A randomized pilot study of a wearable device using variable complex weak magnetic fields among participants with insomnia symptoms.

STUDY OBJECTIVES

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

CLINICAL TRIAL REGISTRATION

Registry: ClinicalTrials.gov; Name: A Novel Wearable Device for the Treatment of Insomnia; URL: https://clinicaltrials.gov/study/NCT05952297; Identifier: NCT05952297.

CITATION

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.