Muse Headband for Insomnia in Midlife Women
AK
Overseen byAmber 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
AK
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.
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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.
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Treatment Details
Interventions
- Muse-S™ headband system (Behavioural Intervention)
Trial OverviewThe 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
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 Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Trials
3,427
Recruited
3,221,000+