使用家用智能手表记录数据检测瘦肉精诱导的心率变化:卡塔尔世界杯8强波胆分析随机对照试验%A Elzinga,Willem O %A Prins,Samantha %A Borghans,Laura G J M %A Gal,Pim %A Vargas,Gabriel A A Groeneveld,Geert J %A Doll,Robert人类药物研究中心，Zernikedreef 8，莱顿，2333CL，荷兰，31 715246400，rjdoll@chdr.nl %K光电容积描记术%K智能手表%K可穿戴式%K家用%K心率%K RCT %K可穿戴式设备%K数字健康%K心血管%K心脏病学%K传感器%K心率传感器%K智能科技%D 2021 %7 30.12.2021 %9原始论文%J JMIR表单Res %G英文%X虽然心电图是临床试验中记录心率(HR)的金标准，但基于智能手表的HR监测器的日益普及为药物开发研究提供了可能性。智能手表可以在日常生活中进行廉价、不引人注目和持续的HR估计，以潜在地检测临床外的治疗效果。目的:本研究的目的是评估随机临床试验中收集的基于智能手表的心率估计值的可重复性和敏感性。方法:数据收集为12例帕金森病患者的多剂量、研究者盲法、随机、安慰剂对照、平行组研究的一部分。在6天的基线期后，4名和8名患者分别接受了7天递增剂量的安慰剂和克伦特罗治疗。在整个研究过程中，智能手表提供了人力资源和睡眠状态估计。HR估计值被量化为清醒段和睡眠段中的2.5、50和97.5个百分位。 Linear mixed models were used to calculate the following: (1) the intraclass correlation coefficient (ICC) of estimated sleep durations, (2) the ICC and minimum detectable effect (MDE) of the HR estimates, and (3) the effect sizes of the HR estimates. Results: Sleep duration was moderately repeatable (ICC=0.64) and was not significantly affected by study day (P=.83), clenbuterol (P=.43), and study day by clenbuterol (P=.73). Clenbuterol-induced changes were detected in the asleep HR as of the first night (+3.79 beats per minute [bpm], P=.04) and in the awake HR as of the third day (+8.79 bpm, P=.001). The median HR while asleep had the highest repeatability (ICC=0.70). The MDE (N=12) was found to be smaller when patients were asleep (6.8 bpm to 11.7 bpm) than while awake (10.7 bpm to 22.1 bpm). Overall, the effect sizes for clenbuterol-induced changes were higher while asleep (0.49 to 2.75) than while awake (0.08 to 1.94). Conclusions: We demonstrated the feasibility of using smartwatch-based HR estimates to detect clenbuterol-induced changes during clinical trials. The asleep HR estimates were most repeatable and sensitive to treatment effects. We conclude that smartwatch-based HR estimates obtained during daily living in a clinical trial can be used to detect and track treatment effects. Trial Registration: Netherlands Trials Register NL8002; https://www.trialregister.nl/trial/8002 %M 34967757 %R 10.2196/31890 %U https://formative.www.mybigtv.com/2021/12/e31890 %U https://doi.org/10.2196/31890 %U http://www.ncbi.nlm.nih.gov/pubmed/34967757