A Study of Mayo Clinic CV Research Heart & Voice Study

November 3, 2025 updated by: Paul A. Friedman, Mayo Clinic

Evaluation of Voice and ECG Transmission and AI Models Using Voice, ECG and Health Data Collected Using a Mayo Clinic Center for Digital Health (CDH)-Developed App for a Repository: Mayo Clinic CV Research for Heart & Voice Study

The purpose of the study is to determine whether voice recordings acquired from patient-owned Android and Apple (iOS) smartphones can be used to monitor cardiovascular health. Voice signals will be processed to determine whether we can detect presence of cardiovascular disease and wellness, or if health risks exist.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
        • Principal Investigator:
          • Paul Friedman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who have the Mayo Clinic app and iOS 14 or Android smartphone (other types of smartphones will be added when functionality is added to the CDH app).

Description

Inclusion Criteria:

  • Adult patients using the Mayo patient iPhone app and iOS 14.0 or later (determined automatically via Mayo software) and Apple Watch v 4 or later (not SE), or if they have Android device for voice
  • Expressed interest in participation
  • Signed HIPPA authorization

Exclusion Criteria:

• Age under 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult patients using the Mayo patient iPhone app
Other: Voice Recording
Patients will record a 30-second to 2-minute video pronouncing vowel sounds or reading a short script. This will occur every 14 days for up to five years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Patients Who Recorded a Voice Sample
Time Frame: Baseline
The total number of patients who recorded a voice sample will be defined as those completing a 30-second to 2-minute video, pronouncing vowel sounds or reading a short script as prompted by the Mayo Clinic App.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Paul Friedman, M.D., Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2024

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

November 3, 2025

First Submitted That Met QC Criteria

November 3, 2025

First Posted (Estimated)

November 5, 2025

Study Record Updates

Last Update Posted (Estimated)

November 5, 2025

Last Update Submitted That Met QC Criteria

November 3, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-012146

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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