Voice Analysis Technology for Heart Attack Recovery

Overseen By Diana Albers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Antidepressants

Disqualifiers: Cardiac transplant, Substance use, 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: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a smartphone app that analyzes voice for signs of anxiety and depression can aid recovery after a heart attack when used with regular cardiac rehabilitation. Participants will be divided into two groups: one will use the Ellipsis Health Voice Application alongside their rehab, while the other will follow standard rehab procedures without the app. Ideal candidates for this trial have recently left the hospital after a heart attack, are about to start a cardiac rehab program, own a smartphone, and feel comfortable using a new app. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery methods for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are actively treated for anxiety or depression with medication or therapy.

What prior data suggests that this voice analysis technology is safe for heart attack recovery?

Research shows that the Ellipsis Health Voice Application is designed to be safe and easy to use. Although specific safety data from clinical trials is not available, the app uses voice analysis to monitor mental health, which is generally safe and low risk. The company's focus on testing and improving speech technology demonstrates a commitment to safety and effectiveness. Users have shared positive feedback, and since the app is already available to the public, it likely meets basic safety standards. Overall, the technology appears well-received, with no major problems reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Voice Analysis Technology for Heart Attack Recovery because it introduces a novel way to support recovery using a voice analysis smartphone app. Unlike standard cardiac rehabilitation, which focuses on physical exercises and medical supervision, this app analyzes patients' voices to monitor their emotional and psychological well-being. By integrating voice analysis with traditional rehabilitation, it offers a more holistic approach to recovery, aiming to address both physical and mental health needs. This innovative method could enhance patient engagement and adherence to rehabilitation programs, potentially leading to better overall outcomes.

What evidence suggests that this voice analysis app is effective for heart attack recovery?

Research shows that the Ellipsis Health Voice Application can detect anxiety and depression by analyzing a person's voice. A study published in JMIR AI found that this app uses artificial intelligence to accurately identify signs of depression in healthcare settings. This technology could help manage mental health by monitoring symptoms remotely, enabling healthcare providers to offer timely support. In this trial, some participants will use the app alongside cardiac rehabilitation to improve recovery for heart attack patients by addressing both mental health and physical recovery. Although the app appears promising, further research is needed to understand its full impact on heart attack recovery. ^{1 2 4 6 7}

Who Is on the Research Team?

Amir Lerman, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for heart attack survivors who own a smartphone, can use an app, and speak English. They must be diagnosed with myocardial infarction (MI) and starting cardiac rehab within 4 weeks of hospital discharge. It's not for pregnant individuals or those actively treated for anxiety or depression, nor patients with cardiac transplants, active substance use, neurocognitive disorders, psychosis, or mania.

Inclusion Criteria

Owns a smartphone

Willing to download and use a smartphone app

I am enrolled in a heart rehab program starting within 3 months after leaving the hospital.

Exclusion Criteria

Neurocognitive disorder

Active psychosis

Active suicidality

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 12 weeks of cardiac rehabilitation, with one group using a voice analysis smartphone app to detect anxiety and depression

12 weeks

Follow-up

Participants are monitored for changes in health behaviors, quality of life, depressive symptoms, anxiety symptoms, and perceived stress

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ellipsis Health Voice Application

Trial Overview The study tests if a voice analysis app on smartphones can help detect and manage depression and anxiety when used alongside traditional cardiac rehabilitation programs to improve patient outcomes compared to just the rehabilitation program alone.

How Is the Trial Designed?

Group I: Cardiac rehabilitation plus voice analysis Experimental Treatment 1 Intervention

Subjects will complete 12 weeks of cardiac rehabilitation as per clinical care and utilize a voice analysis smartphone app.

Group II: Cardiac rehabilitation only Active Control 1 Intervention

Subjects will complete 12 weeks of cardiac rehabilitation as per clinical care.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

The use of interactive voice response (IVR) technology significantly improved medication compliance and reduced adverse events in post-cardiac surgery patients, with a relative risk of 0.60 for the composite outcome of compliance and adverse events.

Patients who received IVR follow-up showed a remarkable reduction in medication non-compliance (relative risk of 0.34), and 93% of participants preferred this method of follow-up over no follow-up, indicating high acceptance of the technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using technology to create a medication safety net for cardiac surgery patients: a nurse-led randomized control trial. Sherrard, H., Struthers, C., Kearns, SA., et al.[2009]

The Avatar application significantly improved knowledge, attitudes, and beliefs about Acute Coronary Syndrome (ACS) among 70 patients over a 6-month period, with notable differences in symptom knowledge and healthcare utilization compared to usual care.

Participants using the Avatar app were more likely to recognize symptoms and seek help, with 33.33% using an ambulance compared to 18.18% in the usual care group, indicating the app's effectiveness in enhancing confidence in responding to ACS symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an Avatar application for teaching heart attack recognition and response: A pragmatic randomized control trial. Tongpeth, J., Du, H., Barry, T., et al.[2020]

The Q-Voz application, designed for voice therapy, received positive feedback from seven speech therapists, who found it useful for helping patients with dysphonia improve their voice-related habits.

