A Novel Wearable Device for the Treatment of Insomnia

Insomnia Clinical Trial

Official title:

A Novel Wearable Device for the Treatment of Insomnia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05952297
• Other study ID #: 00165943
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: September 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2024
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: July 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• Sleep Wellness Device (BeCurie)
This device emits micro electromagnetic stimulation

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Aether Mindtech

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 28 days