What side effects are associated with this type of intervention?

Common treatments for women's health issues, particularly those related to sleep disturbances and menopausal symptoms, include hormone therapy, herbal supplements, and non-pharmacological interventions like exercise. Hormone therapy can cause side effects such as headaches, scalp pain, and feeling cold. Herbal supplements like black cohosh and phytoestrogens generally have minimal side effects but lack strong evidence for efficacy. Non-pharmacological interventions like exercise are low-risk but require more research to confirm their benefits.

What prior FDA approvals exist?

The Muse-S Headband study focuses on managing sleep disturbances in midlife women. While there are no specific FDA approvals for brain activity monitoring devices like the Muse-S for sleep management, there are several FDA-approved treatments for related conditions in women's health. For instance, non-hormonal medications such as gabapentin and selective serotonin reuptake inhibitors (SSRIs) like paroxetine and fluoxetine have been approved for managing menopausal symptoms, including sleep disturbances. Additionally, cognitive-behavioral therapy (CBT) is a recognized non-pharmacological treatment for insomnia. These treatments highlight the FDA's focus on addressing sleep and related disturbances in women's health.

What other types of research exist?

Promising alternatives to the Muse-S headband for sleep management in women's health include: 1) Empatica E4 wristband, which monitors blood volume pulse, 3-axis accelerometer data, temperature, and electrodermal activity; 2) Fitbit Charge 2, which provides sleep and heart rate estimates; and 3) other consumer-grade multisensor wearables that have been validated for sleep and circadian biomarker monitoring. These devices offer comprehensive data collection and have been used in clinical and research settings.

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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 is testing if midlife women can use a special headband to manage sleep problems like insomnia. The headband monitors brain activity to provide feedback that can help improve sleep patterns.

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.

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.

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:

Select...

I have or might have obstructive sleep apnea.

Select...

I experience moderate to severe hot flashes that require medication.

Select...

I am currently using hormone therapy or sleep medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months

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

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

Primary study objectives

Change in quality of sleep

Change in sleep impact

Secondary study objectives

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.

0 / 4Eligibility 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 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

3,298 Previous Clinical Trials

3,958,395 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

~6 spots leftby Dec 2024

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