Impact of Earplugs on Mechanisms of Noise-Related Cardiovascular Disease

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07148817
Status
Recruiting
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Conditions

  • Cardiometabolic Diseases
  • Noise Exposure

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Noise canceling earplugs — BEHAVIORAL
    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
  • Usual care — BEHAVIORAL
    No behavioral changes to limit noise exposure

Study Details

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.

Key Dates

Start date
Oct 15, 2025
Status verified
Oct 2025
Primary completion
Apr 1, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
26 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Earplug use
    Individuals assigned to this group will use earplugs to attenuate noise \<45 dB during sleep and rest during the 6 month study period
  • Placebo Comparator: Control
    Individuals assigned to this group will not attempt noise mitigation during sleep and rest during the 6 month study period

Primary Outcome Measure

Stress-Associated Neural Activity [ Time Frame: Baseline and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Michael Osborne, MD
[email protected]

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By research site
Massachusetts General Hospital· Boston, MA

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