NCT07148817 Impact of Earplugs on Mechanisms of Noise-Related Cardiovascular Disease
| NCT ID | NCT07148817 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Cardiometabolic Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2025-10-15 |
| Primary Completion | 2028-04-01 |
Trial Parameters
Eligibility Fast-Check
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Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Current mania/psychosis * Weight \>300 lbs. * Claustrophobia * Pregnancy * Metal implan