CompletedNo phase
A Study of MUSE Device for Midlife Women
Key facts
- Who runs it
- Mayo Clinic
- Where
- Rochester, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 31 people enrolled
- Started
- 1 Aug 2023
- Ended
- 12 Jan 2025
- Type of study
- Interventional
- Treatments tested
- Muse-S™ headband system
- Record updated
- 26 January 2026
Who can take part
- Age
- 45 years to 65 years
- Sex
- Women only
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Women in the menopause transition or in menopause, based on clinical assessment
- PSQI score > 5, with overall sleep quality rating of "fairly bad" or "very bad"
- Motivation VAS score equal to or greater than 5 with overall motivation rating of on a scale of 0-10 with 0 being not motivated at all and 10 being extremely motivated
- Access to an iPad, iPhone, or android device
- Have ability to provide informed consent
Who cannot take part
- Moderate to severe vasomotor symptoms warranting prescription medication use. The FDA categories for hot flash severity are classified as mild (sensation of heat without sweating), moderate (sensation of heat with sweating, able to continue activity), or severe (sensation of heat with sweating cause cessation of activity)
- Use of hormone therapy or hypnotic agents
- 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
- A known, active, untreated clinically significant psychiatric condition
- Suspected or untreated obstructive sleep apnea
- Use of supplements known to affect sleep
- Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis
Where in United States
- Mayo Clinic MinnesotaRochester, United StatesNo longer taking part
About the trial
What the trial wants to find out
The purpose of this study is to see if it is feasible for midlife women to wear a brain activity sensing headband (Muse-S) for management of sleep disturbances such as insomnia and sleep disruption
The group in the trial
- Muse-S headband system for management of sleep disturbancesTreatment being tested
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.
Treatment: Muse-S™ headband system
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- MUSE Device to Improve Sleep Quality in Midlife Women
- Record updated
- 26 January 2026