RecruitingNot Applicable

Impact of Earplugs on Mechanisms of Noise-Related Cardiovascular Disease

United States26 participantsStarted 2025-10-15

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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 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

What they're measuring

Stress-Associated Neural Activity

Timeframe: Baseline and 6 months

Arterial inflammation

Timeframe: Baseline and 6 months

Trial details

NCT IDNCT07148817

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-04-01

Contact for this trial

Alula Assefa

617-726-2393 aassefa2@mgh.harvard.edu

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