此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Puff Topography and Sensory Effects Across IQOS Device Generations

2026年7月29日 更新者：American University of Beirut Medical Center

Puff Topography and Sensory Effects Across IQOS Device Generations: A Randomized Crossover Study

The goal of this clinical trial is to learn how people use two generations of IQOS heated tobacco devices and how each device affects their smoking behavior and sensory experience.

The main questions it aims to answer are:

  • Do participants puff differently when using the newer IQOS Iluma i compared to the older IQOS 2.4?
  • Does the flavor of the tobacco stick (preferred flavor vs. standard tobacco flavor) affect puffing behavior or sensory experience?
  • What are the differences in throat hit, mouthfeel, and satisfaction between the two devices?

Participants will:

  • Attend 2 laboratory visits at the American University of Beirut
  • Use both the IQOS Iluma i and IQOS 2.4 devices during each visit
  • Have their puffing behavior recorded automatically during device use
  • Provide a breath sample before and after each use session
  • Complete short questionnaires about how each device felt and their urge to smoke

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Heated tobacco products (HTPs) such as IQOS have evolved across generations, with newer models using induction-based heating rather than a ceramic blade. Nicotine yields have declined across generations, raising the possibility that sensory characteristics have been modified to maintain product appeal. Current emissions assessments rely on standardized machine-puffing regimens derived from cigarette testing, which may not reflect real-world IQOS user behavior. This study will characterize puff topography (volume, duration, flow rate, inter-puff interval, number of puffs) in 50 exclusive IQOS users during ad-libitum use of the IQOS Iluma i and IQOS 2.4 under preferred and standardized (Amber) flavor conditions. A randomized crossover design with two visits will be used, with device order within each visit randomized using a Williams design. Secondary outcomes include chemosensory ratings (mouthfeel, ease of draw, throat hit), and subjective effects (satisfaction, pleasantness, taste, urges). Data will inform device-specific puffing regimens for use in future emissions assessments.

研究类型

介入性

注册 (估计的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Soha Talih, PhD
  • 电话号码：3627 +961-1-350000
  • 邮箱：st38@aub.edu.lb

研究联系人备份

  • 姓名：Mario El Hourani, PhD
  • 电话号码：+96170715263
  • 邮箱：me217@aub.edu.lb

学习地点

  • 黎巴嫩
      • Beirut、黎巴嫩
        • 招聘中
        • Clinical Aerosol Technology Laboratory (CATLAB), American University of Beirut
    • Beirut
      • Beirut、Beirut、黎巴嫩、1107 2020
        • 招聘中
        • Clinical Aerosol Technology Laboratory (CATLAB), American University of Beirut
        • 接触：
          • Dr. Soha Talih, PHD
          • 电话号码：3627 +9611350000
          • 邮箱：st38@aub.edu.lb

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Current IQOS user (at least 3 days per week in the past 30 days)
  • Age 18 to 65 years
  • Generally healthy
  • Willing to provide informed written consent
  • Willing to attend all laboratory visits
  • Willing to abstain from all nicotine and tobacco products for at least 12 hours before each visit

Exclusion Criteria:

  • Use of any tobacco products other than IQOS in the past 30 days
  • Chronic cardiovascular conditions, seizures, or abnormal blood pressure
  • Current psychiatric disorder requiring active treatment, including major depressive disorder
  • Regular use of prescription medications that may influence cardiovascular function, respiratory function, or nicotine metabolism (excluding vitamins or birth control)
  • Use of cocaine, opioids, benzodiazepines, or methamphetamines in the past month
  • Marijuana use on more than 15 days per month
  • Current pregnancy or breastfeeding
  • Plans to quit nicotine or tobacco products within the next 30 days

