MindMics Earbud for Heart Conditions

Overseen By Carly Waldman, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Scripps Health

Disqualifiers: Carotid artery disease, Valvular disease, Implantable devices, Arrhythmia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special earbud, called MindMics, to determine if it can accurately monitor heart health without invasive procedures. It targets individuals with heart conditions such as coronary artery disease, severe aortic stenosis (narrowing of the heart valve), severe mitral regurgitation (leaking heart valve), pulmonary hypertension (high blood pressure in the lungs), and heart failure with reduced ejection fraction (a measure of heart pumping efficiency). Ideal participants have normal heart rhythms and good heart function but should not have devices like pacemakers or any hearing loss. The goal is to assess whether this earbud can help doctors track heart health in a simple, noninvasive way. As an unphased trial, this study offers a unique opportunity to contribute to innovative heart health monitoring technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the MindMics earbud is safe for detecting cardiovascular functions?

Research shows that the MindMics earbud, which uses special technology to monitor heart function, is generally safe for use. Previous studies have demonstrated that this device can assess heart health by detecting low-frequency vibrations in the ear. It has identified heart conditions like aortic stenosis, capturing important heart sounds without causing harm.

Available studies do not report negative effects related to the MindMics earbud, suggesting that users tolerate the device well. Since this study is in the "Not Applicable" phase, it likely focuses on proving accuracy and safety, rather than testing a new drug or invasive treatment. This usually means minimal risks are involved.

In summary, existing research indicates that the MindMics earbud is a safe option for those interested in participating in the trial, with no reported side effects from its use in previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MindMics earbud because it offers a non-invasive, easy-to-use way to monitor heart conditions. Unlike traditional methods that might require hospital visits or invasive procedures, this earbud can potentially provide continuous, real-time heart monitoring right from a patient's ear. This is particularly promising for conditions like coronary artery disease, severe aortic stenosis, and heart failure, where early detection and regular monitoring are crucial. By making heart monitoring more accessible and convenient, the MindMics earbud could lead to earlier interventions and better management of these conditions.

What evidence suggests that the MindMics earbud is effective for heart conditions?

This trial will evaluate the MindMics earbud, which uses infrasonic hemodynography (IH) to assess heart functions by detecting low-frequency vibrations from the body. Participants will be divided into different arms based on specific heart conditions, such as suspected coronary artery disease, severe aortic stenosis, severe mitral regurgitation, pulmonary hypertension, and heart failure with reduced ejection fraction.

Research has shown that this technology can effectively identify various heart conditions by detecting specific sound patterns linked to these issues. For coronary artery disease, MindMics matched its readings with standard medical tests like ECGs and echocardiograms. In cases of aortic stenosis, the earbuds identified the disease's unique heart murmur patterns before traditional methods. Early research also suggests they might help diagnose severe mitral regurgitation and pulmonary hypertension by analyzing heart rhythms and sounds. Although still under study, the earbuds show promise as a non-invasive way to monitor heart health. ^{1 2 4 6 7}

Who Is on the Research Team?

Sanjeev Bhavnani, MD

Principal Investigator

Scripps Health

Are You a Good Fit for This Trial?

This trial is for people with certain heart conditions like mitral valve regurgitation, various types of pulmonary hypertension, aortic valve stenosis, coronary artery disease, and heart failure. Participants should have a normal heartbeat rhythm and good left ventricle pumping function.

Inclusion Criteria

LV systolic function >53%

Normal Sinus Rhythm

Exclusion Criteria

Other implantable devices (pacemaker, ICD, CardioMems, TENS unit, continuous glucose monitors, etc)

Reduced Ejection Fraction (< 35%) other than Group 4

I have hearing loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Assessment

Participants undergo comprehensive echocardiogram, electrocardiogram, and cardiac catheterization while wearing an infrasonic earbud device

1-2 weeks

1 visit (in-person)

Data Analysis

Infrasonic and hemodynamic waveforms are analyzed using machine learning to correlate infrasound data with cardiovascular hemodynamics

Ongoing throughout the study

Follow-up

Participants are monitored for safety and effectiveness after diagnostic procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MindMics earbud

Trial Overview The study is testing the MindMics earbud's ability to noninvasively monitor the mechanical, electrical, and blood flow functions of the heart by comparing its accuracy with other diagnostic methods.

How Is the Trial Designed?

Group I: Suspected coronary artery disease Experimental Treatment 1 Intervention

Patients with plan to undergo elective left heart diagnostic catheterization for the assessment of coronary artery disease

Group II: Severe mitral regurgitation Experimental Treatment 1 Intervention

Patients with echocardiographic evidence of severe mitral regurgitation as defined by: * Central jet MR \>40% LA or holosystolic eccentric jet MR * Vena contracta ≥0.7 cm * Regurgitant volume ≥60 mL * Regurgitant fraction ≥50% * ERO ≥0.40 cm2 * Angiographic grade 3 to 4+

Group III: Severe aortic stenosis Experimental Treatment 1 Intervention

Patients with echocardiographic evidence of severe aortic stenosis as defined by: Aortic Vmax ≥4 m/s or mean ΔP ≥40 mmHg AVA ≤1.0 cm2

Group IV: Pulmonary Hypertension Experimental Treatment 1 Intervention

Patients with echocardiographic evidence of a mean pulmonary artery pressure (mPAP; supine and at rest) \>20mmHg

Group V: Heart Failure with Reduced EF <35% Experimental Treatment 1 Intervention

Patients with echocardiographic evidence of left ventricular ejection fraction of \< or = to 35%

Who Is Running the Clinical Trial?

