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Impact of Earplugs on Mechanisms of Noise-Related Cardiovascular Disease
NCT07148817 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Usual care
- BEHAVIORAL Noise canceling earplugs
Study Locations (1)
Massachusetts
- Massachusetts General Hospital — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2025-10-15 |
| Est. Completion | 2028-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07148817
The ClinicalTrials.gov registry entry for NCT07148817 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 1,948 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Cardiometabolic Diseases appearing as the primary indexed condition, and to 2 interventions — of which Usual care is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07148817 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07148817 about?
NCT07148817 is a clinical study titled "Impact of Earplugs on Mechanisms of Noise-Related Cardiovascular Disease". 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 danger...
What is the current status of trial NCT07148817?
This trial is currently recruiting. It is a NA study. The enrollment target is 26 participants. The study started on 2025-10-15. Estimated completion is 2028-06-30.
What conditions does trial NCT07148817 study?
This clinical trial studies the following conditions: Cardiometabolic Diseases, Noise Exposure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07148817?
The interventions under investigation include: Usual care (BEHAVIORAL), Noise canceling earplugs (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07148817?
This trial is sponsored by Massachusetts General Hospital, which has 1,948 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07148817 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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