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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