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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
Must not have
Suspected or confirmed obstructive sleep apnea
Moderate to severe vasomotor symptoms warranting prescription medication use (FDA categories for hot flash severity are classified as mild, moderate, or severe)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights

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
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I often sleep poorly.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or might have obstructive sleep apnea.
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I experience moderate to severe hot flashes that require medication.
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I am currently using hormone therapy or sleep medications.

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.

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 in Women's Health, such as the Muse-S headband for sleep management, hormone therapy, neurokinin receptor antagonists, and cognitive behavioral therapy (CBT), work through various mechanisms. The Muse-S headband monitors brain activity to help manage sleep disturbances. Hormone therapy balances estrogen and progesterone levels to alleviate menopausal symptoms like hot flashes. Neurokinin receptor antagonists block specific receptors to reduce vasomotor symptoms. CBT addresses psychological factors to improve sleep and reduce anxiety. Understanding these mechanisms allows for personalized treatment plans, enhancing efficacy and quality of life for Women's Health patients.
The effectiveness of activity scheduling and relaxation training in the treatment of spasmodic dysmenorrhea.Symptoms and self-care strategies in women with and without dysmenorrhea.Psychological and mind-body interventions for endometriosis: A systematic review.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,255 Previous Clinical Trials
3,835,356 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
~12 spots leftby Dec 2024