A Novel Wearable Device for the Treatment of Insomnia

Sponsor

University of Utah (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05952297

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of the study is to help determine if a wearable sleep wellness device improves sleep among adults with insomnia. We 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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Device: Sleep Wellness Device (BeCurie)	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

A Novel Wearable Device for the Treatment of Insomnia

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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. It is worn around the neck like headphones for at least 3 hours per day. 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.	Device: Sleep Wellness Device (BeCurie) This device emits micro electromagnetic stimulation
Sham Comparator: Inactive Sleep Wellness Device This device is the sleep wellness device but is running a sham program in the application. The device appears to be activated (lights on) but there is no micro electromagnetic stimulation.	Device: Sleep Wellness Device (BeCurie) This device emits micro electromagnetic stimulation

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. It is worn around the neck like headphones for at least 3 hours per day. 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.

Device: Sleep Wellness Device (BeCurie)

This device emits micro electromagnetic stimulation

Sham Comparator: Inactive Sleep Wellness Device

This device is the sleep wellness device but is running a sham program in the application. The device appears to be activated (lights on) but there is no micro electromagnetic stimulation.

Device: Sleep Wellness Device (BeCurie)

This device emits micro electromagnetic stimulation

Outcome Measures

Primary Outcome Measures

Insomnia symptoms [Baseline to 28 days]
The insomnia severity index is a self-report item of insomnia symptoms that is well correlated with insomnia diagnoses.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Utah

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kelly Glazer Baron, PhD, MPH, University of Utah

ClinicalTrials.gov Identifier:

NCT05952297

Other Study ID Numbers:

00165943

First Posted:

Jul 19, 2023

Last Update Posted:

Jul 19, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kelly Glazer Baron, PhD, MPH, University of Utah

insomnia

sleep

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Jul 19, 2023