NCT07148817

Impact of Earplugs on Mechanisms of Noise-Related Cardiovascular Disease

Recruiting now NA Last updated 3 November 2025

What this trial tests

NA trial testing Noise canceling earplugs in Cardiometabolic Diseases in 26 participants. Currently enrolling.

Timeline

15 October 2025

Primary endpoint
1 April 2028

30 June 2028

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	26
Start date	15 October 2025
Primary completion	1 April 2028
Estimated completion	30 June 2028
Sites	1 location across United States

Drugs / interventions tested

• Noise canceling earplugs
• Usual care

Conditions studied

• Cardiometabolic Diseases — all drugs for Cardiometabolic Diseases →
• Noise Exposure — all drugs for Noise Exposure →

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 65, any sex, with Cardiometabolic Diseases or Noise Exposure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.