Earplugs to reduce noise-related heart and metabolic risk
Impact of Personal Mitigation on Mechanisms Linking Transportation Noise Exposure to Cardiometabolic Disease
This study will test whether wearing noise-canceling earplugs reduces stress-related brain activity and other heart-risk markers in adults with atherosclerosis or common cardiovascular risk factors who are bothered by transportation noise.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07148817 on ClinicalTrials.gov |
What this trial studies
This randomized interventional study compares nightly use of noise-canceling earplugs versus usual care in adults with stable atherosclerosis or at least one typical cardiovascular risk factor who report bothersome transportation noise or live in areas with high noise. Investigators will use FDG PET imaging to measure stress-associated neural activity (eg, amygdala-to-cortex metabolic patterns) and will collect autonomic, inflammatory, and vascular biomarkers before and after the intervention. Participants taking excluded cardiovascular medications or with neurologic/psychiatric contraindications will be screened out to ensure safety and interpretability. The goal is to determine whether simple personal noise mitigation lowers upstream stress signaling and downstream markers of cardiovascular risk.
Who should consider this trial
Good fit: Adults who are annoyed by transportation noise or live in areas with average residential noise greater than 45 dBA and who have stable atherosclerosis or at least one typical cardiovascular risk factor are the intended participants.
Not a fit: Patients already using personal noise mitigation or those excluded for safety or confounding reasons (for example recent stroke, certain cardiovascular medications, pregnancy, claustrophobia, or active severe psychiatric/substance use disorders) are unlikely to receive benefit or be eligible.
Why it matters
Potential benefit: If successful, a low-cost intervention like earplugs could lower stress signaling and early markers of cardiovascular risk, potentially reducing long-term heart disease risk.
How similar studies have performed: Previous research has linked transportation noise to stress signaling and used FDG PET to measure stress-associated neural activity, but testing whether earplugs reduce those neural and cardiovascular markers is a relatively novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Michael Osborne, MD — Massachusetts General Hospital
- Study coordinator: Alula Assefa
- Email: aassefa2@mgh.harvard.edu
- Phone: 617-726-2393
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.