Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 7:47 PM
Study NCT ID:
NCT07427459
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amygdala Insula Retraining in the Management of Perimenopause Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a 24-week, parallel-group, randomized, wait-list-controlled trial conducted remotely. A minimum of 160 perimenopausal participants aged 38 to 60 years will be randomized in a 1:1 ratio to either an active intervention arm or a wait-list control arm.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-16', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-02-16', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Menopause Rating Scale (MRS) Total Score', 'timeFrame': 'Baseline (Week 0) to post-intervention (Week 12)', 'description': 'Overall perimenopausal symptom burden as measured by the Menopause Rating Scale (MRS)'}], 'secondaryOutcomes': [{'measure': 'Greene Climacteric Scale', 'timeFrame': 'Baseline (Week 0) to post-intervention (Week 12)', 'description': 'Overall climacteric symptom severity'}, {'measure': 'Hot Flash Related Daily Interference Scale (HFRDIS)', 'timeFrame': 'Baseline (Week 0) to post-intervention (Week 12)', 'description': 'Impact of vasomotor symptoms on daily functioning'}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'Baseline (Week 0) to post-intervention (Week 12)', 'description': 'Subjective sleep disturbance and insomnia severity'}, {'measure': 'PROMIS Fatigue Short Form 8a', 'timeFrame': 'Baseline (Week 0) to post-intervention (Week 12)', 'description': 'Fatigue severity and impact'}, {'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'Baseline (Week 0) to post-intervention (Week 12)', 'description': 'Depressive symptoms'}, {'measure': 'Generalized Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'Baseline (Week 0) to post-intervention (Week 12)', 'description': 'Anxiety symptoms'}, {'measure': 'Patient Global Impression of Change (PGIC)', 'timeFrame': 'Assessed at Weeks 12 and 24', 'description': 'Overall perceived improvement'}, {'measure': 'Female Sexual Function Index (FSFI)', 'timeFrame': 'Baseline (Week 0) to post-intervention (Week 12) (optional)', 'description': 'Sexual function (optional)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Amygdala and Insula Retraining (AIR)'], 'conditions': ['Perimenopause']}, 'descriptionModule': {'briefSummary': '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.\n\nOur research questions include:\n\nDoes AIR reduce overall perimenopausal symptom burden compared to a wait-list control?\n\nDoes AIR improve sleep disturbance, vasomotor symptom interference, fatigue, mood, anxiety, and quality of life in perimenopausal individuals?\n\nAre symptom changes associated with improvements in autonomic regulation and sleep parameters, as reflected by exploratory wearable measures including heart rate variability?', 'detailedDescription': 'Perimenopause is a transitional reproductive stage marked by fluctuations in ovarian steroid hormones. It is often associated with sleep disruption, fatigue, mood changes, anxiety, cognitive changes, and diminished quality of life. Emerging evidence suggests that, in addition to hormonal changes, alterations in central threat processing, interoception, and autonomic nervous system regulation may contribute to symptom amplification and persistence during this period.\n\nAmygdala and Insula Retraining (AIR) is a structured, neuroplasticity-based behavioral intervention designed to modulate the autonomic nervous system. The program integrates cognitive reframing, somatic retraining, mindfulness practices, breathwork, behavioral pattern interruption, and safety-signal conditioning with the aim of calming hyper-reactive limbic pathways. Through repeated practice, AIR seeks to restore autonomic balance and reduce symptom burden.\n\nThis study is a 24-week, parallel-group, randomized, wait-list-controlled trial conducted remotely. A minimum of 160 perimenopausal participants aged 38 to 60 years will be randomized in a 1:1 ratio to either an active intervention arm or a wait-list control arm. Participants in the active intervention arm will receive immediate access to the 12-week AIR program in addition to treatment as usual. Participants in the wait-list control arm will continue treatment as usual for 12 weeks and will receive access to the recorded AIR intervention following completion of the primary endpoint assessment. Both groups will be followed through week 24.\n\nThe primary assessment is the the Menopause Rating Scale (MRS) total score from baseline (T0) to post-intervention at week 12 (T1). Secondary outcomes, assessed at baseline, week 12, and week 24, include insomnia severity, fatigue, anxiety, depression, patient global impression of change, and sexual function (optional). Concomitant therapies, including hormone replacement therapy and relevant medications, will be recorded at all assessment time points.\n\nAn exploratory wearable sub-study will be conducted in a randomly selected subset of approximately 50 participants distributed across both study arms. Wearable devices will be used to collect objective physiological measures, including heart rate variability, resting heart rate, sleep duration and efficiency, and activity metrics. These data will be analyzed descriptively to explore potential physiological correlates of symptom change.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '61 Years', 'minimumAge': '38 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Experiencing perimenopausal symptoms\n* Meets STRAW+10 criteria based on self-assessment\n* Able to read and understand English\n* Access to internet\n\nExclusion Criteria:\n\n* Pregnancy\n* Presence of a severe psychiatric condition requiring immediate clinical intervention\n* Uncontrolled thyroid disease or prolactinoma\n* Active cancer treatment\n* Inability to provide informed consent\n* Any medical or psychiatric condition that, in the judgment of the investigator or study team, would interfere with safe participation or study completion'}, 'identificationModule': {'nctId': 'NCT07427459', 'briefTitle': 'Amygdala Insula Retraining in the Management of Perimenopause Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Chronic Conditions Research Fund'}, 'officialTitle': 'Amygdala Insula Retraining in the Management of Perimenopause Symptoms', 'orgStudyIdInfo': {'id': 'CCRF-AIR-PM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amygdala insula retraining', 'description': 'Participants receive immediate access to the 12-week Amygdala and Insula Retraining (AIR) program in addition to treatment as usual.', 'interventionNames': ['Behavioral: Amygdala and Insula Retraining (AIR)']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants receive treatment as usual for 12 weeks and are offered access to the Amygdala and Insula Retraining (AIR) program after completion of the primary outcome assessment.'}], 'interventions': [{'name': 'Amygdala and Insula Retraining (AIR)', 'type': 'BEHAVIORAL', 'description': 'Mind-body brain retraining intervention', 'armGroupLabels': ['Amygdala insula retraining']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52101', 'city': 'Decorah', 'state': 'Iowa', 'country': 'United States', 'facility': 'Luther College Department of Psychology', 'geoPoint': {'lat': 43.30331, 'lon': -91.78571}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chronic Conditions Research Fund', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}