PerimenopauseNCT07427459
Amygdala Insula Retraining in the Management of Perimenopause Symptoms
A study testing Amygdala and Insula Retraining (AIR) in people with Perimenopause and Menopausal Complaints, run by Chronic Conditions Research Fund at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 38 to 60 years, women only
- Conditions the study is for
- Perimenopause, Menopausal Complaints
- What is being tested?
- Amygdala and Insula Retraining (AIR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Experiencing perimenopausal symptoms
- Meets STRAW+10 criteria based on self-assessment (-2 to +1c)
- Able to read and understand English
- Access to internet
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Luther College Department of Psychology
Decorah, Iowa, 52101
Loren Toussaint, Ph.D., Ph.D. in Psychology, 312-768-8649 ext. Kate-R Manager, kate@ccrfund.org
Kate Research Manager, 312-768-8649, kate@ccrfund.org
About this study
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?
Read the detailed description
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.
Amygdala 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.
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. 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.
The 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.
An 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.
- Conditions
- Perimenopause, Menopausal Complaints
- Being tested
- Amygdala and Insula Retraining (AIR)
- Keywords
- Amygdala and Insula Retraining (AIR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amygdala and Insula Retraining (AIR)Behavioural
Mind-body brain retraining intervention
| Study group | Role | What they receive |
|---|---|---|
| Amygdala insula retraining | Experimental | Participants receive immediate access to the 12-week Amygdala and Insula Retraining (AIR) program in addition to treatment as usual. Receives: Behavioral: Amygdala and Insula Retraining (AIR) |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopause Rating Scale (MRS) Total Score
Overall perimenopausal symptom burden as measured by the Menopause Rating Scale (MRS). Scale: none (0)/extremely severe (4) - higher means worse outcome
Measured: Baseline (Week 0) to post-intervention (Week 12)
Secondary outcomes (8)
Greene Climacteric Scale
Overall climacteric symptom severity. Scale: not at all (0)/extremely (3) - higher means worse outcome
Measured: Baseline (Week 0) to post-intervention (Week 12)
Hot Flash Related Daily Interference Scale (HFRDIS)
Impact of vasomotor symptoms on daily functioning. Scale: do not interfere (0)/completely interfere (10) - higher means worse outcome
Measured: Baseline (Week 0) to post-intervention (Week 12)
Insomnia Severity Index (ISI)
Subjective sleep disturbance and insomnia severity. Scale: none (0)/very (4) - higher means worse outcome.
Measured: Baseline (Week 0) to post-intervention (Week 12)
PROMIS Fatigue Short Form 8a
Fatigue severity and impact. Scale: not at all or never (33)/ very much or always (78) - higher means worse outcome
Measured: Baseline (Week 0) to post-intervention (Week 12)
Patient Health Questionnaire-9 (PHQ-9)
Depressive symptoms. Scale: not at all (0)/nearly every day (3) and not difficult at all/extremely difficult - higher means worse outcome
Measured: Baseline (Week 0) to post-intervention (Week 12)
Generalized Anxiety Disorder-7 (GAD-7)
Anxiety symptoms. Scale: Not at all (0)/nearly every day (3) and not difficult at all/extremely difficult - higher means worse outcome
Measured: Baseline (Week 0) to post-intervention (Week 12)
Patient Global Impression of Change (PGIC)
Overall perceived improvement
Measured: Assessed at Weeks 12 and 24
Female Sexual Function Index (FSFI)
Sexual function (optional). Scale: 2.0/36.0 - higher means better outcome
Measured: Baseline (Week 0) to post-intervention (Week 12) (optional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start15 Jul 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a 24-week, parallel-group, randomized, wait-list-controlled trial conducted remotely. A minimum of 160 perimenopausal and early postmenopausal 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.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chronic Conditions Research Fund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427459
- Sponsor's protocol ID
- CCRF-AIR-PM
- Status last verified
- Jun 2026
- First submitted
- 16 Feb 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amygdala Insula Retraining in the Management of Perimenopause Symptoms
- ClinicalTrials.gov ID
- NCT07427459
- Acronym / sponsor ID
- CCRF-AIR-PM
- Conditions
- Perimenopause, Menopausal Complaints
- Keywords
- Amygdala and Insula Retraining (AIR)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Chronic Conditions Research FundUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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.
Amygdala 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.
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. 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.
The 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.
An 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a 24-week, parallel-group, randomized, wait-list-controlled trial conducted remotely. A minimum of 160 perimenopausal and early postmenopausal 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.
| Arm | Type | Receives |
|---|---|---|
| Amygdala insula retraining | Experimental | Behavioral: Amygdala and Insula Retraining (AIR)Participants receive immediate access to the 12-week Amygdala and Insula Retraining (AIR) program in addition to treatment as usual. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 38 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Experiencing perimenopausal symptoms
- Meets STRAW+10 criteria based on self-assessment (-2 to +1c)
- Able to read and understand English
- Access to internet
Key exclusion criteria (6 listed)
- Pregnancy
- Presence of a severe psychiatric condition requiring immediate clinical intervention
- Uncontrolled thyroid disease or prolactinoma
- Active cancer treatment
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amygdala and Insula Retraining (AIR)Mind-body brain retraining intervention | Behavioural | Amygdala insula retraining |
Primary outcome
Menopause Rating Scale (MRS) Total Score
Time frame: Baseline (Week 0) to post-intervention (Week 12)
Overall perimenopausal symptom burden as measured by the Menopause Rating Scale (MRS). Scale: none (0)/extremely severe (4) - higher means worse outcome
8 secondary outcomes
Greene Climacteric Scale
Time frame: Baseline (Week 0) to post-intervention (Week 12)
Hot Flash Related Daily Interference Scale (HFRDIS)
Time frame: Baseline (Week 0) to post-intervention (Week 12)
Insomnia Severity Index (ISI)
Time frame: Baseline (Week 0) to post-intervention (Week 12)
PROMIS Fatigue Short Form 8a
Time frame: Baseline (Week 0) to post-intervention (Week 12)
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline (Week 0) to post-intervention (Week 12)
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline (Week 0) to post-intervention (Week 12)
Patient Global Impression of Change (PGIC)
Time frame: Assessed at Weeks 12 and 24
Female Sexual Function Index (FSFI)
Time frame: Baseline (Week 0) to post-intervention (Week 12) (optional)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Perimenopause
Recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Not yet recruitingPhase 4
Migraine Menopause Study
Migraine, Menopausal
RecruitingObservational study
The Immunobiological Mechanisms of Depression in Perimenopause
Perimenopause, Major Depressive Episode (MDE)
Recruiting
Hemodynamics After Resistance Training
Perimenopause
Active, not recruiting
Relaxation Techniques and Pilates for Menopause Symptoms
Women Over 40 Years of Age in the Perimenopausal or Menopausal Stage, Presenting With Associated Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amygdala and Insula Retraining (AIR) in people with Perimenopause and Menopausal Complaints, run by Chronic Conditions Research Fund at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopause Rating Scale (MRS) Total Score (time frame: Baseline (Week 0) to post-intervention (Week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.