← Back to Search

Muse Headband for Insomnia in Midlife Women

N/A
Recruiting
Led By Amber Klindworth, PA-C
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
PSQI score > 5, with overall sleep quality rating of 'fairly bad' or 'very bad'
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights

Study Summary

This trial tests if a brain sensing headband can help midlife women manage sleep disturbances like insomnia and disruption.

Who is the study for?
This trial is for midlife women experiencing menopause-related sleep disturbances who have access to a smart device and are motivated to improve their sleep. They must not be using supplements affecting sleep, have untreated significant psychiatric conditions, or be practicing mindfulness regularly.Check my eligibility
What is being tested?
The study tests the feasibility of using the Muse-S headband system by midlife women with insomnia or other sleep disorders. The headband senses brain activity and aims to help manage these disturbances.See study design
What are the potential side effects?
Since this trial involves a non-invasive device that monitors brain activity for managing sleep issues, side effects may be minimal but could include discomfort from wearing the headband or potential frustration if no improvement in sleep quality is perceived.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I often sleep poorly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in quality of sleep
Change in sleep impact
Secondary outcome measures
Change in perceived anxiety
Change in perceived stress levels
Change in quality of life
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Muse-S headband system for management of sleep disturbancesExperimental Treatment1 Intervention
Study participants will receive a new Muse-S headband system at study entry and will be asked to utilize it daily for a minimum of 10 minutes day for a period of 6 months (24 weeks). Three of the seven sessions per week will specifically be asked to be mind meditation.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,216 Previous Clinical Trials
3,767,438 Total Patients Enrolled
Amber Klindworth, PA-CPrincipal InvestigatorMayo Clinic

Media Library

Muse-S headband system for management of sleep disturbances Clinical Trial Eligibility Overview. Trial Name: NCT05972486 — N/A
Women's Health Research Study Groups: Muse-S headband system for management of sleep disturbances
Women's Health Clinical Trial 2023: Muse-S headband system for management of sleep disturbances Highlights & Side Effects. Trial Name: NCT05972486 — N/A
Muse-S headband system for management of sleep disturbances 2023 Treatment Timeline for Medical Study. Trial Name: NCT05972486 — N/A

Frequently Asked Questions

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

Who meets the criteria necessary to partake in this research effort?

"Eligibility for this trial is determined by a patient's sex and age bracket. Women aged 45 to 60 are invited to apply, with up to 50 candidates selected in total."

Answered by AI

Is this study open to those aged 70 and over?

"This particular trial requires participants to be aged between 45 and 60. By contrast, there are 42 trials for minors and 193 options available to seniors."

Answered by AI

Are there any current opportunities to sign up for this clinical experiment?

"According to the records on clinicaltrials.gov, this medical experiment is not presently recruiting participants; it was first advertised on August 1st 2023 and its details were last modified July 25th of that same year. Despite this trial's inactive status, there are currently 269 other studies actively seeking volunteers for their research."

Answered by AI

What are the primary goals of this clinical experiment?

"The purpose of this trial, which is to be monitored over Baseline, 3 months and 6 months, is to assess the impact on sleep. Other secondary objectives include measuring perceived anxiety with the Generalized Anxiety Disorder Scale (GAD-7) ranging in scores from 0-21; assessing female sexual functioning using the Female Sexual Function Index (FSFI), where lower scores indicate greater impairment; and gauging sexually related distress through the Female Sexual Distress Scale (FSDS-R). Scores for that questionnaire range from 0-60, higher numbers correlating with more acute levels of anguish."

Answered by AI

Who else is applying?

What site did they apply to?
Mayo Clinic Minnesota
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of MUSE Device for Midlife Women
Amber L. Klindworth 2023. "A Study of MUSE Device for Midlife Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05972486.
All > Sleep Disorder
~22 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top