Status:
RECRUITING
Impact of Earplugs on Mechanisms of Noise-Related Cardiovascular Disease
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
American Heart Association
Conditions:
Cardiometabolic Diseases
Noise Exposure
Eligibility:
All Genders
18-65 years
Phase:
NA
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 mor...
Detailed Description
Transportation noise is a pervasive exposure in modern life that has been associated with cardiovascular and metabolic disease. Almost 30% of Americans are exposed to harmful levels of noise and noise...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT07148817
Start Date
October 15 2025
End Date
June 30 2028
Last Update
November 3 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114