Actively Recruiting
Impact of Earplugs on Mechanisms of Noise-Related Cardiovascular Disease
Led by Massachusetts General Hospital · Updated on 2025-11-03
26
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
A
American Heart Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of Earplugs on Mechanisms of Noise-Related Cardiovascular Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Feel annoyed by transportation noise or have high residential noise exposure (>45 dBA average over 24 hours) as per U.S. Department of Transportation Map
- Have known stable atherosclerosis or at least one typical risk factor such as hypertension, diabetes, active smoking, or high cholesterol
- Able to understand and sign informed consent
You will not qualify if you...
- History of stroke, brain surgery, or seizure
- Use of certain cardiovascular medications like beta-blockers, high-intensity statins (rosuvastatin 20/40 mg, atorvastatin 40/80 mg), or PCSK-9 inhibitors
- Change in psychiatric or cardiovascular medications within the past 3 months (stable regimens allowed)
- Unstable blood pressure or cardiac arrhythmia
- Current use of personal noise mitigation techniques or participation in a stress management program
- Moderate to severe alcohol or substance use disorder
- Current mania or psychosis
- Weight over 300 lbs
- Claustrophobia
- Pregnancy
- Presence of metal implants
- Uncontrolled high blood sugar (HgbA1c > 7.5%)
- Significant radiation exposure from research procedures (>2 nuclear tests, CT scans, or fluoroscopic procedures) in the past 12 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
A
Alula Assefa
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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