A Novel Wearable Device for the Treatment of Insomnia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Novel Wearable Device for the Treatment of Insomnia

Conditions
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Insomnia

Intervention / Treatment
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* Device: Sleep Wellness Device (BeCurie)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep Wellness Device<br>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)<br>* This device emits micro electromagnetic stimulation<br>|
| Sham Comparator: Inactive Sleep Wellness Device<br>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)<br>* This device emits micro electromagnetic stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia symptoms | The insomnia severity index is a self-report item of insomnia symptoms that is well correlated with insomnia diagnoses. | Baseline to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep, insomnia