Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease

  • STATUS
    Recruiting
  • End date
    Sep 15, 2026
  • participants needed
    100
  • sponsor
    Clinica Universidad de Navarra, Universidad de Navarra
Updated on 17 November 2021
Accepts healthy volunteers

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.

Description

This is an observational study that will take place in the two campuses of the Clnica 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.

Details
Condition Chronic Obstructive Lung Disease, Cough, bronchial asthma, chronic obstructive pulmonary disease, Gastroesophageal Reflux, COVID 19 Pneumonia, COPD (Chronic Obstructive Pulmonary Disease), gastric reflux, esophageal reflux, Gastroesophageal Reflux Disease (GERD), COPD, gastroesophageal reflux disease, gerd, Reactive Airway Disease, Asthma, Allergies & Asthma, Tuberculosis, Chronic Cough, chronic obstructive pulmonary disease (copd), tb (tuberculosis), asthmatic, coughing, Non-Tuberculous Mycobacterial Pneumonia, Asthma (Pediatric), gastro-oesophageal reflux
Treatment Hyfe cough tracker, Hyfe Air
Clinical Study IdentifierNCT05042063
SponsorClinica Universidad de Navarra, Universidad de Navarra
Last Modified on17 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

For participants in the main study group
Outpatient or inpatients at the Clinical Universidad de Navarra with a complaint of cough
The patient or his/her legal representative, have given consent to participate in the study
For participants in the sub-study groups
Being 18 years or older
Providing consent for the sub-study

Exclusion Criteria

Inability to accept the privacy policy and terms of use of Hyfe
Lack of access to a Wi-Fi network at the site of residence (for the main study group)
Unwillingness to regularly use the cough-surveillance system throughout the monitoring period
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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