All evaluators agreed that the app could facilitate easier changes in voice behavior for patients, suggesting it can be an effective auxiliary tool in voice rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prototype app for voice therapy: a peer review. Lavaissiéri, P., Melo, PE.[2022]

Vox4Health, an m-health system, demonstrated a detection accuracy of 72.6% for voice disorders using acoustic measures, with jitter providing the highest sensitivity at 96%.

When enhanced with machine learning techniques, Vox4Health improved its accuracy to 77.4%, indicating its potential as a reliable screening tool for voice disorders in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voice Disorder Detection via an m-Health System: Design and Results of a Clinical Study to Evaluate Vox4Health. Cesari, U., De Pietro, G., Marciano, E., et al.[2022]

Seven out of eight studies reviewed found that smartphone voice analyzer applications can provide assessments comparable to traditional techniques for managing voice disorders.

Despite promising results, there are still challenges to address, such as inconsistencies in voice parameters, types of voice pathologies tested, and variations in smartphone software and microphone quality before these applications can be widely adopted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Current State and Future Possibilities of Mobile Phone "Voice Analyser" Applications, in Relation to Otorhinolaryngology. Munnings, AJ.[2021]

Mobile health (mHealth) is significantly advancing cardiovascular care through innovative strategies like SMS for smoking cessation and apps for monitoring health, showing promise in prevention and rehabilitation.

Despite the potential of mHealth, many apps lack regulation and evidence-based support, highlighting the need for robust systems to ensure safety and effectiveness in delivering healthcare services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth in Cardiovascular Health Care. Chow, CK., Ariyarathna, N., Islam, SM., et al.[2022]

A smartphone app has been developed to monitor patients' heart conditions, providing real-time data and alerts for potential risks.

Nurses have reported positive feedback on the app's effectiveness in enhancing patient care and early detection of heart-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New app could help cardiac patients manage condition and avert a crisis. Longhurst, C.[2017]

Mobile applications and wearable sensors are increasingly being used to manage cardiovascular risk factors and improve treatment adherence, but their long-term benefits still need to be proven.

Daily home monitoring of pulmonary artery pressures using wireless sensors has been linked to a significant reduction in hospital readmissions for heart failure, highlighting the potential of technology to enhance patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A sneak peek into digital innovations and wearable sensors for cardiac monitoring. Michard, F.[2018]

A smartphone-based ECG analyzer (QCG™) demonstrated superior performance in detecting ST-elevation myocardial infarction (STEMI) compared to human experts, with an AUC-ROC of 0.919 versus 0.856 for all clinicians.

The AI system's accuracy remained consistent across various image acquisition conditions, indicating its robustness and reliability in diagnosing STEMI regardless of how the ECG images were captured.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artificial intelligence versus physicians on interpretation of printed ECG images: Diagnostic performance of ST-elevation myocardial infarction on electrocardiography. Choi, YJ., Park, MJ., Ko, Y., et al.[2022]

Mobile health (mHealth) tools, such as interactive voice response and text messaging, have been shown to effectively improve lifestyle behaviors and management of cardiovascular diseases, particularly in low- and middle-income countries, based on a comprehensive review of studies since 2004.

These interventions can enhance preventive care by addressing key risk factors like weight, smoking, and physical activity, and have also demonstrated benefits in managing hypertension and improving medication adherence, suggesting they are a feasible option for improving health outcomes globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Devices as Tools for Worldwide Cardiovascular Risk Reduction and Disease Management. Piette, JD., List, J., Rana, GK., et al.[2023]

Citations

1. ellipsishealth.com ellipsishealth.com/

Homepage - Ellipsis Emotionally intelligent AI Care Management to elevate your clinical operations. Immediately expands capacity; Reduces costs; Supercharges existing workflows ...

2. ellipsishealth.com ellipsishealth.com/research/how-ellipsis-healths-clinically-validated-vocal-biomarker-technology-is-breaking-down-barriers-in-the-mental-health-sphere/

How Ellipsis Health's clinically validated vocal biomarker ... Ellipsis Health leads the field in vocal biomarker technology due to our pioneering research into natural language processing (NLP) and ...

3. apps.apple.com apps.apple.com/us/app/rising-higher/id1501156781

Rising Higher on the App Store Ellipsis Health is improving health one voice at a time. Using artificial intelligence, we have pioneered the first vital sign for behavioral health based ...

4. hit.show hit.show/ellipsis-health-announces-rising-higher-new-voice-based-app-to-help-healthcare-providers-identify-and-manage-behavioral-health-at-scale/

Ellipsis Health Announces Rising Higher, New Voice-Based ... Rising Higher is a clinical decision support tool that enables healthcare providers and payors to remotely monitor symptoms in high-risk patient populations.

5. ellipsishealth.com ellipsishealth.com/research/breakthrough-study-validates-voice-ai-for-real-world-depression-detection-in-healthcare/

Breakthrough study validates voice AI for real-world ... A groundbreaking study from Highmark Health and Ellipsis Health, published in JMIR AI, demonstrates that artificial intelligence can accurately detect and ...

6. ellipsishealth.com ellipsishealth.com/insights/

Ellipsis insights We are committed to leading the industry in clinical and speech technology research, establishing best practices, and contributing to the impact of voice.

7. apps.apple.com apps.apple.com/dk/app/rising-higher/id1501156781

Rising Higher on the App Store Ellipsis Health is improving health one voice at a time. Using artificial intelligence, we have pioneered the first vital sign for ...