Cardiometabolic Diseases, Noise Exposure
Conditions
Keywords
Transportation Noise, Cardiometabolic Diseases, Earplugs
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 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.
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 accounts for the loss of more than one million healthy life years per year in Europe. Noise exposure leads to activation of the stress response and nocturnal exposure may be more dangerous. The pathologic mechanisms linking noise to cardiovascular disease have recently been shown to involve changes in the metabolic activity of stress responsive brain regions (specifically the ratio of activity in the amygdala to that of the cortex or stress-associated neural activity, SNA) and fluorodeoxyglucose positron emission tomography, FDG PET) and autonomic dysfunction. These changes lead to stress hormone release, inflammation, vascular dysfunction, oxidative stress, increased cardiovascular risk factors, and, ultimately, atherosclerosis. However, there are few laws that restrict noise and it is not addressed in routine medical care. Further, as cities and industries grow, noise exposure continues to increase. Moreover, noise exposure often occurs coincidentally with other psychosocial and environmental stressors, such as high air pollution and low income. Yet, there is little research on noise, and it is not known if personal noise mitigation attenuates the stress response and downstream markers of cardiovascular risk. The investigators will leverage will use advanced FDG PET/magnetic resonance imaging to test if noise canceling earplugs improve stress symptoms and reduce SNA, arterial inflammation, and autonomic and inflammatory intermediaries. The study will assess whether earplug use will decrease SNA and arterial inflammation by attenuating autonomic and inflammatory intermediaries. The investigators will recruit 26 people with cardiovascular risk with high noise exposure or annoyance for this pilot study. At baseline, subjects will have FDG PET/MRI of the brain and aorta and will have assessments of stress, inflammation, and autonomic function. They will be randomized to use earplugs or control. After 6 months, the baseline visit will be repeated. This study will clarify how noise impacts the body and whether its adverse effects can be reduced. It may also identify novel treatments to prevent heart disease in people exposed to noise. By testing if the adverse effects of noise can be mitigated with earplugs, this study takes a necessary step towards reducing noise-related cardiovascular disease.
Interventions
BEHAVIORALNoise canceling earplugs
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
BEHAVIORALUsual care
No behavioral changes to limit noise exposure
Sponsors
American Heart Association
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stress-Associated Neural Activity | Baseline and 6 months | Measured on FDG-PET as the ratio of metabolic activity of the amygdala to that of the cortex. |
| Arterial inflammation | Baseline and 6 months | Measured as radiotracer uptake in the wall of the thoracic aorta relative to background venous blood uptake via FDG-PET imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Earplug use | 6 months | Time log of earplug use during the study intervention |
| Stress surveys | Baseline and 6 months | Self-reported assessments of perceived stress, noise annoyance, and symptoms of depression and anxiety |
| HOMA-IR | Baseline and 6 months | Measure of insulin sensitivity performed by blood sample |
| Leukopoiesis | Baseline and 6 months | Measured as bone marrow activity via FDG-PET imaging |
| Blood pressure | Baseline and 6 months | Systolic and diastolic pressure |
| MRI based arterial plaque components (such as necrotic tissue and hemorrhage) | Baseline and 6 months | MRI measurements of atherosclerotic plaque components including necrotic tissue and hemorrhage using black-blood imaging techniques |
| Heart rate variability | Baseline and 6 months | Calculated from the average resting heart rate variability collected at baseline and post-treatment visits |
| MRI based brain structure assessments of volume | Baseline and 6 months | Structural assessment of brain centers to assess volume of neural centers involved in the stress response |
| MRI based brain connectivity (by measuring changes in blood flow across networks of neural centers at rest and with an emotional task) | Baseline and 6 months | Connectivity assessment using mapping on functional MRI at baseline and in response to emotional faces of neural centers involved in the stress response to determine the interplay between neural centers before and after therapy by measuring alterations in blood oxygen content under various conditions in different parts of the brain |
| MRI based brain activation (via measuring blood flow in important neural centers at rest and with an emotional task using functional MRI) | Baseline and 6 months | Activation assessment using functional MRI at both rest and in response to emotional faces of neural centers involved in the stress response before and after therapy by measuring blood flow under various conditions to different parts of the brain |
| Axonal integrity of resting neural connections between brain centers using MRI | Baseline and 6 months | Measurement of axonal integrity using diffusion tensor imaging on MRI to determine the strength connections between important brain centers and neural networks related to stress perception before and after earplugs |
| MRI based brain structure assessments of density | Baseline and 6 months | Structural assessment of brain centers to evaluate the density of neural centers involved in the stress response |
| MRI based arterial wall thickness | Baseline and 6 months | Measurements of wall thickness as an assessment of atherosclerotic plaque |
| Lifestyle factors | Baseline and 6 months | Self-reported survey results on diet, sleep, and exercise |
Countries
United States
Contacts
Primary ContactAlula Assefa
Outcome results
None listed