Earplugs to reduce noise-related heart and metabolic risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Differentiating heart disease in autoimmune vs. type 2 diabetes

  This study tests whether adult-onset autoimmune diabetes (AID/LADA) and type 2 diabetes (T2D) differ in how diabetic heart disease develops, using advanced heart imaging in people with AID, T2D, and healthy controls.

  Recruiting University of Roma La Sapienza · Rome, Roma · NCT07911007

• Cardio-Metabolic Clinic care for adults with type 2 diabetes and cardiovascular disease

  This trial tests whether a specialized Cardio-Metabolic Clinic can improve heart function and overall health for adults with type 2 diabetes and cardiovascular disease compared with usual care.

  Recruiting Odense University Hospital · Svendborg · NCT07878325

• A safe test of a new medicine for healthy adults

  This study tests a new medicine called NNC0705-0002 in healthy adults to see if it is safe and how it behaves in the body.

  Recruiting Phase 1 Novo Nordisk A/S · Groningen · NCT07797855

• Nutrition Counselling for people with diabetes and high blood pressure

  Aimed at adults with both type 2 diabetes and hypertension, this study tests whether structured nutrition counselling helps people stick to better diets and improve health-related quality of life.

  Recruiting Bahir Dar University · Dessie · NCT07712900

• Maternal insulin and fat metabolism in pregnancies at risk for preeclampsia and gestational diabetes

  This project will try to see if insulin resistance and how the body burns fats early in pregnancy predict later preeclampsia or gestational diabetes in people at higher risk.

  Recruiting University of Tennessee Graduate School of Medicine · Knoxville, Tennessee · NCT07565727

• Multilevel program to reduce noise exposure and protect hearing for farmworkers

  A program with training and gear will be tested to see if it lowers workers' noise exposure and helps prevent hearing loss among farmworkers.

  Recruiting San Diego State University · San Diego, California · NCT07554378

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.