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：基础科学
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：IQOS Iluma i (Induction Heating)
Participants use the IQOS Iluma i device with TEREA tobacco sticks under two flavor conditions (preferred flavor and standardized Amber flavor) across study visits. The IQOS Iluma i uses induction-based heating technology.
设备：IQOS Iluma i with TEREA Tobacco Sticks
The IQOS Iluma i is an induction-heated tobacco device used with TEREA STICKS. Participants use the device ad libitum during two smoking bouts (preferred flavor and Amber flavor conditions) across two study visits. Puff topography is recorded continuously during use.
有源比较器：IQOS 2.4 (Blade Heating)
Participants use the IQOS 2.4 device with HEETS tobacco sticks under two flavor conditions (preferred flavor and standardized Amber flavor) across study visits. The IQOS 2.4 uses ceramic blade heating technology.
设备：IQOS 2.4 with HEETS Tobacco Sticks
The IQOS 2.4 is a ceramic blade-heated tobacco device used with HEETS tobacco sticks. Participants use the device ad libitum during two smoking bouts (preferred flavor and Amber flavor conditions) across two study visits. Puff topography is recorded continuously during use.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Chemosensory Effects - Mouthful
大体时间：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Chemosensory Effects: Three sensory feedback items assessed after each smoking bout: (1) Mouthful - amount of aerosol filling the mouth, rated on a 1-5 visual analog scale (1 = barely any smoke to 5 = a lot of smoke); higher scores indicate greater mouthful sensation.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Chemosensory Effects - Ease of draw
大体时间：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Chemosensory Effects: Three sensory feedback items assessed after each smoking bout: (2) Ease of draw - effort required to draw a puff, rated on a 1-5 visual analog scale (1 = easy to 5 = hard); higher scores indicate greater effort required.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Chemosensory Effects - Throat hit
大体时间：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Chemosensory Effects: Three sensory feedback items assessed after each smoking bout: (3) Throat hit - intensity of throat sensation, rated on a 0-100 General Labeled Magnitude Scale (0 = barely detectable to 100 = strongest imaginable); higher scores indicate greater throat hit intensity.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Mean Puff Duration
大体时间：Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Mean duration (seconds) of each puff recorded continuously during ad-libitum use of each device using the eTOP puff topography instrument.
Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Number of Puffs Per Stick
大体时间：Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Total number of puffs taken per tobacco stick during each ad-libitum smoking bout, recorded using the eTOP puff topography instrument.
Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Mean Inter-Puff Interval
大体时间：Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Mean time (seconds) between the end of one puff and the start of the next, recorded continuously during ad-libitum use of each device using the eTOP puff topography instrument.
Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Mean Puff Flow Rate
大体时间：Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Mean peak puff flow rate (mL/s) recorded continuously during ad-libitum use of each device using the eTOP puff topography instrument.
Continuously during each ad-libitum smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Urge to Use IQOS - Factor 1: desire/intention
大体时间：Immediately before and immediately after each smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Urge to use IQOS assessed using a 10-item adaptation of the Questionnaire on Smoking Urges-Brief (QSU-Brief), rated on a 7-point scale (1 = Strongly Disagree to 7 = Strongly Agree). Higher scores indicate greater urge to use IQOS. Total score and subscale scores (Factor 1: desire/intention; Factor 2: negative reinforcement) will be reported.
Immediately before and immediately after each smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Urge to Use IQOS - Factor 2: negative reinforcement
大体时间：Immediately before and immediately after each smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Urge to use IQOS assessed using a 10-item adaptation of the Questionnaire on Smoking Urges-Brief (QSU-Brief), rated on a 7-point scale (1 = Strongly Disagree to 7 = Strongly Agree). Higher scores indicate greater urge to use IQOS. Total score and subscale scores (Factor 1: desire/intention; Factor 2: negative reinforcement) will be reported.
Immediately before and immediately after each smoking bout, at Visit 1 (day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - satisfaction
大体时间：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - taste
大体时间：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - throat/chest sensations
大体时间：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - calm
大体时间：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - awake
大体时间：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - irritable
大体时间：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - concentration
大体时间：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - hungry
大体时间：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - dizziness
大体时间：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - nausea
大体时间：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - craving relief
大体时间：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
Subjective Effects of IQOS Use - enjoyment
大体时间：Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)
12-item questionnaire assessing subjective effects of IQOS use, rated on a 7-point scale (1 = Not at all to 7 = Extremely). Higher scores indicate greater intensity of the effect. Items assess: satisfaction, taste, throat/chest sensations, calming, alertness, irritability relief, concentration, hunger suppression, dizziness, nausea, craving relief, and enjoyment. Each item is reported individually. The questionnaire is a modified version of the Subjective Effects Questionnaire (SEQ), adapted for IQOS.
Immediately after each smoking bout, at Visit 1 (Day 1) and Visit 2 (Visit 2 scheduled at least 48 hours after Visit 1)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

American University of Beirut Medical Center

调查人员

  • 首席研究员：Soha Talih、American University of Beirut Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月27日

初级完成 (估计的)

2027年10月1日

研究完成 (估计的)

2027年12月15日

研究注册日期

首次提交

2026年7月3日

首先提交符合 QC 标准的

2026年7月13日

首次发布 (实际的)

2026年7月20日

研究记录更新

最后更新发布 (实际的)

2026年7月30日

上次提交的符合 QC 标准的更新

2026年7月29日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BIO-2026-0012
  • AUB (其他赠款/资助编号：American University of Beirut)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared. Data are stored on password-protected institutional computers at the American University of Beirut and are accessible only to authorized study personnel. Data may be made available to qualified researchers upon reasonable request to the corresponding author.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