Voice Analysis to Detect Pulmonary Arterial Pressure Changes in Heart Failure (VAPP-HF)

February 24, 2026 updated by: Noah Labs

Voice Analysis Using Artificial Intelligence to Detect Changes in Pulmonary Arterial Pressure in Patients With Heart Failure and an Implanted Pressure Sensor

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Implanted PA pressure sensors enable early detection of heart failure decompensation but are costly and invasive. Fluid retention in heart failure may affect the vocal apparatus, producing measurable voice changes that could serve as a non-invasive alternative for monitoring pulmonary congestion.

Participants record daily voice samples consisting of sustained vowel sounds and a standardized reading passage via the Noah Labs mobile app. PA pressure readings are collected daily per standard care. Voice recordings and clinical data are analyzed retrospectively using classical machine learning and deep learning approaches. No additional clinical visits are required.

Study Type

Observational

Enrollment (Estimated)

60

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

  • Germany
      • Frankfurt, Germany, 60590
        • Completed
        • University Hospital Frankfurt, Dept. of Cardiology and Angiology
    • State of Berlin
      • Berlin, State of Berlin, Germany, 12683
        • Completed
        • BG Klinikum Unfallkrankenhaus Berlin, Dept. of Cardiology
  • United States
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco (UCSF)
        • Contact:

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

No

Sampling Method

Non-Probability Sample

Study Population

Adults aged 18 years or older with chronic heart failure and a successfully implanted pulmonary arterial pressure sensor, monitored at participating centers in Germany and the United States.

Description

Inclusion Criteria:

  • Age 18 years or older
  • Successful implantation of a PA pressure sensor and monitored by a participating study center
  • Willingness to record a short predefined text daily for 3 months using a smartphone or tablet
  • Ability to comfortably read aloud the study passage in English or German
  • Written informed consent obtained

Exclusion Criteria:

  • Pregnant, breastfeeding, or unwilling to practice birth control during participation
  • Condition that in the opinion of the investigator would compromise patient safety or data quality
  • Pathological voice changes due to surgery or injury
  • Planned invasive cardiac procedures during the study period
  • COPD requiring home oxygen therapy
  • Chronic kidney disease requiring dialysis
  • Cognitive dysfunction limiting ability to perform daily voice recording
  • Inability to read English or German
  • Physical inability to use the recording device

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
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.
Other: Daily Voice Recording
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of AI Voice Analysis in Detecting PA Pressure Changes
Time Frame: 12 weeks
Sensitivity and specificity of the AI-based voice analysis algorithm in detecting pulmonary arterial pressure changes at pre-specified thresholds.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
orrelation Between Voice Predictions and Clinical Events
Time Frame: 12 weeks
Correlation between voice biomarker predictions and clinical outcomes including hospitalizations and diuretic adjustments.
12 weeks
Predictive Accuracy of Machine Learning Models
Time Frame: 12 weeks
Predictive accuracy of machine learning models for early detection of signs of heart failure decompensation, reported as area under the ROC curve.
12 weeks
Adherence to Daily Voice Recording
Time Frame: 12 weeks
Percentage of days with at least one transmitted voice recording over the 12-week study period.
12 weeks

Collaborators and Investigators

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

Sponsor

Noah Labs

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)

December 12, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3

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.

Clinical Trials on Heart Failure

Clinical Trials on Daily Voice Recording

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe