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Clinical Trial Summary

This study pretends to evaluate the potential use of Hyfe Cough Tracker (Hyfe) to screen for, diagnose, and support the clinical management of patients with respiratory diseases, while enriching a dataset of disease-specific annotated coughs, for further refinement of similar systems.


Clinical Trial Description

This is an observational study that will take place in the two campuses of the Clínica Universidad de Navarra, located in Pamplona and Madrid (Spain). An Artificial-Intelligence system (AI) that detects and records explosive putative cough sounds and identifies human cough based on acoustic characteristics will be used to automatically monitor cough. Potential participants either attending the outpatient clinic or hospitalised with a complaint of cough will be invited by their treating physician, or a member of the research team, and included in the study by part of the research team. A researcher will instruct participants on how to install and use Hyfe Cough Tracker in their smartphones. Participants will be monitored for 30 days (outpatients) or until discharged from the hospital (inpatients). Participants will be asked to complete a daily, online, standardised 100 mm visual analogue scale (VAS) to register changes in the subjective intensity of their cough, while using Hyfe to objectively monitor changes in its frequency. In parallel, a dataset of annotated cough sounds will be constructed and retrospectively used to assess differences in acoustic patterns of cough, and to evaluate the performance of the system detecting them. A first subgroup of participants will be recruited outside the clinical setting and asked to provide a series of elicited sounds, including coughs, which will then be used to determine the system's performance accurately discriminating coughs from non-cough sounds, and compared to trained human listeners. A second subgroup of participants will be will be instructed to use Hyfe, and the related Hyfe Air wearable device continuously for a period between 6 and 24 hours, while they record themselves using a MP3 recorder connected to a lapel microphone. This group will be used to evaluate the performance of Hyfe and Hyfe Air in a real-life setting, with spontaneous coughs. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05042063
Study type Observational
Source Clinica Universidad de Navarra, Universidad de Navarra
Contact Carlos Chaccour, MD, PhD
Phone +34948255400
Email cchaccour@unav.es
Status Recruiting
Phase
Start date September 15, 2021
Completion date September 15, 2026

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