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

Trial Summary

What is the purpose of this trial?

This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system.

Will I have to stop taking my current medications?

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

How does the MindMics Earbud treatment for heart conditions differ from other treatments?

The MindMics Earbud treatment is unique because it likely involves a noninvasive method to monitor or influence heart conditions through the ear, which is different from traditional treatments that may involve medication or invasive procedures. This approach could be similar to noninvasive techniques used in ear-related conditions, like the tympanic membrane displacement test, which measures pressure changes. ^{1 2 3 4 5}

Research Team

Sanjeev Bhavnani, MD

Principal Investigator

Scripps Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Noninvasive perilymphatic pressure measurement in patients with Ménière's disease and patients with idiopathic sudden sensorineural hearing loss. [2014]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Intratympanic steroids for inner ear disorders: a review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The tympanic membrane displacement test and tinnitus: preliminary report on clinical observations, applications, and implications. [2018]

4. United States 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. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

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