognitive tests at baseline and 30minutes after waterpipe smoking<br>|
| Other: control group<br>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<br>* The Digit span test and Paced Auditory Serial Addition Test (PASAT) at baseline and 30minutes later<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Physiological parameter | Baseline and immediately after 30 minutes of smoking | 
| Respiratory rate | Physiological parameter | Baseline and immediately after 30 minutes of smoking | 
| Blood pressure - systolic and diastolic | Physiological parameter | Baseline and immediately after 30 minutes of smoking | 
| Oxygen saturation | Physiological parameter | Baseline and immediately after 30 minutes of smoking | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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). | Baseline and immediately after 30 minutes of smoking | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive tests, carboxyhemoglobin, nicotine