Cardiometabolic DiseasesNCT07148817
Impact of Earplugs on Mechanisms of Noise-Related Cardiovascular Disease
A study testing Noise canceling earplugs in people with Cardiometabolic Diseases and Noise Exposure, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Noise from cars, planes, and trains affects all people and has been associated with heart disease. Almost 30% of Americans are exposed to harmful levels of noise and noise accounts for the loss of more than one million healthy life years per year in Europe. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiometabolic Diseases, Noise Exposure
- What is being tested?
- Noise canceling earplugs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2025to 30 Jun 2028
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Describe feeling annoyed by transportation noise exposure or have high residential noise exposure (>45 dBA average over 24 hours) using the United States Department of Transportation Map
- Known stable atherosclerosis or at least one typical risk factor (i.e., hypertension, diabetes, active smoking, or hyperlipidemia)
- Ability to understand and sign informed consent
Who cannot join
- History of stroke, brain surgery, or seizure
- Use of certain CVD medications (e.g., beta-blockers, high-intensity statins [e.g., rosuvastatin 20/40 mg and atorvastatin 40/80 mg], PCSK-9 inhibitors)
- Psychiatric or cardiovascular medication change within 3 months (i.e., stable regimen is allowed)
- Unstable blood pressure or cardiac arrhythmia
- Current use of personal noise mitigation techniques or involvement in stress management program
- Moderate/severe alcohol/substance use disorder
Show all 13Show fewer
- Current mania/psychosis
- Weight >300 lbs.
- Claustrophobia
- Pregnancy
- Metal implants
- Uncontrolled hyperglycemia (HgbA1c>7.5%)
- Subjects who have had significant radiation exposure as part of research (>2 nuclear tests, computed tomography images, or fluoroscopic procedures) during the preceding 12-months
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
Massachusetts General Hospital
Boston, Massachusetts, 02114
Michael Osborne, MD, mosborne@mgh.harvard.edu
About this study
Official title: Impact of Personal Mitigation on Mechanisms Linking Transportation Noise Exposure to Cardiometabolic Disease
Noise from cars, planes, and trains affects all people and has been associated with heart disease. Almost 30% of Americans are exposed to harmful levels of noise and noise accounts for the loss of more than one million healthy life years per year in Europe. Noise causes stress and may be most dangerous when it happens at night. The mechanisms linking noise to heart disease involve changes in the brain and the "fight or flight" response. These changes lead to inflammation and blood vessel disease. However, there are few laws that restrict noise and it is not addressed in medical care. Further, as cities and industries grow, noise continues to increase. Moreover, noise often occurs in areas that are also exposed to other stressors like high air pollution and low income. Yet, there is little research on noise, and it is not known if lowering noise exposure helps heart health. The investigators will use imaging to test if earplugs that block noise improve stress symptoms and changes in the the brain, blood vessels, and stress pathways that lead to disease. The investigators expect that people who use earplugs will have lower measures of stress and heart disease at follow-up. The study will include 26 people with heart disease risk with high noise exposure or who are annoyed by noise. At the first visit, subjects will have imaging of the brain and blood vessels and will have assessments of stress, inflammation, and the "fight or flight" response. They will be assigned to use earplugs or not after the first visit. After 6 months, imaging and other testing will be repeated. It will help to understand how noise impacts the body and whether the effects can be changed. It may also identify important treatments to prevent heart disease in people exposed to noise. By testing if the adverse effects of noise can be lowered with earplugs, this project supports the AHA's mission to be a force for a world of longer and healthier lives.
