Recruiting

Earplugs

Sponsor:

Massachusetts General Hospital

Code:

NCT07148817

Conditions

Cardiometabolic Diseases

Noise Exposure

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Noise canceling earplugs

Usual care

Study Details

Brief 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.

Conditions

Cardiometabolic Diseases

Noise Exposure

Study ID

NCT07148817

Start date

Oct 15, 2025

Status verified date

Oct, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

26 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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

Usual care

No behavioral changes to limit noise exposure

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Michael Osborne, MD

mosborne@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 3, 2025

Last verified

Oct, 2025

Keywords

  • Transportation Noise
  • Cardiometabolic Diseases
  • Earplugs

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-11-03.