Voice Analysis to Detect Pulmonary Arterial Pressure Changes in Heart Failure

Conditions

• Heart Failure

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Daily Voice Recording — OTHER
  Patients record daily voice samples (sustained vowels and a standardized reading passage) using the Noah Labs mobile app. PA pressure readings are collected daily per standard care using the implanted sensor. Voice recordings are analyzed retrospectively using machine learning algorithms after study completion.

Study Details

VAPP-HF is a prospective, multi-center, observational study assessing whether daily voice recordings analyzed by a machine learning algorithm can detect changes in pulmonary arterial (PA) pressure in heart failure patients with implanted PA pressure sensors (e.g., CardioMEMS, Cordella). Patients across three sites in Germany and the United States provide daily voice recordings via a mobile app for 12 weeks while continuing standard PA pressure monitoring and heart failure care. Voice data is analyzed retrospectively after study completion; no clinical decisions are based on voice analysis during the study. The primary endpoint is the sensitivity and specificity of the AI-based voice analysis in detecting PA pressure changes at defined thresholds.

Key Dates

Start date

Dec 12, 2024

Status verified

Feb 2026

Primary completion

May 31, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

60 participants (estimated)

Arms

• Arm: Groups and Interventions Use this module to add a description of each group or cohort in the study a
  Heart failure patients with implanted PA pressure sensors providing daily voice recordings via a mobile app for 12 weeks while continuing standard PA pressure monitoring and heart failure care. Voice data is analyzed retrospectively; no clinical decisions are based on voice analysis during the study.

Primary Outcome Measure

Sensitivity of AI Voice Analysis in Detecting PA Pressure Changes [ Time Frame: 12 weeks ]

Central Contacts

• Leonhard Riehle, MD
  +491715547970
  [email protected]

Locations (1)

Find similar trials in San Francisco, CA

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