Scripps Health

Lead Sponsor

Trials

59

Recruited

43,400+

Published Research Related to This Trial

In a study involving 77 patients with Ménière's disease, 28 with idiopathic sudden sensorineural hearing loss (ISSHL), and 50 normal hearing subjects, the noninvasive measurement of perilymphatic pressure using the MMS-10 Tympanic Displacement Analyser showed no significant differences between affected and normal ears.

The findings suggest that this measurement technique does not provide additional diagnostic value for confirming or rejecting diagnoses of Ménière's disease or ISSHL, indicating it may not be a useful tool in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive perilymphatic pressure measurement in patients with Ménière's disease and patients with idiopathic sudden sensorineural hearing loss. Rosingh, HJ., Albers, FW., Wit, HP.[2014]

A review of 38 clinical trials on intratympanic steroids (ITS) for treating inner ear disorders like Ménière's Disease and sudden sensorineural hearing loss revealed a lack of high-quality studies, with only 3 being double-blinded randomized trials.

The studies showed significant variability in steroid doses, treatment protocols, and definitions of disease, making it challenging to assess the true efficacy of ITS; thus, more rigorously designed research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intratympanic steroids for inner ear disorders: a review. Hu, A., Parnes, LS.[2022]

In a study of 104 patients with refractory high-frequency sudden sensorineural hearing loss, intratympanic dexamethasone (ITD) therapy showed better improvements in tinnitus compared to hyperbaric oxygen (HBO) therapy.

While both ITD and HBO therapies had similar overall effectiveness in hearing recovery, ITD therapy resulted in significant hearing gains at 8 kHz, indicating it may be a more effective option for certain aspects of hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of intratympanic dexamethasone therapy and hyperbaric oxygen therapy for the salvage treatment of refractory high-frequency sudden sensorineural hearing loss. Sun, H., Qiu, X., Hu, J., et al.[2018]

The tympanic membrane displacement test (TMDT) successfully identified abnormal intracranial pressure (ICP) in 10 out of 12 patients with severe subjective idiopathic tinnitus (SIT), suggesting a potential link between elevated ICP and tinnitus symptoms.

The TMDT demonstrated positive test-retest reliability and indicated that treatment targeting elevated ICP with medications like Diamox showed short-term benefits in some patients, highlighting the need for further investigation into the relationship between ICP and tinnitus management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The tympanic membrane displacement test and tinnitus: preliminary report on clinical observations, applications, and implications. Shulman, A., Goldstein, B., Marchbanks, RJ.[2018]

In a study involving 10 patients with intractable vertigo from Ménière's disease, the Meniett device effectively controlled vertigo in 9 out of 10 patients, with one patient experiencing a 50% reduction in symptoms over an average follow-up of 8 months.

The treatment also resulted in a statistically significant mean hearing gain of 6 dB, and no major complications were reported, indicating that the Meniett device is a safe option for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent pressure therapy of intractable Ménière's disease using the Meniett device: a preliminary report. Gates, GA., Green, JD.[2007]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9780339/

In-ear infrasonic hemodynography with a digital health ... In-ear infrasonic hemodynography (IH) can measure low-frequency vibrations (<20 Hz) created by vital organs as an acoustic waveform.

2. mindmics.com mindmics.com/research

Discover The Clinical Effectiveness of MindMics Evidence to date demonstrates clinical effectiveness of the MindMics technology, infrasonic hemodynography (IH), to monitor detailed cardiac function in a ...

3. nature.com nature.com/articles/s44325-025-00076-4

Non-invasive blood pressure monitoring with in-ear ... In this study, we investigate the correlation between IH waveforms and gold-standard techniques such as ECG, echocardiograms, and invasive ...

4. dicardiology.com dicardiology.com/content/mindmics-demonstrates-its-ear-infrasonic-earbud-technology-shows-promise-detection-aortic

MindMics Demonstrates Its In-ear Infrasonic Earbud ... MindMics' non-invasive infrasonic hemodynography (IH) technology can detect aortic stenosis by capturing in-ear acoustic vibrations throughout the cardiac ...

5. mindmics.com mindmics.com/press/heart-rhythm-society-2021

Heart Rhythm Society Meeting in Boston MindMics presented results from a clinical trial which show our in-ear technology can achieve cardiac arrhythmia assessment beyond ECG.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38204527/

A Novel Earbud Detects Aortic Stenosis Murmur Before ... Noninvasive infrasonic hemodynography using the MindMics earbuds captures low-frequency acoustic vibrations throughout the cardiac cycle.

7. citoday.com citoday.com/news/mindmics-infrasonic-hemodynography-technology-studied-for-as-detection-in-tavr-procedures

MindMics' Infrasonic Hemodynography Technology ... December 13, 2023—MindMics, Inc. reported results from a clinical study of its earbuds that use a new technology—noninvasive in-ear infras.