Voice Analysis Using Artificial Intelligence to Detect Changes in Pulmonary Arterial Pressure in Patients With Heart Failure and an Implanted Pressure Sensor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Sensitivity of AI Voice Analysis in Detecting PA Pressure Changes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Daily Voice Recording (Other)
结局指标
主要结局
Sensitivity of AI Voice Analysis in Detecting PA Pressure Changes
时间窗: 12 weeks
Sensitivity and specificity of the AI-based voice analysis algorithm in detecting pulmonary arterial pressure changes at pre-specified thresholds.
次要结局
- orrelation Between Voice Predictions and Clinical Events(12 weeks)
- Predictive Accuracy of Machine Learning Models(12 weeks)
- Adherence to Daily Voice Recording(12 weeks)