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Could a VR headset cool hot flashes? new study investigates

NCT ID NCT07633743

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether weekly virtual reality sessions can help manage menopause symptoms like hot flashes and night sweats. Women aged 45 to 60 who have at least 28 hot flashes per week will use a VR headset at home for 8 weeks. Researchers will track changes in hot flash frequency and severity, as well as overall quality of life.

What this could mean

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

Active substance
MenoZen VR (virtual reality headset sessions)
What this could lead to
If effective, MenoZen VR could offer a drug-free, non-hormonal option for managing hot flashes and improving quality of life during menopause.
What could go wrong
This is a small, early-phase feasibility study with only 40 participants. Results may not apply to all women, and the effect may be modest or no better than placebo.

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

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 60 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 currently between 45-60 years of age; * Have moderate to severe VMS, defined as 28 or more hot flashes per week (including night sweats) and were sufficient severity to prompt them to seek therapeutic intervention; * Are English-speaking; * Able to participate fully in all aspects of the study; * Have understood and signed study informed consent; * Have access to a computer or smartphone and home Wi-Fi; * Willing to participate in weekly VR sessions for 8 weeks. Exclusion Criteria: * Women receiving systemic menopause hormonal therapy (progesterone, testosterone, estrogen). Low-dose topical vaginal estrogen is okay; * Women receiving non-hormonal therapy for the management of hot flashes (fezolinetant or elinzanetant, any SSRI/SNRI, oxybytunin, and/or gabapentin being prescribed for hot flashes, if for other reasons and still with hot flashes then okay); * Women receiving active cognitive behavioral therapy (CBT) for hot flashes. CBT for mood symptoms is okay; * Have a known, active, untreated clinically significant psychiatric condition (severe depression, psychosis, bipolar disorder, or severe depression); * Have severe visual, auditory, or vestibular impairments that may interfere with VR use; * Have a facial/head deformity that will prohibit the wearing of a VR head mounted displace (HMD); * Self-reported history of acute and/or severe motion sickness; * Have had a seizure in the past year; * Concurrently enrolled in another intervention trial for menopause symptoms; * Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.

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As listed by the trial registrant

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

Menopause

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

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