MenoZen VR for Menopause Symptom Management: Phase 2

MenoZen VR for Menopause Symptom Management: Phase 2

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.

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.