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Muse Headband for Insomnia in Midlife Women
N/A
Waitlist Available
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
No Placebo-Only Group
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 belowSelect...
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
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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
3,362 Previous Clinical Trials
3,065,911 Total Patients Enrolled
Amber Klindworth, PA-CPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been practicing mindfulness regularly for the past 3 weeks.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.I experience moderate to severe hot flashes that require medication.I am currently using hormone therapy or sleep medications.You are taking supplements that can affect your sleep.You have a serious mental health condition that is not being treated.You need to have an iPad, iPhone, or Android device.I have or might have obstructive sleep apnea.
Research Study Groups:
This trial has the following groups:- Group 1: Muse-S headband system for management of sleep disturbances
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.