Acute Effects of Waterpipe Smoking on Cognitive Measures and Cardiorespiratory Parameters
- Conditions
- Waterpipe Smoking
- Interventions
- Diagnostic Test: The Digit span test and PASAT with waterpipe smokingDiagnostic Test: The Digit span test and PASAT without waterpipe smoking
- Registration Number
- NCT03625440
- Lead Sponsor
- Rambam Health Care Campus
- 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. 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
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
- Healthy volunteers aged 18 years or older who previously experienced WPS.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description study group - Waterpipe Smoking The Digit span test and PASAT with waterpipe smoking 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 control group The Digit span test and PASAT without waterpipe smoking 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
- Primary Outcome Measures
Name Time Method Primary outcome parameters were executive cognitive measures - The digit span test and Paced Auditory Serial Addition Test (PASAT) 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 Outcome Measures
Name Time Method Carboxyhemoglobin 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)
Pulmonary parameters - spirometry parameters 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
Respiratory rate Baseline and immediately after 30 minutes of smoking Physiological parameter
Serum cytokines 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).
Heart rate Baseline and immediately after 30 minutes of smoking Physiological parameter
Blood pressure - systolic and diastolic Baseline and immediately after 30 minutes of smoking Physiological parameter
Oxygen saturation Baseline and immediately after 30 minutes of smoking Physiological parameter
Pulmonary parameters - Lung clearance index (LCI) 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.
Serum nicotine 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)
Trial Locations
- Locations (1)
Rambam health care campus
🇮🇱Haifa, Israel