Not Yet RecruitingNot Applicable

Amygdala Insula Retraining in the Management of Perimenopause Symptoms

United States160 participantsStarted 2026-03-01

Plain-language 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?

Who can participate

Age range38 Years – 61 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Experiencing perimenopausal symptoms * Meets STRAW+10 criteria based on self-assessment * Able to read and understand English * Access to internet Exclusion Criteria: * Pregnancy * Presence of a severe psychiatric condition requiring immediate clinical intervention * Uncontrolled thyroid disease or prolactinoma * Active cancer treatment * Inability to provide informed consent * Any medical or psychiatric condition that, in the judgment of the investigator or study team, would interfere with safe participation or study completion

What they're measuring

Menopause Rating Scale (MRS) Total Score

Timeframe: Baseline (Week 0) to post-intervention (Week 12)

Trial details

NCT IDNCT07427459

SponsorChronic Conditions Research Fund

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-01

View on ClinicalTrials.gov More Perimenopause trials