Muse Headband for Insomnia in Midlife Women

Overseen by Amber Klindworth, PA-C

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Amber Klindworth, PA-C

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

I am going through or have completed menopause.

I often sleep poorly.

I rate my motivation for treatment as 5 or higher on a scale of 0 to 10.

Exclusion Criteria

Use of an investigational drug within 30 days of study enrollment or presence of a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence

I have been practicing mindfulness regularly for the past 3 weeks.

I experience moderate to severe hot flashes that require medication.

Treatment Details

Interventions

• Muse-S™ headband system (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: Muse-S headband system for management of sleep disturbances Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+