Read the detailed description
Transportation noise is a pervasive exposure in modern life that has been associated with cardiovascular and metabolic disease. Almost 30% of Americans are exposed to harmful levels of noise and noise accounts for the loss of more than one million healthy life years per year in Europe. Noise exposure leads to activation of the stress response and nocturnal exposure may be more dangerous. The pathologic mechanisms linking noise to cardiovascular disease have recently been shown to involve changes in the metabolic activity of stress responsive brain regions (specifically the ratio of activity in the amygdala to that of the cortex or stress-associated neural activity, SNA) and fluorodeoxyglucose positron emission tomography, FDG PET) and autonomic dysfunction. These changes lead to stress hormone release, inflammation, vascular dysfunction, oxidative stress, increased cardiovascular risk factors, and, ultimately, atherosclerosis. However, there are few laws that restrict noise and it is not addressed in routine medical care. Further, as cities and industries grow, noise exposure continues to increase. Moreover, noise exposure often occurs coincidentally with other psychosocial and environmental stressors, such as high air pollution and low income. Yet, there is little research on noise, and it is not known if personal noise mitigation attenuates the stress response and downstream markers of cardiovascular risk. The investigators will leverage will use advanced FDG PET/magnetic resonance imaging to test if noise canceling earplugs improve stress symptoms and reduce SNA, arterial inflammation, and autonomic and inflammatory intermediaries. The study will assess whether earplug use will decrease SNA and arterial inflammation by attenuating autonomic and inflammatory intermediaries. The investigators will recruit 26 people with cardiovascular risk with high noise exposure or annoyance for this pilot study. At baseline, subjects will have FDG PET/MRI of the brain and aorta and will have assessments of stress, inflammation, and autonomic function. They will be randomized to use earplugs or control. After 6 months, the baseline visit will be repeated. This study will clarify how noise impacts the body and whether its adverse effects can be reduced. It may also identify novel treatments to prevent heart disease in people exposed to noise. By testing if the adverse effects of noise can be mitigated with earplugs, this study takes a necessary step towards reducing noise-related cardiovascular disease.
- Conditions
- Cardiometabolic Diseases, Noise Exposure
- Being tested
- Noise canceling earplugs, Usual care
- Keywords
- Transportation Noise, Cardiometabolic Diseases, Earplugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noise canceling earplugsBehavioural
Modifiable noise cancelling earplugs will be used to attempt to limit individual noise exposure in those with high levels of exposure or high levels of annoyance related to noise
Usual careBehavioural
No behavioral changes to limit noise exposure
| Study group | Role | What they receive |
|---|---|---|
| Earplug use | Active comparator | Individuals assigned to this group will use earplugs to attenuate noise <45 dB during sleep and rest during the 6 month study period Receives: Behavioral: Noise canceling earplugs |
| Control | Placebo comparator | Individuals assigned to this group will not attempt noise mitigation during sleep and rest during the 6 month study period Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress-Associated Neural Activity
Measured on FDG-PET as the ratio of metabolic activity of the amygdala to that of the cortex.
Measured: Baseline and 6 months
Arterial inflammation
Measured as radiotracer uptake in the wall of the thoracic aorta relative to background venous blood uptake via FDG-PET imaging
Measured: Baseline and 6 months
Secondary outcomes (14)
Heart rate variability
Calculated from the average resting heart rate variability collected at baseline and post-treatment visits
Measured: Baseline and 6 months
Lifestyle factors
Self-reported survey results on diet, sleep, and exercise
Measured: Baseline and 6 months
Earplug use
Time log of earplug use during the study intervention
Measured: 6 months
Stress surveys
Self-reported assessments of perceived stress, noise annoyance, and symptoms of depression and anxiety
Measured: Baseline and 6 months
HOMA-IR
Measure of insulin sensitivity performed by blood sample
Measured: Baseline and 6 months
Leukopoiesis
Measured as bone marrow activity via FDG-PET imaging
Measured: Baseline and 6 months
Blood pressure
Systolic and diastolic pressure
Measured: Baseline and 6 months
MRI based arterial plaque components (such as necrotic tissue and hemorrhage)
MRI measurements of atherosclerotic plaque components including necrotic tissue and hemorrhage using black-blood imaging techniques
Measured: Baseline and 6 months
MRI based arterial wall thickness
Measurements of wall thickness as an assessment of atherosclerotic plaque
Measured: Baseline and 6 months
MRI based brain structure assessments of volume
Structural assessment of brain centers to assess volume of neural centers involved in the stress response
Measured: Baseline and 6 months
MRI based brain connectivity (by measuring changes in blood flow across networks of neural centers at rest and with an emotional task)
Connectivity assessment using mapping on functional MRI at baseline and in response to emotional faces of neural centers involved in the stress response to determine the interplay between neural centers before and after therapy by measuring alterations in blood oxygen content under various conditions in different parts of the brain
Measured: Baseline and 6 months
MRI based brain activation (via measuring blood flow in important neural centers at rest and with an emotional task using functional MRI)
Activation assessment using functional MRI at both rest and in response to emotional faces of neural centers involved in the stress response before and after therapy by measuring blood flow under various conditions to different parts of the brain
Measured: Baseline and 6 months
Axonal integrity of resting neural connections between brain centers using MRI
Measurement of axonal integrity using diffusion tensor imaging on MRI to determine the strength connections between important brain centers and neural networks related to stress perception before and after earplugs
Measured: Baseline and 6 months
MRI based brain structure assessments of density
Structural assessment of brain centers to evaluate the density of neural centers involved in the stress response
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start15 Oct 2025
- Primary completion1 Apr 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiometabolic DiseasesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Michael T. Osborne, Massachusetts General Hospital
- Investigators
- Michael Osborne, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148817
- Sponsor's protocol ID
- 2025P001821
- Other IDs
- 25TPA1474746
- Status last verified
- Oct 2025
- First submitted
- 18 Aug 2025
- Last updated
- 3 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data necessary for the replication of study results will be made available in deidentified fashion. This includes numerical measurements from imaging, blood tests, and surveys.
