N/A
Completed N=31
A Study of MUSE Device for Midlife Women
Women's Health · Insomnia · Sleep Disturbances
Source: ClinicalTrials.gov NCT05972486 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcomePrimary: Change in Quality of Sleep — -3; -4; -1 score on a scale
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Quality of Sleep |
-3; -4; -1 | — |
| PRIMARY Sleep Impact |
18; 22; 23 | — |
| SECONDARY Perceived Stress Levels |
16; 12; 12 | — |
| SECONDARY Change in Perceived Anxiety |
-2; -2; 0 | — |
| SECONDARY Sexual Function |
18; 18; 21 | — |
| SECONDARY Sexual Distress |
23.5; 24; 18 | — |
| SECONDARY Change in Quality of Life |
-2; -2; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05972486). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.