A Novel Wearable Device for the Treatment of Insomnia

March 29, 2024 updated by: Kelly Glazer Baron, University of Utah

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

BeCurie is a wearable sleep wellness device that contains specially designed coils that generate micro electromagnetic stimulation located in the neckband. This device is classified as a low risk wellness device that does not need FDA approval. It can be used by anyone aged 18 and above.

To test the efficacy of this device, a clinical study entitled "Prospective Observational Double-Blind Placebo-Controlled Randomised Clinical Study to Assess the Stress and Anxiety Improvement with BeCurie" was carried out. (CTRI Registration CTRI/2022/03/041445 )Compared to the placebo group, the treatment group showed improvements in all stress and anxiety-related parameters, showing the effectiveness of the BeCurie device in managing stress and anxiety in individuals with perceived stress and anxiety. Further, no changes were observed in blood profile, biochemistry, and physiological parameters in both groups. No adverse events or side effects were recorded during the study in both placebo and treatment arms, demonstrating BeCurie has been well tolerated.

Further testing is warranted to determine whether or not this device has an influence on the quality of sleep of those who wear it. Therefore the goal of this study is to test the effects of this sleep wellness device on sleep quality among adults with elevated insomnia symptoms. This study will test the sleep wellness device compared to a placebo device for changes in sleep over 28 days. Following this 28 day blinded trial, this study will study the effects of the device in an open label, one group study from 28 days to 3 months. This study is fully remote, with no in person office visits. All assessments will occur via web-based surveys, sleep wearable devices (fitbit) and text-message based sleep diaries.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sleep Wellness Device
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)
This device emits micro electromagnetic stimulation
Sham Comparator: Inactive Sleep Wellness Device
This sleep wellness device is running an inactive program in the application (no electromagnetic stimulation).
Device: Sleep Wellness Device (BeCurie)
This device emits micro electromagnetic stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia symptoms
Time Frame: Baseline to 28 days
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.
Baseline to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

Aether Mindtech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

July 11, 2023

First Submitted That Met QC Criteria

July 11, 2023

First Posted (Actual)

July 19, 2023

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00165943

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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