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Headband that reads your brain waves may ease insomnia in menopausal women

NCT ID NCT05972486

Symptom relief Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a headband called Muse-S, which senses brain activity, could help midlife women with sleep problems like insomnia. Thirty-one women going through menopause wore the device at home. The goal was to see if it was practical and if it improved sleep quality and daytime function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Muse-S headband system (a wireless EEG headband that tracks brain activity and connects to a mobile app)
What this could lead to
If it works, this could offer a non-drug, at-home option to help midlife women sleep better.
What could go wrong
This was a small, early feasibility study with only 31 participants, so results may not apply to everyone. The device is not a cure for insomnia and may not work for all sleep issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

31 people

The number who actually took part.

Started

Aug 2023

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 65 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

insomnia Parasomnias sleep disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insomnia Sleep disturbance Women's health

Contacts and locations

Locations

  • Mayo Clinic Minnesota

    Rochester, Minnesota, 55905, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.