Not yet recruiting NCT07633743
MenoZen VR for Menopause Symptom Management: Phase 2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MenoZen.
- Who it may be relevant to
- Registry conditions: Menopause. Basic parameters: 45 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device MenoZen
Participants will complete weekly self-administered virtual reality sessions via MenoZenVR, using a VR headset, for 8 consecutive weeks.
Primary outcome measures
- Change in frequency of hot flashes [Time frame: Baseline, 8 weeks]
- Change in severity of hot flashes [Time frame: Baseline, 8 weeks]
Secondary outcome measures (7)
- Change in Menopause-specific Quality of Life (MENQOL) Questionnaire score [Time frame: Baseline, 8 weeks]
- Change in Menopause Rating Scale (MRS) score [Time frame: Baseline, 8 weeks]
- System Usability Scale (SUS) score [Time frame: 8 weeks]
- Change in Simulator Sickness Questionnaire (SSQ) score [Time frame: Baseline, 8 weeks]
- Change in PROMIS Sleep Disturbance short-form score [Time frame: Baseline, 8 weeks]
- Change in PROMIS Depression short-form score [Time frame: Baseline, 8 weeks]
- Change in PROMIS Anxiety short-form score [Time frame: Baseline, 8 weeks]
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic — Jacksonville
Identifiers
NCT: NCT07633743 · 26-002719