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Clinical Trials/NCT06566911
NCT06566911
Recruiting
Not Applicable

A Pilot Study on AI-Based Voice Analysis for Monitoring Patients Hospitalized With Acute Decompensated Heart Failure

Noah Labs2 sites in 2 countries70 target enrollmentJanuary 24, 2024
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Noah Labs
Enrollment
70
Locations
2
Primary Endpoint
Change in vocal characteristics from admission to discharge and their correlation with heart failure severity markers.
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 24, 2024
End Date
September 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Noah Labs
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in vocal characteristics from admission to discharge and their correlation with heart failure severity markers.

Time Frame: 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).

Study Sites (2)

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