Voice Analysis to Detect Pulmonary Arterial Pressure Changes in Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Daily Voice Recording.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Voice Analysis Using Artificial Intelligence to Detect Changes in Pulmonary Arterial Pressure in Patients With Heart Failure and an Implanted Pressure Sensor
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- Sensitivity of AI Voice Analysis in Detecting PA Pressure Changes [Time frame: 12 weeks]
Secondary outcome measures (3)
- orrelation Between Voice Predictions and Clinical Events [Time frame: 12 weeks]
- Predictive Accuracy of Machine Learning Models [Time frame: 12 weeks]
- Adherence to Daily Voice Recording [Time frame: 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 2 centers
- BG Klinikum Unfallkrankenhaus Berlin, Dept. of Cardiology — Berlin
- University Hospital Frankfurt, Dept. of Cardiology and Angiology — Frankfurt
United States · 1 center
- University of California, San Francisco (UCSF) — San Francisco
Identifiers
NCT: NCT07443670 · 3