Anderson Daniel J, Troxel Wendy M, Landvatter Joshua, Baron Kelly Glazer
Department of Family and Preventive Medicine, University of Utah, Salt Lake City, Utah.
Division of Social and Economic Wellbeing, Rand Corporation, Pittsburgh, Pennsylvania.
J Clin Sleep Med. 2025 Jul 1;21(7):1285-1291. doi: 10.5664/jcsm.11690.
Poor sleep quality is a global public health issue. Technology approaches are desirable to patients and offer a potentially scalable solution to improve sleep health. The goal of this study was to test the effects of a novel wearable device for improving sleep.
Participants with elevated scores on the Insomnia Severity Index (≥ 15) were recruited from social media advertisements and a university research study website. Eligible participants completed a baseline survey, wore a Fitbit, and completed sleep diaries for 1 week. Participants were randomly assigned to either an active or sham program (ie, same device but using nontherapeutic frequencies). Participants were asked to wear the device for at least 3 hours per day for 4 weeks. Devices were turned to active from 4 weeks until the final questionnaire assessment at 3 months. The primary outcome at 4 weeks was change in self-reported insomnia symptoms. Self-reported outcomes were also assessed at 3 months.
Participants in both the intervention and control groups experienced significant improvements in most self-reported sleep and daytime function measures. The intervention group reported greater improvement in diary-sleep efficiency. There was no significant change in Fitbit-assessed sleep.
Results demonstrate high interest in the intervention and feasibility of the wearable device, but improvements in sleep and daytime function were observed in participants using the active and placebo devices.
Registry: ClinicalTrials.gov; Name: A Novel Wearable Device for the Treatment of Insomnia; URL: https://clinicaltrials.gov/study/NCT05952297; Identifier: NCT05952297.
Anderson DJ, Troxel WM, Landvatter J, Baron KG. A randomized pilot study of a wearable device using variable complex weak magnetic fields among participants with insomnia symptoms. . 2025;21(7):1285-1291.
睡眠质量差是一个全球性的公共卫生问题。技术手段受到患者青睐，并为改善睡眠健康提供了一种潜在的可扩展解决方案。本研究的目的是测试一种新型可穿戴设备对改善睡眠的效果。
从社交媒体广告和大学研究网站招募失眠严重程度指数得分较高（≥15）的参与者。符合条件的参与者完成基线调查，佩戴Fitbit，并记录1周的睡眠日记。参与者被随机分配到主动治疗组或假治疗组（即使用相同设备，但采用非治疗频率）。要求参与者每天佩戴该设备至少3小时，持续4周。从第4周开始将设备设置为主动治疗模式，直至3个月时进行最终问卷调查评估。4周时的主要结局是自我报告的失眠症状变化。在3个月时也评估了自我报告的结局。
干预组和对照组的大多数自我报告的睡眠和日间功能指标均有显著改善。干预组报告在日记记录的睡眠效率方面有更大改善。Fitbit评估的睡眠没有显著变化。
结果表明参与者对该干预措施高度关注，且该可穿戴设备具有可行性，但使用主动治疗设备和安慰剂设备的参与者在睡眠和日间功能方面均有改善。
注册机构：ClinicalTrials.gov；名称：一种用于治疗失眠的新型可穿戴设备；网址：https://clinicaltrials.gov/study/NCT05952297；标识符：NCT05952297。
Anderson DJ, Troxel WM, Landvatter J, Baron KG. 一项针对有失眠症状参与者使用可变复合弱磁场的可穿戴设备的随机试点研究。. 2025;21(7):1285 - 1291。
