Status:
COMPLETED
A Study of MUSE Device for Midlife Women
Lead Sponsor:
Mayo Clinic
Conditions:
Women's Health
Insomnia
Eligibility:
FEMALE
45-65 years
Phase:
NA
Brief Summary
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
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Suspected or confirmed obstructive sleep apnea.
- 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 supplements known to affect sleep.
- A known, active, untreated clinically significant psychiatric condition.
- 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.
- Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2025
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05972486
Start Date
August 1 2023
End Date
January 12 2025
Last Update
May 13 2025
Active Locations (1)
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1
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905