Publications
Osborne MT, Radfar A, Hassan MZO, Abohashem S, Oberfeld B, Patrich T, Tung B, Wang Y, Ishai A, Scott JA, Shin LM, Fayad ZA, Koenen KC, Rajagopalan S, Pitman RK, Tawakol A. A neurobiological mechanism linking transportation noise to cardiovascular disease in humans. Eur Heart J. 2020 Feb 1;41(6):772-782. doi: 10.1093/eurheartj/ehz820.
PubMed 31769799Osborne MT, Naddaf N, Abohashem S, Radfar A, Ghoneem A, Dar T, Wang Y, Patrich T, Oberfeld B, Tung B, Pitman RK, Mehta NN, Shin LM, Lo J, Rajagopalan S, Koenen KC, Grinspoon SK, Fayad ZA, Tawakol A. A neurobiological link between transportation noise exposure and metabolic disease in humans. Psychoneuroendocrinology. 2021 Sep;131:105331. doi: 10.1016/j.psyneuen.2021.105331. Epub 2021 Jun 17.
PubMed 34183223Sorensen M, Pershagen G, Thacher JD, Lanki T, Wicki B, Roosli M, Vienneau D, Cantuaria ML, Schmidt JH, Aasvang GM, Al-Kindi S, Osborne MT, Wenzel P, Sastre J, Fleming I, Schulz R, Hahad O, Kuntic M, Zielonka J, Sies H, Grune T, Frenis K, Munzel T, Daiber A. Health position paper and redox perspectives - Disease burden by transportation noise. Redox Biol. 2024 Feb;69:102995. doi: 10.1016/j.redox.2023.102995. Epub 2023 Dec 18.
PubMed 38142584
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Personal Mitigation on Mechanisms Linking Transportation Noise Exposure to Cardiometabolic Disease
- ClinicalTrials.gov ID
- NCT07148817
- Acronym / sponsor ID
- 2025P001821
- Conditions
- Cardiometabolic Diseases, Noise Exposure
- Keywords
- Transportation Noise, Cardiometabolic Diseases, Earplugs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 29 Aug 2025 (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.
Noise from cars, planes, and trains affects all people and has been associated with heart disease. Almost 30% of Americans are exposed to harmful levels of noise and noise accounts for the loss of more than one million healthy life years per year in Europe. Noise causes stress and may be most dangerous when it happens at night. The mechanisms linking noise to heart disease involve changes in the brain and the "fight or flight" response. These changes lead to inflammation and blood vessel disease. However, there are few laws that restrict noise and it is not addressed in medical care. Further, as cities and industries grow, noise continues to increase. Moreover, noise often occurs in areas that are also exposed to other stressors like high air pollution and low income. Yet, there is little research on noise, and it is not known if lowering noise exposure helps heart health. The investigators will use imaging to test if earplugs that block noise improve stress symptoms and changes in the the brain, blood vessels, and stress pathways that lead to disease. The investigators expect that people who use earplugs will have lower measures of stress and heart disease at follow-up. The study will include 26 people with heart disease risk with high noise exposure or who are annoyed by noise. At the first visit, subjects will have imaging of the brain and blood vessels and will have assessments of stress, inflammation, and the "fight or flight" response. They will be assigned to use earplugs or not after the first visit. After 6 months, imaging and other testing will be repeated. It will help to understand how noise impacts the body and whether the effects can be changed. It may also identify important treatments to prevent heart disease in people exposed to noise. By testing if the adverse effects of noise can be lowered with earplugs, this project supports the AHA's mission to be a force for a world of longer and healthier lives.
