Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07148817

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

Led by Massachusetts General Hospital · Updated on 2025-11-03

26

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

A

American Heart Association

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to understand how transportation noise from cars, planes, and trains impacts heart and metabolic health. Noise exposure causes stress by triggering changes in the brain and activating the "fight or flight" response, which can lead to inflammation and blood vessel disease. Because noise often occurs alongside other stressors like air pollution and low income, and few laws or medical treatments address noise, this study focuses on whether using earplugs can reduce noise-related effects on heart disease risk. The study will include 26 adults with stable atherosclerosis or risk factors such as hypertension, diabetes, smoking, or high cholesterol, who are exposed to high levels of noise or feel annoyed by it. Participants will be randomly assigned to use noise-cancelling earplugs during sleep and rest for 6 months or to continue usual care without noise mitigation. At the start and end of the 6-month period, brain and blood vessel imaging, along with tests of stress, inflammation, and autonomic function, will be performed to assess changes. Participants will have evaluations including advanced PET/MRI scans of the brain and aorta, assessments of heart rate variability, blood pressure, blood tests, and surveys about stress and lifestyle. The study will monitor earplug use and measure outcomes such as stress-associated neural activity and arterial inflammation. Results will help clarify how noise affects the body and whether personal noise protection can reduce the risk of cardiovascular disease over the 6-month study period.

CONDITIONS

Brief Title

Impact of Earplugs on Mechanisms of Noise-Related Cardiovascular Disease

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Feel annoyed by transportation noise or have high residential noise exposure (>45 dBA average over 24 hours)
  • Have stable atherosclerosis or at least one typical risk factor such as hypertension, diabetes, active smoking, or hyperlipidemia
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • History of stroke, brain surgery, or seizure
  • Use of certain cardiovascular medications (e.g., beta-blockers, high-intensity statins, PCSK-9 inhibitors)
  • Psychiatric or cardiovascular medication changes within 3 months (stable regimen allowed)
  • Unstable blood pressure or cardiac arrhythmia
  • Current use of personal noise mitigation or involvement in stress management program
  • Moderate to severe alcohol or substance use disorder
  • Current mania or psychosis
  • Weight over 300 lbs
  • Claustrophobia
  • Pregnancy
  • Metal implants
  • Uncontrolled high blood sugar (HgbA1c >7.5%)
  • Significant radiation exposure from research procedures in the past 12 months (>2 nuclear tests, CT scans, or fluoroscopic procedures)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months

Participants are randomized to use noise canceling earplugs or continue usual care to assess effects on stress and cardiovascular risk factors.

1 baseline visit and 1 follow-up visit

Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

A

Alula Assefa

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial