Amygdala Insula Retraining in the Management of Perimenopause Symptoms

Part of paid clinical trials in Decorah, Iowa.

Sponsor
Chronic Conditions Research Fund
Study ID
NCT07427459
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
38 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Amygdala and Insula Retraining (AIR) — BEHAVIORAL
    Mind-body brain retraining intervention

Study Details

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?

Key Dates

First listed
Feb 23, 2026
Start date
Jul 15, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Amygdala insula retraining
    Participants receive immediate access to the 12-week Amygdala and Insula Retraining (AIR) program in addition to treatment as usual.
  • No Intervention: Control
    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.

Primary Outcome Measure

Menopause Rating Scale (MRS) Total Score [ Time Frame: Baseline (Week 0) to post-intervention (Week 12) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Luther College Department of PsychologyDecorahIowa52101
Loren Toussaint, Ph.D., Ph.D. in Psychology
[email protected]
312-768-8649
Kate Research Manager
[email protected]
312-768-8649

Find similar trials in Decorah, IA

By condition
Menopause
By specialty
Women's healthFertility
By research site
Luther College Department of Psychology· Decorah, IA

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