RecruitingNCT07443670

Voice Analysis to Detect Pulmonary Arterial Pressure Changes in Heart Failure

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

Sponsor

Noah Labs

Enrollment

60 participants

Start Date

Dec 12, 2024

Study Type

OBSERVATIONAL

Conditions

Heart Failure

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria9

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

Interventions

OTHERDaily 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.