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Impact of Earplugs on Mechanisms of Noise-Related Cardiovascular Disease

RecruitingNAAges 18 Years - 65 YearsAllMassachusetts General Hospital
NCT07148817 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 investigat

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📋 Eligibility rules (as published)
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
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What it tests

  • Noise canceling earplugs
  • Usual care
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Where

1 site
Massachusetts General Hospital
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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