Amygdala Insula Retraining in the Management of Perimenopause Symptoms (NCT07427459) | Clinical Trial Compass
RecruitingNot Applicable
Amygdala Insula Retraining in the Management of Perimenopause Symptoms
United States160 participantsStarted 2026-07-15
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 range
38 Years – 60 Years
Sex
FEMALE
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 (-2 to +1c)
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Menopause Rating Scale (MRS) Total Score
Timeframe: Baseline (Week 0) to post-intervention (Week 12)