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NCT07148817 · ClinicalTrials.gov registry record · NA
Impact of Earplugs on Mechanisms of Noise-Related Cardiovascular Disease
A NA study of Cardiometabolic Diseases and Noise Exposure, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT07148817 is a NA study of Cardiometabolic Diseases and Noise Exposure that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 26 participants, below the 176-participant average among 3 other Cardiometabolic Diseases trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07148817, a NA study of Cardiometabolic Diseases and Noise Exposure, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 176-participant average among 3 other Cardiometabolic Diseases trials with a reported enrollment target (85% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
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.
NCT07148817 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
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.
What interventions are being tested in trial NCT07148817?
The interventions under investigation include: Usual care (BEHAVIORAL), Noise canceling earplugs (BEHAVIORAL).
Who is sponsoring clinical trial NCT07148817?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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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