Detailed description
Transportation noise is a pervasive exposure in modern life that has been associated with cardiovascular and metabolic disease. Almost 30% of Americans are exposed to harmful levels of noise and noise accounts for the loss of more than one million healthy life years per year in Europe. Noise exposure leads to activation of the stress response and nocturnal exposure may be more dangerous. The pathologic mechanisms linking noise to cardiovascular disease have recently been shown to involve changes in the metabolic activity of stress responsive brain regions (specifically the ratio of activity in the amygdala to that of the cortex or stress-associated neural activity, SNA) and fluorodeoxyglucose positron emission tomography, FDG PET) and autonomic dysfunction. These changes lead to stress hormone release, inflammation, vascular dysfunction, oxidative stress, increased cardiovascular risk factors, and, ultimately, atherosclerosis. However, there are few laws that restrict noise and it is not addressed in routine medical care. Further, as cities and industries grow, noise exposure continues to increase. Moreover, noise exposure often occurs coincidentally with other psychosocial and environmental stressors, such as high air pollution and low income. Yet, there is little research on noise, and it is not known if personal noise mitigation attenuates the stress response and downstream markers of cardiovascular risk. The investigators will leverage will use advanced FDG PET/magnetic resonance imaging to test if noise canceling earplugs improve stress symptoms and reduce SNA, arterial inflammation, and autonomic and inflammatory intermediaries. The study will assess whether earplug use will decrease SNA and arterial inflammation by attenuating autonomic and inflammatory intermediaries. The investigators will recruit 26 people with cardiovascular risk with high noise exposure or annoyance for this pilot study. At baseline, subjects will have FDG PET/MRI of the brain and aorta and will have assessments of stress, inflammation, and autonomic function. They will be randomized to use earplugs or control. After 6 months, the baseline visit will be repeated. This study will clarify how noise impacts the body and whether its adverse effects can be reduced. It may also identify novel treatments to prevent heart disease in people exposed to noise. By testing if the adverse effects of noise can be mitigated with earplugs, this study takes a necessary step towards reducing noise-related cardiovascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Earplug use | Active comparator | Behavioral: Noise canceling earplugsIndividuals assigned to this group will use earplugs to attenuate noise <45 dB during sleep and rest during the 6 month study period |
| Control | Placebo comparator | Behavioral: Usual careIndividuals assigned to this group will not attempt noise mitigation during sleep and rest during the 6 month study period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Describe feeling annoyed by transportation noise exposure or have high residential noise exposure (>45 dBA average over 24 hours) using the United States Department of Transportation Map
- Known stable atherosclerosis or at least one typical risk factor (i.e., hypertension, diabetes, active smoking, or hyperlipidemia)
- Ability to understand and sign informed consent
Key exclusion criteria (13 listed)
- History of stroke, brain surgery, or seizure
- Use of certain CVD medications (e.g., beta-blockers, high-intensity statins [e.g., rosuvastatin 20/40 mg and atorvastatin 40/80 mg], PCSK-9 inhibitors)
- Psychiatric or cardiovascular medication change within 3 months (i.e., stable regimen is allowed)
- Unstable blood pressure or cardiac arrhythmia
- Current use of personal noise mitigation techniques or involvement in stress management program
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 |
|---|---|---|
| Noise canceling earplugsModifiable noise cancelling earplugs will be used to attempt to limit individual noise exposure in those with high levels of exposure or high levels of annoyance related to noise | Behavioural | Earplug use |
| Usual careNo behavioral changes to limit noise exposure | Behavioural | Control |
Primary outcome
Stress-Associated Neural Activity
Time frame: Baseline and 6 months
Measured on FDG-PET as the ratio of metabolic activity of the amygdala to that of the cortex.
