Amygdala and Insula Retraining Program for Reducing Perimenopause Symptoms in Women Aged 38 to 60

What this Trial Is About

Researchers are evaluating Amygdala and Insula Retraining AIR, a neuroplasticity-based mind-body intervention, for managing symptoms experienced during perimenopause. This study aims to compare AIR with a wait-list control group to see if it reduces overall symptom burden, including sleep problems, fatigue, mood changes, anxiety, and quality of life. The trial also explores how changes in symptoms relate to autonomic nervous system regulation and sleep patterns using wearable devices. Participants will be randomly assigned to one of two groups. One group receives immediate access to the 12-week AIR program alongside their usual treatment, while the other group continues their usual treatment for 12 weeks before accessing the recorded AIR program. The study lasts 24 weeks in total, with outcomes measured at baseline, 12 weeks, and 24 weeks. Approximately 160 perimenopausal individuals aged 38 to 60 will take part. During the study, participants will complete assessments including the Menopause Rating Scale and other measures related to sleep, fatigue, mood, anxiety, and sexual function. A subgroup of about 50 participants will wear devices to track heart rate variability, sleep quality, and activity levels. Researchers will monitor treatment use and collect data remotely. The primary outcome is change in menopause symptoms from baseline to 12 weeks, with follow-up assessments continuing through week 24.

Amygdala Insula Retraining in the Management of Perimenopause Symptoms