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可穿戴剂量计和光记录器的验证、分析验证及临床验证(V3)

Verification, analytical validation and clinical validation (V3) of wearable dosimeters and light loggers.

作者信息

Spitschan Manuel, Smolders Karin, Vandendriessche Benjamin, Bent Brinnae, Bakker Jessie P, Rodriguez-Chavez Isaac R, Vetter Céline

机构信息

Translational Sensory & Circadian Neuroscience, Max Planck Institute for Biological Cybernetics, Tübingen, Germany.

Chronobiology & Health, TUM Department of Sport and Health Sciences (TUM SG), Technical University of Munich, Munich, Germany.

出版信息

Digit Health. 2022 Dec 25;8:20552076221144858. doi: 10.1177/20552076221144858. eCollection 2022 Jan-Dec.

Abstract

BACKGROUND

Light exposure is an important driver and modulator of human physiology, behavior and overall health, including the biological clock, sleep-wake cycles, mood and alertness. Light can also be used as a directed intervention, e.g., in the form of light therapy in seasonal affective disorder (SAD), jetlag prevention and treatment, or to treat circadian disorders. Recently, a system of quantities and units related to the physiological effects of light was standardized by the International Commission on Illumination (CIE S 026/E:2018). At the same time, biometric monitoring technologies (BioMeTs) to capture personalized light exposure were developed. However, because there are currently no standard approaches to evaluate the digital dosimeters, the need to provide a firm framework for the characterization, calibration, and reporting for these digital sensors is urgent.

OBJECTIVE

This article provides such a framework by applying the principles of , and (V3) as a state-of-the-art approach for tools and standards in digital medicine to light dosimetry.

RESULTS

This article describes opportunities for the use of digital dosimeters for basic research, for monitoring light exposure, and for measuring adherence in both clinical and non-clinical populations to light-based interventions in clinical trials.

摘要

背景

光照是人类生理、行为和整体健康的重要驱动因素和调节因素,包括生物钟、睡眠-觉醒周期、情绪和警觉性。光还可以用作一种定向干预手段,例如以光疗法的形式用于季节性情感障碍(SAD)、预防和治疗时差反应,或治疗昼夜节律紊乱。最近,国际照明委员会(CIE S 026/E:2018)对与光的生理效应相关的量和单位系统进行了标准化。与此同时,开发了用于捕捉个性化光照的生物特征监测技术(BioMeTs)。然而,由于目前没有评估数字剂量计的标准方法,迫切需要为这些数字传感器的特性描述、校准和报告提供一个坚实的框架。

目的

本文通过应用、和(V3)的原则,为数字医学中的工具和标准提供一种最新方法,从而为光剂量测定提供这样一个框架。

结果

本文描述了在基础研究中使用数字剂量计、监测光照以及测量临床和非临床人群在临床试验中对基于光的干预措施的依从性的机会。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3c6/9806438/ccfd2ceeb7e2/10.1177_20552076221144858-fig1.jpg

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