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

University of Navarra

Status: Completed

Conditions: Non-Tuberculous Mycobacterial Pneumonia; COVID-19 Pneumonia; Asthma; Tuberculosis; Cough; GERD; COPD

Treatments: Device: Hyfe Air; Device: Hyfe Cough Tracker

Study type: Observational

Funder types: Other

Identifiers

NCT05042063

PI_2021/72

Details and patient eligibility

About

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.

Full 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.

Enrollment: 616 patients

Sex: All

Ages: 5 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

616 participants in 3 patient groups

Participants with cough as a symptom

Description:

This group will be composed of patients at the Clínica Universidad de Navarra that complain of having cough as a remarkable symptom.

Treatment:

Device: Hyfe Cough Tracker

Validation subgroup 1

Description:

This subgroup will be composed by both, patients belonging to the main study group, as well as voluntaries, who will be asked to provide a series of elicited cough and non-cough sounds for validation purposes.

Treatment:

Device: Hyfe Cough Tracker

Validation subgroup 2

Description:

This subgroup will be composed by inpatients admitted to the Clínica Universidad de Navarra with a diagnosis of respiratory disease, or presenting cough as a symptom, as well as healthy individuals. This group will be monitored with Hyfe Cough Tracker and Hyfe Air for a variable period of 6-24 hours, while they are recorded with a MP3 recorder connected to a lapel microphone.

Treatment:

Device: Hyfe Cough Tracker

Device: Hyfe Air