What side effects are associated with this type of intervention?

Common treatments for insomnia include cognitive-behavioral therapy for insomnia (CBT-I) and various pharmacologic agents. CBT-I, which is a nonpharmacologic approach, generally has minimal side effects but may require frequent in-person visits, which can be a practical limitation. Pharmacologic treatments, such as prescription sleeping pills, can have side effects including daytime drowsiness, dizziness, and dependency. Wearable sleep wellness devices, like the one being studied, aim to improve sleep quality with potentially fewer side effects, but specific data on their side effects are not yet well-documented.

What prior FDA approvals exist?

FDA-approved treatments for insomnia primarily include pharmacologic agents such as benzodiazepines, non-benzodiazepine hypnotics (e.g., zolpidem, eszopiclone), and melatonin receptor agonists (e.g., ramelteon). These medications aim to improve sleep onset and maintenance. Nonpharmacologic interventions, such as cognitive-behavioral therapy for insomnia (CBT-I), are also recommended. The wearable sleep wellness device being studied represents a novel, nonpharmacologic approach to improving sleep quality, potentially offering an alternative to traditional pharmacologic treatments.

What other types of research exist?

Promising alternatives to wearable sleep wellness devices for treating insomnia in 2024 include: 1) Cognitive Behavioral Therapy for Insomnia (CBT-I), especially virtual or synchronous delivery methods, which have shown efficacy in reducing insomnia severity. 2) Pharmacotherapy, with new developments in insomnia medications that are relevant to mental health disorders. 3) Home Sleep Apnea Testing (HSAT) combined with appropriate treatments for sleep-disordered breathing, which can improve sleep quality if sleep apnea is a contributing factor. These alternatives offer a range of options from behavioral to medical interventions, suitable for different patient needs.

← Back to Search

Behavioural Intervention

Wearable Device for Insomnia

Phase 1 & 2

Waitlist Available

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

A history of serious medical conditions (e.g. cancers, consistent hospitalizations)

Diagnosed sleep disorders other than insomnia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 28 days

Summary

This trial is testing a wearable device called BeCurie that uses small electromagnetic pulses to help adults with insomnia sleep better. The study will compare the device to a similar non-active device over several weeks and then continue to monitor its effects for a few months. The goal is to see if the device can improve sleep quality in people who have trouble sleeping.

Who is the study for?

This trial is for adults who struggle with insomnia, scoring at least 15 on the Insomnia Severity Index. Participants must be able to read and write in English and use a smartphone. Specific details about who cannot join are not provided.

What is being tested?

The study is examining if a wearable sleep wellness device (BeCurie) can improve sleep in individuals with insomnia over a period of 28 days and again after three months, compared to a placebo device. The participants will be split evenly into two groups by chance.

What are the potential side effects?

Potential side effects are not detailed in the information provided but could include discomfort from wearing the device or skin irritation.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of serious medical conditions.

Select...

I have a sleep disorder that is not insomnia.

Select...

I can travel across different time zones during the study.

Select...

My mental health is stable, with a PHQ8 score of 15 or less.

Select...

I am currently taking antipsychotic medication.

Select...

I am able to follow the study's procedures without any issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Insomnia symptoms

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Sleep Wellness DeviceExperimental Treatment1 Intervention

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.

Group II: Inactive Sleep Wellness DevicePlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sleep Wellness Device (BeCurie)

2023

Completed Phase 2

~70

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for insomnia include behavioral approaches like Cognitive Behavioral Therapy for Insomnia (CBT-I) and pharmacologic treatments such as melatonin and hypnotic medications. CBT-I focuses on modifying sleep habits and thought patterns through techniques like sleep restriction, stimulus control, and relaxation, aiming to reduce anxiety and promote a consistent sleep-wake schedule. Pharmacologic treatments work by influencing neurotransmitters and hormones that regulate sleep, such as melatonin for circadian rhythm adjustment and hypnotics that enhance GABA effects to induce sleep. The wearable sleep wellness device being studied likely uses non-pharmacologic methods, potentially involving biofeedback or behavioral techniques to improve sleep quality. Understanding these mechanisms helps insomnia patients and their healthcare providers select the most effective treatment tailored to their specific needs.

Telemedicine-delivered cognitive-behavioral therapy for insomnia in alcohol use disorder (AUD): study protocol for a randomized controlled trial.Managing insomnia in the primary care setting: raising the issues.