Muse Headband for Insomnia in Midlife Women
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether the Muse-S headband can help midlife women manage sleep problems like insomnia. Participants will wear the headband daily for at least 10 minutes over six months and engage in specific meditation sessions. Women experiencing menopause and sleep difficulties may be suitable candidates, particularly if they rate their sleep quality as "fairly bad" or "very bad."
As an unphased trial, this study provides a unique opportunity for participants to explore innovative solutions for sleep issues.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking hormone therapy, hypnotic agents, and supplements known to affect sleep to participate in the trial.
What prior data suggests that the Muse-S headband system is safe for managing sleep disturbances in midlife women?
Research has shown that the Muse-S headband is safe and easy to use. One study found that using this brain-sensing device for guided meditation during work is both safe and comfortable, with no major side effects reported.
The Muse-S headband has also been compared to more expensive EEG systems that measure brain activity. It performed well in these tests and is even used by neuroscientists, supporting its reliability.
In summary, the Muse-S headband appears to be a safe choice for addressing sleep problems.12345Why are researchers excited about this trial?
The Muse-S™ headband system is unique because it offers a non-pharmacological approach to managing insomnia, specifically targeting midlife women. Unlike traditional treatments that often rely on medication, the Muse-S utilizes brain-sensing technology to promote relaxation and improve sleep quality through guided meditation sessions. Researchers are excited about its potential to offer a side-effect-free alternative to sleep medications, and its ease of use makes it accessible for daily integration into users' routines.
What evidence suggests that the Muse-S headband is effective for managing sleep disturbances in midlife women?
Research has shown that the Muse-S headband, which participants in this trial will use, effectively monitors and improves sleep. In one study, the headband tracked sleep data with 86% accuracy. Special sensors monitor brain activity, helping users understand their sleep patterns. The system also supports mindfulness practices, aiding relaxation and potentially improving sleep quality. Early users reported better sleep and overall well-being with regular use. These findings suggest that the Muse-S headband could be a promising tool for managing sleep problems like insomnia.678910
Who Is on the Research Team?
Amber Klindworth, PA-C
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a Muse-S headband system and are asked to use it daily for a minimum of 10 minutes, with three sessions per week focused on mind meditation
Follow-up
Participants are monitored for changes in sleep impact, quality of sleep, perceived stress, anxiety, sexual function, sexual distress, and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Muse-S™ headband system
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.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
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
Published Research Related to This Trial
Citations
1.
choosemuse.com
choosemuse.com/pages/brain-health-report?srsltid=AfmBOopPAAI5d966-Mo5aFFdwf1dc9RZ7WsmkEQ5EOfDXSZ1Kds0VfBA2024 Muse Brain Health Report
Self-reported scores across seven key brain health aspects (memory, focus, sleep, mood, productivity, creativity, and overall wellbeing)
Using a Wearable Brain Activity Sensing Device in the ...
Muse-S™ is a wearable brain S-EEG device which is a clinical-grade, headband-style wireless EEG system with 7 sensor and 4 channels of EEG data.
Revolutionizing Sleep Monitoring with the Muse S ...
Muse S Headband offers expert-level sleep monitoring at home, providing an accessible and convenient solution for sleep assessment.
Muse S Headband Review 2025
Replacement bands are available through Muse. Accuracy: An independent study found the Muse S Athena was 86% accurate in terms of data tracking.
The Benefit of Mindfulness-Based Intervention Using A ...
Primary Hypothesis: a) Post Covid patients enrolled in this study will find the Muse-S™ Headband system easy to use and will use it per protocol ...
1119 Validation of a Portable Sleep Electroencephalography ...
Portable EEG-based sleep monitoring with the MUSE-S shows good validity for sleep macroarchitecture variables relative to standard polysomnography.
NCT05972486 | A Study of MUSE Device for Midlife Women
Measured using the self-reported Pittsburgh Sleep Quality Index (PSQI) to assess the severity of sleep disturbances. Possible scores range from 0 to 21 with ...
Mindfulness Using a Wearable Brain Sensing Device for ...
Study results show that 3 to 10 min of guided meditation during work hours through the use of a brain sensing wearable device is safe and acceptable.
9.
choosemuse.com
choosemuse.com/pages/science?srsltid=AfmBOoqpwOvMYDo50MhPaNL6SVxvKHoktEjgcDsfyBMkA8MVnPrpDPZLScience | Muse® EEG Mental Fitness & Sleep Headband
Measurable & Accurate Results. Muse has been tested and validated against EEG systems that are exponentially more expensive, and it's used by neuroscientists ...
10.
choosemuse.com
choosemuse.com/blogs/news/revolutionizing-sleep-monitoring-with-the-muse-s-headband?srsltid=AfmBOopJy5KAdi0iJPFXvMv0JP1VuqRtVaiT-pf0j4lrlotQm831vdVMRevolutionizing Sleep Monitoring with the Muse S ...
Muse S Headband offers expert-level sleep monitoring at home, providing an accessible and convenient solution for sleep assessment.
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