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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor