Detection of Atrial Fibrillation Through Voice Signal Processing
NCT ID: NCT07212816
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
40 participants
OBSERVATIONAL
2025-10-15
2025-11-30
Brief Summary
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We are enrolling adults scheduled for a standard heart procedure called cardioversion, which is used to reset the heart to a normal rhythm. Each participant will provide voice recordings through three short phone calls: before cardioversion, just after the procedure, and at a follow-up visit. Results will be compared with standard heart rhythm tests (electrocardiograms or ECGs).
This research may lead to a simple, low-cost way to monitor heart rhythms remotely without requiring special devices.
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Detailed Description
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Participants will serve as their own controls. They will complete three structured voice recordings: pre-cardioversion, immediately after cardioversion, and at a follow-up visit (1 week to 1 month later). At each time point, ECG data will be collected as the reference standard. Voice samples will be captured through automated phone calls initiated via the Vital Audio platform, with each call lasting about one minute.
The software analyzes short vowel sounds in real time to extract heart rate, heart rate variability, and rhythm classification (regular vs. irregular). Data are stored securely, and results are available only to study staff. Patients and their providers will not receive study results directly.
The study is minimal risk, with no cost to participants. Compensation is provided for participation. While individuals may not personally benefit, the study aims to generate feasibility data on voice-based heart rhythm monitoring, potentially reducing reliance on costly consumer devices or frequent clinic visits. Findings will support future large-scale trials and may contribute to improved remote monitoring strategies for atrial fibrillation.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Atrial Fibrillation Patients Undergoing Cardioversion
Investigational, software-only device that acquires short voice samples during automated phone calls and analyzes cardiopulmonary signals to estimate heart rate (HR), heart-rate variability (HRV), and rhythm status (regular vs irregular). In this study, three calls are initiated via the Vital Audio web platform (pre-, post-cardioversion, and 1-month follow-up). Results are available only to study staff and are compared with ECG obtained at the same time points. The device is used for data collection/assessment only and does not guide clinical care. IDE: G230147.
Sauti
Investigational, software-only device that acquires short voice samples during automated phone calls and analyzes cardiopulmonary signals to estimate heart rate (HR), heart-rate variability (HRV), and rhythm status (regular vs irregular). In this study, three calls are initiated via the Vital Audio web platform (pre-, post-cardioversion, and 1-month follow-up). Results are available only to study staff and are compared with ECG obtained at the same time points. The device is used for data collection/assessment only and does not guide clinical care. IDE: G230147.
Interventions
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Sauti
Investigational, software-only device that acquires short voice samples during automated phone calls and analyzes cardiopulmonary signals to estimate heart rate (HR), heart-rate variability (HRV), and rhythm status (regular vs irregular). In this study, three calls are initiated via the Vital Audio web platform (pre-, post-cardioversion, and 1-month follow-up). Results are available only to study staff and are compared with ECG obtained at the same time points. The device is used for data collection/assessment only and does not guide clinical care. IDE: G230147.
Eligibility Criteria
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Inclusion Criteria
2. 3\. ≥ 18 years of age Written informed consent obtained from patient in English
Exclusion Criteria
1. History of a pacemaker
2. History of dysphasia or difficulty with word finding
3. History of vocal cord dysfunction
4. Patient with atrial flutter as presenting arrhythmia
5. Planned transesophageal echocardiogram (TEE) with cardioversion
18 Years
ALL
No
Sponsors
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Minneapolis Heart Institute Foundation
OTHER
Vital Audio Inc
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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Sonometrik-AFIB-01
Identifier Type: -
Identifier Source: org_study_id
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