A Study of MUSE Device for Midlife Women
Completed · Not applicable
Conditions studied: Women's Health, Insomnia, Sleep Disturbance
In brief
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
Key facts
- Study ID
- NCT05972486
- Run by
- Mayo Clinic
- People needed
- 31
- Starts
- 2023-08-01
- Expected to finish
- 2025-01-12
- Last updated by the study team
- 2026-01-26
Who can join
Age: 45 and older, up to 65. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- Suspected or untreated 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.
Where it is running
- Mayo Clinic Minnesota — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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