A neurobiological mechanism linking transportation noise to cardiovascular disease in humans.
Michael T Osborne, Azar Radfar, Malek Z O Hassan...
https://pubmed.ncbi.nlm.nih.gov/31769799Actively Recruiting
Led by Massachusetts General Hospital · Updated on 2025-11-03
26
Participants Needed
1
Research Sites
12 weeks
Total Duration
M
Massachusetts General Hospital
Lead Sponsor
A
American Heart Association
Collaborating Sponsor
This research aims to understand how transportation noise from cars, planes, and trains impacts heart and metabolic health. Noise exposure causes stress by triggering changes in the brain and activating the "fight or flight" response, which can lead to inflammation and blood vessel disease. Because noise often occurs alongside other stressors like air pollution and low income, and few laws or medical treatments address noise, this study focuses on whether using earplugs can reduce noise-related effects on heart disease risk. The study will include 26 adults with stable atherosclerosis or risk factors such as hypertension, diabetes, smoking, or high cholesterol, who are exposed to high levels of noise or feel annoyed by it. Participants will be randomly assigned to use noise-cancelling earplugs during sleep and rest for 6 months or to continue usual care without noise mitigation. At the start and end of the 6-month period, brain and blood vessel imaging, along with tests of stress, inflammation, and autonomic function, will be performed to assess changes. Participants will have evaluations including advanced PET/MRI scans of the brain and aorta, assessments of heart rate variability, blood pressure, blood tests, and surveys about stress and lifestyle. The study will monitor earplug use and measure outcomes such as stress-associated neural activity and arterial inflammation. Results will help clarify how noise affects the body and whether personal noise protection can reduce the risk of cardiovascular disease over the 6-month study period.
CONDITIONS
Impact of Earplugs on Mechanisms of Noise-Related Cardiovascular Disease
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants are randomized to use noise canceling earplugs or continue usual care to assess effects on stress and cardiovascular risk factors.
1 baseline visit and 1 follow-up visit
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
A
Alula Assefa
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Michael T Osborne, Azar Radfar, Malek Z O Hassan...
https://pubmed.ncbi.nlm.nih.gov/31769799Michael T Osborne, Nicki Naddaf, Shady Abohashem...
https://pubmed.ncbi.nlm.nih.gov/34183223Mette Sørensen, Göran Pershagen, Jesse Daniel Thacher...
https://pubmed.ncbi.nlm.nih.gov/38142584