ABSTRACT

Objective

This pilot trial aimed to provide evidence for whether the integration of a wearable device with digital behavioral therapy for insomnia (dBTi) improves treatment outcomes and engagement.

Participants and Methods

One hundred and twenty-eight participants with insomnia symptoms were randomized to a 3-week dBTi program (SleepFix®) with a wearable device enabling sleep data synchronization (dBTi+wearable group; n = 62) or dBTi alone (n = 66). Participants completed the Insomnia Severity Index (ISI) and modified Pittsburgh Sleep Quality Index (PSQI) parameters: wake-after-sleep-onset (WASO), sleep-onset-latency (SOL), and total sleep time (TST) at baseline and weeks 1, 2, 3, and primary endpoint of week 6 and follow-up at 12 weeks. Engagement was measured by the number of daily sleep diaries logged in the app.

Results

There was no difference in ISI change scores between the groups from pre- to post-treatment (Cohen’s d= 0.7, p= .061). The dBTi+wearable group showed greater improvements in WASO (d= 0.8, p = .005) and TST (d= 0.3, p= .049) compared to the dBTi group. Significantly greater engagement (sleep diary entries) was observed in the dBTi+wearable group (mean = 22.4, SD = 10.0) compared to the dBTi group (mean = 14.1, SD = 14.2) (p = .010).

Conclusions

This pilot trial found that integration of wearable device with a digital insomnia therapy enhanced user engagement and led to improvements in sleep parameters compared to dBTi alone. These findings suggest that adjunctive wearable technologies may improve digital insomnia therapy effectiveness.

中文翻译：

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辅助可穿戴技术治疗数字失眠症的有效性：一项试点随机对照试验

摘要

客观的

该试点试验旨在为可穿戴设备与失眠症数字行为疗法 (dBTi) 的整合是否能改善治疗效果和参与度提供证据。

参与者和方法

128 名有失眠症状的参与者被随机分配到一个为期 3 周的 dBTi 计划 (SleepFix®)，该计划使用可实现睡眠数据同步的可穿戴设备（dBTi+可穿戴组；n = 62）或单独的 dBTi（n = 66）。参与者完成了失眠严重度指数 (ISI) 和修正的匹兹堡睡眠质量指数 (PSQI) 参数：入睡后醒来 (WASO)、入睡潜伏期 (SOL) 和总睡眠时间 (TST) 在基线和第 1、2、3 周和第 6 周的主要终点和第 12 周的随访。参与度是通过在应用程序中记录的每日睡眠日记的数量来衡量的。

结果

从治疗前到治疗后，各组之间的 ISI 变化评分没有差异（Cohen's d = 0.7，p = .061）。与 dBTi 组相比，dBTi+可穿戴组在 WASO ( d = 0.8, p = .005) 和 TST ( d = 0.3, p = .049) 方面表现出更大的改善。与 dBTi 组（平均值 = 14.1，SD = 14.2）相比，在 dBTi+可穿戴组（平均值 = 22.4，SD = 10.0）中观察到显着更高的参与度（睡眠日记条目）（p = .010）。

结论

该试点试验发现，与单独使用 dBTi 相比，可穿戴设备与数字失眠疗法的集成增强了用户参与度，并改善了睡眠参数。这些发现表明，辅助可穿戴技术可以提高数字失眠治疗的有效性。