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Behavioural Intervention

Sleep Wellness 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 28 days

Awards & highlights

Study Summary

This trial aims to see if a wearable sleep device can help adults with insomnia sleep better. They will enroll 60 participants and randomly assign them to either the treatment group or the control group. The study

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Aether MindtechUNKNOWN

University of UtahLead Sponsor

1,099 Previous Clinical Trials

1,778,623 Total Patients Enrolled

3 Trials studying Insomnia

151 Patients Enrolled for Insomnia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants being admitted into this clinical study?

"Indeed, the details on clinicaltrials.gov indicate that this study is actively seeking participants. The trial was initially posted on September 1st, 2023 and last updated on February 2nd, 2024. It aims to enroll 60 individuals at a single site."

Answered by AI

What are the potential risks associated with utilizing the Sleep Wellness Device in patients?

"Based on our evaluation at Power, the safety rating for the Sleep Wellness Device is a 2 on a scale from 1 to 3. This assessment stems from being in Phase 2 of clinical trials where there's preliminary safety data available but no evidence yet supporting its efficacy."

Answered by AI

Are there any available positions for patients to participate in this clinical trial?

"Indeed, the information on clinicaltrials.gov indicates that this investigation is actively enrolling subjects. The trial was first listed on September 1st, 2023 and most recently revised on February 2nd, 2024. This study aims to recruit a total of 60 individuals from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Novel Wearable Device for the Treatment of Insomnia

Kelly Glazer Baron 2023. "A Novel Wearable Device for the Treatment of Insomnia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05952297.

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