Noise Canceling Earplugs for Heart Health

Overseen By Alula Assefa

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Beta-blockers, High-intensity statins

Disqualifiers: Stroke, Seizure, Unstable blood pressure, others

Compensation: Varies

Number of Visits: 2

Duration: 6 months

26 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether noise-canceling earplugs can improve heart health by reducing stress from everyday noise, such as cars and planes. Researchers believe excessive noise can cause stress, affecting the brain and heart, and potentially leading to heart disease. Participants will either use earplugs or not for six months to determine if reduced noise exposure improves stress levels and heart health. The trial seeks individuals often bothered by noise or living in noisy areas who have heart disease risk factors, such as high blood pressure or diabetes. As an unphased trial, it offers participants the chance to contribute to groundbreaking research on noise reduction and heart health.

Do I need to stop taking my current medications for the trial?

The trial requires that you do not change your psychiatric or cardiovascular medications within 3 months before joining, meaning you should be on a stable regimen. However, if you are using certain heart medications like beta-blockers or high-intensity statins, you may not be eligible to participate.

What prior data suggests that noise canceling earplugs are safe for heart health?

In a previous study, most earplug users were younger women with lower risks of heart problems, suggesting safety for individuals with similar health profiles. Although the study did not focus on safety, it reported no major side effects. Earplugs are a simple and common tool to block noise, and most people use them without any problems. This trial aims to determine if using earplugs can lower stress and reduce the risk of heart disease. While specific safety data from this trial is not yet available, earplugs are widely used without significant issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using noise canceling earplugs for heart health because they offer a non-invasive, drug-free approach to potentially improving cardiovascular outcomes. Unlike medications or lifestyle changes typically used to manage heart health, these earplugs work by reducing noise exposure, which might lower stress and improve sleep quality. This method targets environmental factors that can affect heart health, offering a unique and simple intervention that could complement existing treatments like antihypertensive drugs or cholesterol-lowering medications.

What evidence suggests that noise canceling earplugs might be an effective treatment for heart health?

Research has shown that noise annoyance can be linked to heart problems, and using earplugs might help reduce these effects. In this trial, participants in the earplug group will use noise-canceling earplugs to reduce noise during sleep and rest. One study found that healthcare workers who used noise-canceling earbuds slept better. Another study demonstrated that reducing noise in hospitals improved heart rate and lowered stress in patients with heart issues. While more research is needed, these findings suggest that earplugs could benefit heart health by reducing stress and improving sleep. ^{1 4 5 6 7}

Who Is on the Research Team?

Michael Osborne, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for individuals at risk of heart disease who are frequently exposed to or annoyed by loud noises, such as traffic or industrial sounds. Participants should have characteristics of metabolic syndrome but cannot be part of the study if they have other conditions that might interfere with the results.

Inclusion Criteria

I can understand and sign the consent form.

I am bothered by loud noises where I live, as shown on the US DOT map.

I have stable atherosclerosis or at least one risk factor like high blood pressure, diabetes, I smoke, or have high cholesterol.

Exclusion Criteria

Weight >300 lbs.

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

My blood pressure and heart rhythm are stable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial imaging of the brain and blood vessels, assessments of stress, inflammation, and autonomic function

1 visit

1 visit (in-person)

Treatment

Participants are randomized to use earplugs or not for noise mitigation during sleep and rest

6 months

Follow-up

Repeat imaging and assessments to evaluate changes in stress symptoms and cardiovascular markers

1 visit

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Noise canceling earplugs

Trial Overview The study is testing whether using noise-canceling earplugs can reduce stress and prevent changes in the brain and blood vessels associated with cardiovascular disease. Participants will be randomly assigned to use earplugs or receive usual care without them over a six-month period.

How Is the Trial Designed?

Group I: Earplug use Active Control 1 Intervention

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

Group II: Control Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11930695/

Earplug use during sleep and its association ... Noise annoyance is linked to adverse cardiovascular outcomes, and earplug use may mitigate noise-related health effects. This study examines associations ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07148817

Impact of Earplugs on Mechanisms of Noise-Related ... 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 ...

3. healthline.com healthline.com/health/benefits-of-noise-cancelling-headphones

Health Benefits of Noise-Cancelling Headphones A small 2022 study with 26 health care workers found that wearing noise-canceling earbuds led to self-reported better sleep quality and ...

4. researchgate.net researchgate.net/publication/389653386_Earplug_use_during_sleep_and_its_association_with_cardiovascular_disease_-_Results_from_a_large_sample_of_the_general_population

(PDF) Earplug use during sleep and its association with ... Noise annoyance is linked to adverse cardiovascular outcomes, and earplug use may mitigate noise-related health effects. This study examines ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12459731/

Effect of Noise Reduction on Heart Rate Variability and Stress ... Conclusions: Noise reduction in hospital wards significantly improved HRV parameters and reduced stress markers in CAD patients. The ...

6. nature.com nature.com/articles/s41598-024-56250-8

Noise annoyance and cardiovascular disease risk Noise annoyance due to different sources was associated with prevalent CVD, whereas only weak associations with incident CVD were found.

7. theguardian.com theguardian.com/lifeandstyle/2023/aug/28/noise-cancelling-headphones-risks-concerns

The business of silence: is there a hidden cost to noise ... Google searches for “noise cancelling” and “earplugs ... Long-term noise pollution has been linked to increased risk of cardiovascular disease, ...