Women's HealthNCT05972486

A Study of MUSE Device for Midlife Women

A study testing Muse-S™ headband system in people with Women's Health and Insomnia, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 45 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Women's Health, Insomnia, Sleep Disturbance
What is being tested?: Muse-S™ headband system
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2023to 12 Jan 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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 join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic Minnesota
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: MUSE Device to Improve Sleep Quality in Midlife Women

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

Conditions: Women's Health, Insomnia, Sleep Disturbance
Being tested: Muse-S™ headband system
Medical subject headings: Sleep Initiation and Maintenance Disorders, Parasomnias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Muse-S™ headband systemDevice
Clinical grade, headband-style wireless EEG (electroencephalogram is a test used to evaluate the electrical activity in the brain) system and designed to interact with a mobile device (a smartphone or tablet). The device is a soft, stretchy band that fits around the forehead to the back of the head.

Study groups in NCT05972486
Study group	Role	What they receive
Muse-S headband system for management of sleep disturbances	Experimental	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. Receives: Device: Muse-S™ headband system

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Quality of Sleep
Measured using the self-reported Pittsburgh Sleep Quality Index (PSQI) to assess the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.
Measured: Baseline, 3 months, 6 months
Sleep Impact
Measured using the self-reported ASCQ-Me Sleep Impact Short Form. The 5-item questionnaire used to assess functioning and wellbeing in accordance with sleep. The questions in this assessment tool ask how often they felt sleep impacted specific activities during the the past 7 days. Possible answers include: 5 - never; 4 - rarely; 3 - sometimes; 2 - often, and 1 - always. Possible scores range from 5 to 25, with higher scores indicating a better outcome.
Measured: Baseline, 3 months, 6 months

Secondary outcomes (5)

Perceived Stress Levels
Measured using the self-reported Perceived Stress Scale (PSS). The 10-item questionnaire measures global perceived stress experienced by the participant over the preceding 30 days. The questions in this assessment tool ask how often the participant felt or thought a certain way during the past month. Possible answers include: 0 - never; 1 - almost never; 2 - sometimes; 3 - fairly often, and 4 - very often. Possible scores range from 0 to 40, with lower scores indicating a better outcome (less stress).
Measured: Baseline, 3 months, 6 months
Change in Perceived Anxiety
Measured using the self-reported Generalized Anxiety Disorder Scale (GAD-7). The 7-item questionnaire assess severity of generalized anxiety disorder. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score for the seven items ranges from 0 to 21 where 0 is no anxiety, 1-4 is minimal anxiety, 5-9 is mild anxiety, 10-14 is moderate anxiety, and 15-21 is severe anxiety. With higher scores indicating more severe anxiety.
Measured: Baseline, 3 months, 6 months
Sexual Function
Measured using the self-reported Female Sexual Function Index (FSFI). The 19-item questionnaire to assess the sexual functioning in women. The questions in this assessment tool ask participants about a specific sexual function within the past 4 weeks on a Likert scale range of 0-5. Total scores range from 2 to 36, with lower scores indicating worse sexual functioning.
Measured: Baseline, 3 months, 6 months
Sexual Distress
Measured using the Female Sexual Distress Scale (FSDS-R). The 13-item questionnaire to assess sexually related personal distress over the pas 30 days. The questions in this assessment tool asks how often the participant felt during the past month. Possible answers include: 0 - never; 1 - rarely; 2 - occasionally; 3 - frequently, and 4 - always. Possible scores range from 0 to 60, with higher scores indicating greater level of distress.
Measured: Baseline, 3 months, 6 months
Change in Quality of Life
Measured using the self-reported Patient Health Questionnaire (PHQ-9). The 9-item questionnaire used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score for the seven items ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression. With higher scores indicating more severe depression.
Measured: Baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202312 Jan 2025

First posted2 Aug 2023
Study start1 Aug 2023
Primary completion12 Jan 2025
Study completion12 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Women's HealthStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05972486
Sponsor's protocol ID: 23-000081
Status last verified: Jan 2026
First submitted: 25 Jul 2023
Last updated: 26 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Women's Health trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MUSE Device to Improve Sleep Quality in Midlife Women
ClinicalTrials.gov ID: NCT05972486
Acronym / sponsor ID: 23-000081
Conditions: Women's Health, Insomnia, Sleep Disturbance
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 1 Aug 2023 (actual)
Primary completion: 12 Jan 2025 (actual)
Study completion: 12 Jan 2025 (actual)
First posted: 2 Aug 2023 (actual)
Results: Posted 26 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Muse-S headband system for management of sleep disturbances	Experimental	Device: Muse-S™ headband systemStudy 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.

Who may qualify

Ages: 45 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Muse-S™ headband systemClinical grade, headband-style wireless EEG (electroencephalogram is a test used to evaluate the electrical activity in the brain) system and designed to interact with a mobile device (a smartphone or tablet). The device is a soft, stretchy band that fits around the forehead to the back of the head.	Device	Muse-S headband system for management of sleep disturbances

Primary outcome

Change in Quality of Sleep
Time frame: Baseline, 3 months, 6 months
Measured using the self-reported Pittsburgh Sleep Quality Index (PSQI) to assess the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.
Sleep Impact
Time frame: Baseline, 3 months, 6 months
Measured using the self-reported ASCQ-Me Sleep Impact Short Form. The 5-item questionnaire used to assess functioning and wellbeing in accordance with sleep. The questions in this assessment tool ask how often they felt sleep impacted specific activities during the the past 7 days. Possible answers include: 5 - never; 4 - rarely; 3 - sometimes; 2 - often, and 1 - always. Possible scores range from 5 to 25, with higher scores indicating a better outcome.

5 secondary outcomes

Perceived Stress Levels
Time frame: Baseline, 3 months, 6 months
Change in Perceived Anxiety
Time frame: Baseline, 3 months, 6 months
Sexual Function
Time frame: Baseline, 3 months, 6 months
Sexual Distress
Time frame: Baseline, 3 months, 6 months
Change in Quality of Life
Time frame: Baseline, 3 months, 6 months

Results and safety

Results posted to the registry on 26 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Muse-S Headband System for Management of Sleep Disturbances	31	14

Primary outcome: Change in Quality of Sleep

Time frame: Baseline, 3 months, 6 months. Mean (Inter-Quartile Range). Unit: score on a scale

Measure	Muse-S Headband System for Management of Sleep Disturbances n = 18
Baseline to 3 Months	-3 (-4 to -2)
Baseline to 6 Months	-4 (-9 to -3)
3 Months to 6 Months	-1 (-3 to 0)

Population analysed: 4 subjects are not included in the change in quality of sleep from baseline to 6-month or change in quality of sleep from 3 months to 6-months as only 14 subjects completed the study through the 6-month time point.

Primary outcome: Sleep Impact

Time frame: Baseline, 3 months, 6 months. Median (Full Range). Unit: score on a scale

Measure	Muse-S Headband System for Management of Sleep Disturbances n = 31
Baseline	18 (8 to 25)
3 Months	22 (14 to 25)
6 Months	23 (14 to 25)

Population analysed: 13 subjects are not included in the sleep impact score at 3 months as only 18 subjects completed the study through the 3-month time point. 17 subjects are not included in the sleep impact score at 6 months as only 14 subjects completed the study through the 6-month time point.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of informed consent through study completion, approximately 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Muse-S Headband System for Management of Sleep Disturbances	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amber Klindworth, PA-C principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Muse-S™ headband system in people with Women's Health and Insomnia, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Quality of Sleep (time frame: Baseline, 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05972486.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.