A Pilot Study on AI-Based Voice Analysis for Monitoring Patients Hospitalized With Acute Decompensated Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in vocal characteristics from admission to discharge and their correlation with heart failure severity markers.
研究概览
简要总结
This observational study involves ADHF patients at two sites in the United States and Germany. After informed consent and screening assessments, participants will perform daily voice recordings during their hospital stay, from admission until discharge. Alongside voice data, additional clinical information such as left ventricular ejection fraction, NTpro-BNP levels, and ECG-data will be collected for comprehensive analysis. The study's goal is to identify voice-based indicators of heart failure progression, with the potential to enhance remote monitoring and self-management strategies for heart failure patients.
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
- •Clinically diagnosed with Acutely Decompensated Heart Failure.
- •At least 18 years of age.
- •Exclusion criteria:
- •Disabling mental diseases (e.g., Alzheimer's disease)
- •Clinically diagnosed chronic obstructive pulmonary disease (COPD)
- •Treatment in ICU or IMU
- •Dialysis treatment
- •Previous operations on organs involved in generation of voice (vocal tract, vocal folds, etc.)
- •Neurodegenerative diseases
- •Pregnancy
- •Inability to provide consent
排除标准
- 未提供
结局指标
主要结局
Change in vocal characteristics from admission to discharge and their correlation with heart failure severity markers.
时间窗: Hospital stay
The primary endpoint is the change in vocal characteristics from admission to discharge, and its correlation with clinical markers of heart failure severity, such as weight change from admission to discharge, NTpro-BNP levels, ECG-parameters, and left ventricular ejection fraction (LVEF).
次要结局
未报告次要终点