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RECRUITING
NCT07148817
NA

Impact of Earplugs on Mechanisms of Noise-Related Cardiovascular Disease

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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.

Official title: Impact of Personal Mitigation on Mechanisms Linking Transportation Noise Exposure to Cardiometabolic Disease

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2025-10-15

Completion Date

2028-06-30

Last Updated

2025-11-03

Healthy Volunteers

No

Interventions

BEHAVIORAL

Noise canceling earplugs

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

BEHAVIORAL

Usual care

No behavioral changes to limit noise exposure

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States