No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
45 – 60
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Mayo Clinic · Other
Who this trial is looking for
This trial is looking for women aged 45 to 60 who have moderate to severe hot flashes. Participants will use virtual reality sessions over 8 weeks to help manage their menopause symptoms.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman aged 45 to 60.
I have moderate to severe hot flashes.
I speak English.
I can participate fully in the study.
I have access to a computer or smartphone and home Wi-Fi.
I agree to participate in weekly VR sessions for 8 weeks.
You may not be able to join if
I am receiving hormonal therapy for menopause.
I am taking non-hormonal therapy for hot flashes.
I am currently in cognitive behavioral therapy for hot flashes.
I have a severe untreated psychiatric condition.
I have severe vision, hearing, or balance problems.
I have a facial deformity that prevents me from wearing VR equipment.
I have a history of severe motion sickness.
I had a seizure in the past year.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this research is to evaluate the feasibility, acceptability, tolerability, and clinical efficacy of MenoZen VR (virtual reality) for managing menopause symptoms in women.
Trial Locations
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Eligibility Criteria
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 a…
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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