AI Virtual Reality Program for Menopause Symptoms: Phase 2

Mayo Clinic has started recruiting patients for a Phase 2 trial testing MenoZen VR, an AI virtual reality program for menopause symptoms that delivers cognitive behavioral therapy through a headset instead of a therapist's office. The trial, registered as NCT07633743, started recruiting on Sept. 28 and is enrolling women ages 45 to 60 with moderate to severe hot flashes. It is the next test of whether an AI avatar can deliver CBT through VR, but the registry information does not yet show whether the study will compare MenoZen VR with another intervention.

Cognitive behavioral therapy already has a track record against hot flashes, insomnia, depression, and sexual dysfunction tied to menopause, The Menopause Society notes. The access problem is separate from the evidence supporting CBT for several menopause symptoms: finding someone qualified to deliver it remains the bottleneck. "Many women struggle to access evidence-based nonpharmacologic treatments for menopause symptoms because of barriers such as availability, cost, and convenience," said Dr. Stephanie Faubion, the Menopause Society's medical director and a study author.

About 80% of midlife women experience hot flashes and night sweats, yet only 1.7% of U.S. women used hormone therapy, the pharmacologic gold standard, in 2023, per Menopause Society data. That gap has fueled interest in nonhormonal options like CBT, and the proposed approach is meant to address those access barriers without requiring a therapist visit.

What is MenoZen VR cognitive behavioral therapy?

MenoZen VR runs on a Meta Quest 3S, a consumer headset rather than custom medical hardware. The clinical trial registry lists the program as MenoZenVR, written as one word; the Menopause Society refers to it as MenoZen VR. An AI-driven avatar named Maia guides participants through weekly modules blending CBT techniques, talk-therapy exercises, mindfulness, psychoeducation, and paced breathing, the Menopause Society says. Participants complete one self-administered session a week for eight consecutive weeks, according to the trial listing.

Dr. Karisma Suchak of Cedars-Sinai's Center for Virtual Medicine and Health System Transformation is identified as the lead author of the early results shared with the Menopause Society. She described those results carefully: the study "demonstrates early feasibility and acceptability" of using an AI-VR program to deliver evidence-based therapy and address access barriers, not proof that it reduces symptoms, she said.

MenoZen VR is not a new treatment. It is a new way of delivering one that already has evidence behind it, and whether the packaging changes the outcome is exactly what the Phase 2 trial is built to test.

Can virtual reality CBT for hot flashes help?

Findings specific to MenoZen VR so far come from a small, multicenter qualitative study, not from the Phase 2 trial itself. Results are being presented this week at The Menopause Society's annual meeting in San Diego, running Oct. 20 through 24, the organization says.

That study found midlife women highly interested in a personalized, nonpharmacologic program like MenoZen VR, according to the release. It reported no data on whether symptoms actually improved. Researchers were direct about that limit: "larger studies are needed to determine clinical effectiveness," though the findings suggest AI-enhanced VR "may offer a promising way to expand access" to CBT and similar therapies, according to the release.

The Phase 2 trial is designed to close that gap. Over eight weeks it will track hot-flash frequency and severity through a daily diary, a narrower measure sitting alongside broader outcomes also written into the protocol: sleep quality, depression, anxiety, menopause-specific quality of life, and system usability, per the study protocol. The registry lists July 31, 2027, as the primary completion date.

The registry information supplied for the trial does not specify a comparator arm or an enrollment target, so it is not yet possible to say how directly the results will measure MenoZen VR against other approaches.

Eligibility rules show where VR therapy has limits

To join, candidates must be women ages 45 to 60 experiencing at least 28 hot flashes a week, severe enough to have already prompted them to seek treatment. They cannot currently be using systemic hormone therapy, specified nonhormonal hot-flash treatments such as fezolinetant, elinzanetant, SSRIs, SNRIs, oxybutynin, or gabapentin, or active CBT for hot flashes, according to the trial listing. They also need English proficiency and access to a computer or smartphone plus home Wi-Fi.

The exclusion criteria screen for VR-specific risks as well: severe visual, auditory, or vestibular impairments; a facial or head shape that will not accommodate the headset; a history of acute motion sickness; or a seizure within the past year, per the registry. The protocol includes a 16-item Simulator Sickness Questionnaire administered at baseline and again after eight weeks, the listing shows. The VR protocol therefore has to assess tolerability as well as symptom change.

Removing the need for an in-person therapist could open CBT to people who cannot easily get an appointment, but a VR headset carries screening requirements a video call would not.

How MenoZen VR fits among other digital menopause tools

MenoZen VR is not the only digital approach being tested for menopause symptoms. The differences across these studies show where the open questions in digital menopause care actually sit.

A separate 149-person randomized trial tested Caria, a mobile app, against a web-based educational control over six weeks. The study reported significant improvements in vasomotor and behavioral-health symptoms among women using the app compared with the control group, according to the published study.

Mayo Clinic is also sponsoring an estimated 900-person trial of EMMII, a nonimmersive educational app built to help women recognize menopause symptoms and prepare a discussion guide for their next primary care visit, per the trial registration. That trial is currently listed as enrolling by invitation rather than open recruitment. Unlike MenoZen VR, EMMII is not trying to deliver therapy itself; it is trying to get patients talking to their doctors sooner.

A third approach skips apps and headsets altogether. A 38-person feasibility study is evaluating group Compassionate Mind Training, delivered through six 90-minute online sessions, for adults in the menopause transition, according to its registry entry. It is a lighter-touch intervention: no hardware, no avatar, just a video call and a cohort of peers.

Lined up together, the four programs evaluate different delivery models: immersive one-on-one VR therapy, a mobile app, group video sessions, and a pre-visit education tool. None of the supplied trial data compares these approaches against each other directly.

The Phase 2 trial is built to measure feasibility, tolerability, and symptom change over eight weeks, its registration shows, not to settle whether VR outperforms an app or a group video call. Results are not due before the trial's July 2027 primary completion date.

Until then, MenoZen VR remains a plausible answer to a documented access problem, with its real test still ahead: whether an avatar in a headset delivers anything that the larger EMMII trial, Caria's app, or a video-call-based program cannot.