Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 23-012146
About this 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. Electrocardiograms (ECGs) will be collected from those who choose to share and have an Apple Watch version 4 or greater with ECG capability, not SE. iOS users will have the option to submit activity data, clinical data, and sensor usage (ex: movement, ambient light sensors, optical and electrical data collected for heart rate detection and ECG). Your health, and wellness will be followed for up to 5- years or longer if you choose to remain in the study.
The Mayo Clinic CV Research study app will transmit your voice/speech data, Health app data, and Apple Watch ECGs collected as part of this research in a secure manner from your iOS smartphone and Apple Watch to Mayo Clinic. Android users at this time will only be able to transmit voice/speech data. Your data will be stored in a secure research database. Your speech sample will not be part of your medical record. If you decide to send ECGs recorded with your Apple watch version 4 or greater, your provider can review your ECGs in the Cardiology tab under AI-ECG Dashboard in your Mayo Clinic medical record, although you will need to notify your care provider of participation.
To access the CV Research app you can go directly to your Apple app store or Play Store for Android and search for: Mayo Clinic CV Research app. After you download the Mayo Clinic CV Research app, sign into the app using your patient services username and password. Please contact the study team if you have any questions: Voicestudy@mayo.edu. Thank you for participating in the Heart and Voice study.
Paul Friedman, MD, Brad Leibovich, MD, Zachi Attia Ph.D., and Jennifer Dugan
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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:
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 11/21/23. Questions regarding updates should be directed to the study team contact.