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Acute Effects of Waterpipe Smoking on Cognitive Measures and Cardiorespiratory Parameters

Acute Effects of Waterpipe Smoking on Cognitive Measures and Cardiorespiratory Parameters

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03625440
Enrollment
55
Registered
2018-08-10
Start date
2016-08-31
Completion date
2017-04-30
Last updated
2018-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Waterpipe Smoking

Keywords

cognitive tests, carboxyhemoglobin, nicotine

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

Interventions

DIAGNOSTIC_TESTThe Digit span test and PASAT with waterpipe smoking

Cognitive tests at baseline and 30minutes after waterpipe smoking

DIAGNOSTIC_TESTThe Digit span test and PASAT without waterpipe smoking

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

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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 smokingThe 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

MeasureTime frameDescription
Respiratory rateBaseline and immediately after 30 minutes of smokingPhysiological parameter
Blood pressure - systolic and diastolicBaseline and immediately after 30 minutes of smokingPhysiological parameter
Oxygen saturationBaseline and immediately after 30 minutes of smokingPhysiological parameter
Pulmonary parameters - Lung clearance index (LCI)Baseline and immediately after 30 minutes of smokingLCI \[multiple breath washouts (MBW)\] 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.
Heart rateBaseline and immediately after 30 minutes of smokingPhysiological parameter
CarboxyhemoglobinBaseline and immediately after 30 minutes of smokingCarboxyhemoglobin levels were measured in venous blood samples using an Illex co-oximeter (IL-682; Instrument Laboratory; Lexington, Massachusetts)
Serum nicotineBaseline and immediately after 30 minutes of smokingSerum 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)
Serum cytokinesBaseline and immediately after 30 minutes of smokingThe 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).
Pulmonary parameters - spirometry parametersBaseline and immediately after 30 minutes of smokingspirometry 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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026