A Novel Wearable Device to Improve Sleep Quality

NCT05952297 | Completed Phase 2 Results

• 1 other identifier: 00165943
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to help determine if a wearable sleep wellness device improves sleep among adults with insomnia. This study will enroll a total of 60 participants for this remotly conducted study and randomize 1:1 for treatment and control. Aim 1 of the study is to test the effects of the sleep wellness device compared to a placebo device on sleep after 28 days of use. Aim 2 of the study is to test the longer term effects of the sleep wellness device at 3 month follow-up.

Conditions

Insomnia

Keywords

insomnia; sleep

Outcome Measures

Primary Outcomes (1)

• Insomnia Symptoms

  The insomnia severity index (ISI) is a self-report item of insomnia symptoms that is well correlated with insomnia diagnoses, with higher scores being worse insomnia. Scores range from 0-28.

  Change from baseline in insomnia symptoms at 28 days

Study Arms (2)

Sleep Wellness Device

EXPERIMENTAL

The wearable sleep wellness device that contains specially designed coils that generate micro electromagnetic stimulation located in the neckband and is worn around the neck like headphones for at least 3 hours per day.

Device: Sleep Wellness Device (BeCurie)

Inactive Sleep Wellness Device

SHAM COMPARATOR

This sleep wellness device is running an inactive program in the application (no electromagnetic stimulation).

Device: Sleep Wellness Device (BeCurie)

Interventions

Sleep Wellness Device (BeCurie) DEVICE

This device emits micro electromagnetic stimulation

Inactive Sleep Wellness Device; Sleep Wellness Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically elevated insomnia symptoms as defined by Insomnia Severity Index (ISI) score \>=15
• Able to read and write in English
• Smartphone user

You may not qualify if:

• History of chronic drug or alcohol abuse
• More than 400mg of caffeine per day
• Consistent travel across time zones throughout the study period
• Consistent migraine attacks or headaches
• Diagnosed sleep disorders other than insomnia
• Prescribed sleep medications or other treatments for insomnia (e.g. cognitive behavioral therapy)
• Untreated or unstable psychiatric disorders as defined by a PHQ8 score of greater than 15
• Using antipsychotic drugs
• Pregnant women or lactating women, or have an infant less than 6 months old
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
• A history of serious medical conditions (e.g. cancers, consistent hospitalizations)
• History of allergy or hypersensitivity to any medical device or its components
• Overnight work \>1 shift per month

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

• 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. J Clin Sleep Med. 2025 Jul 1;21(7):1285-1291. doi: 10.5664/jcsm.11690.

  PMID: 40165746 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Dr. Kelly Baron
• Organization: University of Utah

kelly.baron@utah.edu

8015857588

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Devices will appear the same but some devices will be placebo and some will be turned on as active. This is turned on remotely. A staff member who is blinded to the study screening and outcomes will conduct the randomization allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MPH

Model Details: For the first 28 days, participants will be randomized 1:1 to intervention vs. placebo. Following 28 days, all devices will be active from day 28 to 3 months.

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 19, 2023
• Study Start: September 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: July 17, 2024
• Last Updated: March 28, 2025
• Results First Posted: March 28, 2025

Record last verified: 2025-03

Locations

US (1)