Impact of Earplugs on Mechanisms of Noise-Related Cardiovascular Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Noise canceling earplugs

    Behavioral

    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

    Behavioral

    No behavioral changes to limit noise exposure

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: Earplug useActive comparator 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Stress-Associated Neural Activity

Measured on FDG-PET as the ratio of metabolic activity of the amygdala to that of the cortex.

Time frame
Baseline and 6 months
2

Arterial inflammation

Measured as radiotracer uptake in the wall of the thoracic aorta relative to background venous blood uptake via FDG-PET imaging

Time frame
Baseline and 6 months

Secondary outcomes

1

Heart rate variability

Calculated from the average resting heart rate variability collected at baseline and post-treatment visits

Time frame
Baseline and 6 months
2

Lifestyle factors

Self-reported survey results on diet, sleep, and exercise

Time frame
Baseline and 6 months
3

Earplug use

Time log of earplug use during the study intervention

Time frame
6 months
4

Stress surveys

Self-reported assessments of perceived stress, noise annoyance, and symptoms of depression and anxiety

Time frame
Baseline and 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

American Heart Association

Collaborator