Arterial inflammation
Time frame: Baseline and 6 months
Measured as radiotracer uptake in the wall of the thoracic aorta relative to background venous blood uptake via FDG-PET imaging
14 secondary outcomes
Heart rate variability
Time frame: Baseline and 6 months
Lifestyle factors
Time frame: Baseline and 6 months
Earplug use
Time frame: 6 months
Stress surveys
Time frame: Baseline and 6 months
HOMA-IR
Time frame: Baseline and 6 months
Leukopoiesis
Time frame: Baseline and 6 months
Blood pressure
Time frame: Baseline and 6 months
MRI based arterial plaque components (such as necrotic tissue and hemorrhage)
Time frame: Baseline and 6 months
MRI based arterial wall thickness
Time frame: Baseline and 6 months
MRI based brain structure assessments of volume
Time frame: Baseline and 6 months
MRI based brain connectivity (by measuring changes in blood flow across networks of neural centers at rest and with an emotional task)
Time frame: Baseline and 6 months
MRI based brain activation (via measuring blood flow in important neural centers at rest and with an emotional task using functional MRI)
Time frame: Baseline and 6 months
Axonal integrity of resting neural connections between brain centers using MRI
Time frame: Baseline and 6 months
MRI based brain structure assessments of density
Time frame: Baseline and 6 months
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 3 Nov 2025.
- Background: PubMed 31769799Osborne MT, Radfar A, Hassan MZO, Abohashem S, Oberfeld B, Patrich T, Tung B, Wang Y, Ishai A, Scott JA, Shin LM, Fayad ZA, Koenen KC, Rajagopalan S, Pitman RK, Tawakol A. A neurobiological mechanism linking transportation noise to cardiovascular disease in humans. Eur Heart J. 2020 Feb 1;41(6):772-782. doi: 10.1093/eurheartj/ehz820.
- Background: PubMed 34183223Osborne MT, Naddaf N, Abohashem S, Radfar A, Ghoneem A, Dar T, Wang Y, Patrich T, Oberfeld B, Tung B, Pitman RK, Mehta NN, Shin LM, Lo J, Rajagopalan S, Koenen KC, Grinspoon SK, Fayad ZA, Tawakol A. A neurobiological link between transportation noise exposure and metabolic disease in humans. Psychoneuroendocrinology. 2021 Sep;131:105331. doi: 10.1016/j.psyneuen.2021.105331. Epub 2021 Jun 17.
- Background: PubMed 38142584Sorensen M, Pershagen G, Thacher JD, Lanki T, Wicki B, Roosli M, Vienneau D, Cantuaria ML, Schmidt JH, Aasvang GM, Al-Kindi S, Osborne MT, Wenzel P, Sastre J, Fleming I, Schulz R, Hahad O, Kuntic M, Zielonka J, Sies H, Grune T, Frenis K, Munzel T, Daiber A. Health position paper and redox perspectives - Disease burden by transportation noise. Redox Biol. 2024 Feb;69:102995. doi: 10.1016/j.redox.2023.102995. Epub 2023 Dec 18.
- Individual participant dataSharing planned: Yes. Data necessary for the replication of study results will be made available in deidentified fashion. This includes numerical measurements from imaging, blood tests, and surveys.
Related trials for Cardiometabolic Diseases
Recruiting
Differentiating Heart Disease Between Adult-onset Autoimmune and Type 2 Diabetes
Diabete Mellitus, Autoimmune Diabetes
Not yet recruitingObservational study
Qatar Cardiometabolic Cohort
Cardiometabolic Diseases
Recruiting
Effects of a Specialized Diabetes and Heart Clinic and Detection of Unrecognized Heart Failure in People With Type 2 Diabetes and Cardiovascular Disease
Cardiovascular Disease, Cardiometabolic Diseases
Recruiting
Sustainable Diets and Cardiometabolic Health
Cardiometabolic Diseases
Recruiting
GENESIS: Genotype Guided - Natriuretic Peptides - Cardiometabolic Health Study
Cardiovascular Diseases, Natriuretic Peptides
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.
Michael Osborne, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noise canceling earplugs in people with Cardiometabolic Diseases and Noise Exposure, run by Massachusetts General Hospital 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 3 inclusion and 13 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 3 Nov 2025. 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. Some participants in this study may receive a placebo. 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?
Contact Alula Assefa (617-726-2393, aassefa2@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress-Associated Neural Activity (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07148817, which also lists 3 linked publications.
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 3 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.