Clinical Trial

Amygdala Insula Retraining in the Management of Perimenopause Symptoms

Recruiting

Summary

The goal of this study is to evaluate a neuroplasticity-based mind-body intervention, Amygdala and Insula Retraining (AIR), compared to a wait-list control in individuals experiencing perimenopausal symptoms. Our research questions include: Does AIR reduce overall perimenopausal symptom burden compared to a wait-list control? Does AIR improve sleep disturbance, vasomotor symptom interference, fatigue, mood, anxiety, and quality of life in perimenopausal individuals? Are symptom changes associated with improvements in autonomic regulation and sleep parameters, as reflected by exploratory wearable measures including heart rate variability?

Protocol Amendment History 4 changes

notable Primary completion pushed: 2026-12-31 -> 2027-01-31 2026-06-30

critical Recruitment opened 2026-06-13

notable Primary completion pushed: 2026-09-01 -> 2026-12-31 2026-06-13

minor Completion pushed: 2026-09-01 -> 2027-03-01 2026-06-13

Trial Details

NCT Number	NCT07427459
Lead Sponsor	Chronic Conditions Research Fund
Conditions	Perimenopause, Menopausal Complaints
Enrollment	160 participants
Start Date	2026-07-15
Primary Completion	2027-01-31 (estimated)
Study Completion	2027-03-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-29