跳至主要内容
临床试验/NCT03625440
NCT03625440已完成不适用

Acute Effects of Waterpipe Smoking on Cognitive Measures and Cardiorespiratory Parameters

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2016年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
1
主要终点
Primary outcome parameters were executive cognitive measures - The digit span test and Paced Auditory Serial Addition Test (PASAT)

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

study group - Waterpipe Smoking

Other

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

干预措施: The Digit span test and PASAT with waterpipe smoking (Diagnostic Test)

control group

Other

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

干预措施: The Digit span test and PASAT without waterpipe smoking (Diagnostic Test)

结局指标

主要结局

Primary outcome parameters were executive cognitive measures - The digit span test and Paced Auditory Serial Addition Test (PASAT)

时间窗: 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.

次要结局

  • Carboxyhemoglobin(Baseline and immediately after 30 minutes of smoking)
  • Pulmonary parameters - spirometry parameters(Baseline and immediately after 30 minutes of smoking)
  • Respiratory rate(Baseline and immediately after 30 minutes of smoking)
  • Serum cytokines(Baseline and immediately after 30 minutes of smoking)
  • Heart rate(Baseline and immediately after 30 minutes of smoking)
  • Blood pressure - systolic and diastolic(Baseline and immediately after 30 minutes of smoking)
  • Oxygen saturation(Baseline and immediately after 30 minutes of smoking)
  • Pulmonary parameters - Lung clearance index (LCI)(Baseline and immediately after 30 minutes of smoking)
  • Serum nicotine(Baseline and immediately after 30 minutes of smoking)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验