Impact of Earplugs on Mechanisms of Noise-Related Cardiovascular Disease

NCT07148817 | Recruiting

• 2 other identifiers: 2025P00182125TPA1474746
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiometabolic Diseases; Noise Exposure

Keywords

Transportation Noise; Cardiometabolic Diseases; Earplugs

Outcome Measures

Primary Outcomes (2)

• Stress-Associated Neural Activity

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

  Baseline and 6 months

• Arterial inflammation

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

  Baseline and 6 months

Secondary Outcomes (14)

• Heart rate variability

  Baseline and 6 months

• Lifestyle factors

  Baseline and 6 months

• Earplug use

  6 months

• Stress surveys

  Baseline and 6 months

• HOMA-IR

  Baseline and 6 months

Study Arms (2)

Earplug use

ACTIVE COMPARATOR

Individuals assigned to this group will use earplugs to attenuate noise \<45 dB during sleep and rest during the 6 month study period

Behavioral: Noise canceling earplugs

Control

PLACEBO COMPARATOR

Individuals assigned to this group will not attempt noise mitigation during sleep and rest during the 6 month study period

Behavioral: Usual care

Interventions

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

Earplug use

Usual care BEHAVIORAL

No behavioral changes to limit noise exposure

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Heart Association: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (3)

• Osborne MT, Radfar A, Hassan MZO, Abohashem S, Oberfeld B, Patrich T, Tung B, Wang Y, Ishai A, Scott JA, Shin LM, Fayad ZA, Koenen KC, Rajagopalan S, Pitman RK, Tawakol A. A neurobiological mechanism linking transportation noise to cardiovascular disease in humans. Eur Heart J. 2020 Feb 1;41(6):772-782. doi: 10.1093/eurheartj/ehz820.

  PMID: 31769799 BACKGROUND

• Osborne MT, Naddaf N, Abohashem S, Radfar A, Ghoneem A, Dar T, Wang Y, Patrich T, Oberfeld B, Tung B, Pitman RK, Mehta NN, Shin LM, Lo J, Rajagopalan S, Koenen KC, Grinspoon SK, Fayad ZA, Tawakol A. A neurobiological link between transportation noise exposure and metabolic disease in humans. Psychoneuroendocrinology. 2021 Sep;131:105331. doi: 10.1016/j.psyneuen.2021.105331. Epub 2021 Jun 17.

  PMID: 34183223 BACKGROUND

• Sorensen M, Pershagen G, Thacher JD, Lanki T, Wicki B, Roosli M, Vienneau D, Cantuaria ML, Schmidt JH, Aasvang GM, Al-Kindi S, Osborne MT, Wenzel P, Sastre J, Fleming I, Schulz R, Hahad O, Kuntic M, Zielonka J, Sies H, Grune T, Frenis K, Munzel T, Daiber A. Health position paper and redox perspectives - Disease burden by transportation noise. Redox Biol. 2024 Feb;69:102995. doi: 10.1016/j.redox.2023.102995. Epub 2023 Dec 18.

  PMID: 38142584 BACKGROUND

Study Officials

• Michael Osborne, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alula Assefa

CONTACT

617-726-2393; aassefa2@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine and Cardiologist

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 29, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At the time of manuscript publication or study termination
• Access Criteria: These data will be available on an approved data site and will be accessible to the scientific community but will not include any identifying information

Locations

US (1)