Voice-based Outcome Identification and Clinical Evaluation in Heart Failure

Condition(s) studied

Investigational drug(s) / intervention(s)

Daily Voice Recording: Patients use the mobile app daily to record voice samples and answer optional wellness and symptom-related questions. Voice recordings are analyzed by an algorithm, which extracts vocal biomechanical features. Results are not shared with clinicians and participants during the study and are analyzed retrospectively after study completion.

Study summary

VOICE-HF is a clinical study designed to evaluate the performance of a novel non-invasive software device (Noah Labs Vox) that uses vocal characteristics to estimate DHF risk and has strong potential for clinical success. This study will compare the performance of Noah Labs Vox with the contemporary performance of commonly used weight-based remote monitoring rules and applications to determine efficacy and safety.

Eligibility

Primary outcome measure(s)

• Performance Outcome Measure — From enrollment to the end of follow up of 6 months
  The co-primary objectives of the study are to evaluate the performance of the Noah Labs Vox algorithm in detecting heart failure decompensation events, in terms of sensitivity and unexplained alert rate.

Trial sites (1)

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