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使用非侵入性可穿戴生物监测来检测吸烟前、吸烟和戒烟后阶段:一项观察性实验室研究方案

Use of non-invasive wearables biomonitoring to detect presmoking, smoking and postsmoking stages: protocol for an observational laboratory study.

作者信息

El-Toukhy Sherine, Haghayegh Shahab, Leavens Eleanor, Sassano Flori, Tarran Robert

机构信息

Division of Intramural Research, National Institute on Minority Health and Health Disparities, National Institutes of Health, Rockville, Maryland, USA

Harvard Medical School, Boston, Massachusetts, USA.

出版信息

BMJ Open. 2025 Aug 16;15(8):e103292. doi: 10.1136/bmjopen-2025-103292.

Abstract

INTRODUCTION

Reliable detection of cigarette smoking is necessary for just-in-time adaptive smoking cessation support. Smoking detection typically relies on intervention recipients to self-report smoking behaviours and their antecedents, which is burdensome and subject to reporting biases, or on specialised sensors and wearables to detect smoking gestures, which may not be feasible for real-world implementation. Here, we describe an observational laboratory-based study protocol designed to identify signature biomarkers and hand-mouth gestures associated with presmoking, smoking and postsmoking using off-the-shelf wearable devices.

METHODS AND ANALYSIS

30 non-treatment seeking individuals who use combustible tobacco products will participate in the study. Participants will be monitored for 1 hour in a smoking chamber, during which time they will wear a Garmin device that will collect hand/arm movement, heart rate, heart rate variability, blood oxygenation and respiratory rate. First, participants will be in a nicotine-deprived state based on 12-hour abstinence validated by exhaled carbon monoxide readings (20 min). Then, participants will be allowed to smoke cigarettes of their choice (10-15 min). Finally, participants will be in a nicotine-satiated state (~25 min). Participants will be video recorded to allow us to label the data corresponding to the smoking stage and behaviour. We will conduct time-series analysis and analysis of variance to quantify changes in biomarkers between smoking stages.

ETHICS AND DISSEMINATION

The Institutional Review Board of the University of Kansas Medical Centre approved the study on 21/3/2025 (STUDY00161139). Participants will provide informed consent to participate in the study. Data collection is expected to begin in September 2025 and results will be submitted for publication in 2026.

TRIAL REGISTRATION NUMBER

NCT07067151.

摘要

引言

可靠地检测吸烟情况对于及时提供适应性戒烟支持至关重要。吸烟检测通常依赖于干预对象自我报告吸烟行为及其相关因素,这既繁琐又容易出现报告偏差,或者依赖专门的传感器和可穿戴设备来检测吸烟动作,但这在实际应用中可能并不可行。在此,我们描述一项基于观察性实验室的研究方案,旨在使用现成的可穿戴设备识别与吸烟前、吸烟中和吸烟后相关的标志性生物标志物和手口动作。

方法与分析

30名使用可燃烟草制品且未寻求治疗的个体将参与该研究。参与者将在吸烟室内接受1小时的监测,在此期间他们将佩戴佳明设备,该设备将收集手部/手臂运动、心率、心率变异性、血液氧合和呼吸频率。首先,根据通过呼出一氧化碳读数验证的12小时禁欲情况(约20分钟),使参与者处于尼古丁剥夺状态。然后,允许参与者吸他们选择的香烟(约10 - 15分钟)。最后,参与者将处于尼古丁饱和状态(约25分钟)。将对参与者进行视频记录,以便我们标记与吸烟阶段和行为相对应的数据。我们将进行时间序列分析和方差分析,以量化吸烟阶段之间生物标志物的变化。

伦理与传播

堪萨斯大学医学中心机构审查委员会于2025年3月21日批准了该研究(研究编号:STUDY00161139)。参与者将提供知情同意书以参与该研究。数据收集预计于2025年9月开始,结果将于2026年提交发表。

试验注册号

NCT07067151。

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