Clinical trial NCT05042063: Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease
Official title: Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cough
COPD
GERD
Asthma
Tuberculosis
Non-Tuberculous Mycobacterial Pneumonia
COVID-19 Pneumonia
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
name: Hyfe Inc
First posted: 2021-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For the main study group, the population are patients with respiratory disease treated in the Clínica Universidad de Navarra (Pamplona and Madrid campuses).

Since the validation sub-study 1 only requires elicited sounds, a group of participants from a previous study will be directly invited to participate. For the validation sub-study 2, participants will include both, inpatients admitted to the Clínica Universidad de Navarra and presenting cough, and healthy individuals directly invited to participate by the study team.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between subjective perception of cough and objective frequency
timeFrame: 6 months.
Secondary outcomes:
measure: Sensitivity of the system discriminating coughs
timeFrame: 6 months.
measure: Specificity of the system discriminating coughs
timeFrame: 6 months.
measure: Positive predictive value (PPV) of the system discriminating coughs
timeFrame: 6 months.
measure: Negative predictive value (NPV) of the system discriminating coughs
timeFrame: 6 months.
measure: Construction of an annotated cough dataset
timeFrame: 5 years.
measure: Sensitivity of the system differentiating coughs caused by different conditions
timeFrame: 5 years.
measure: Specificity of the system differentiating coughs caused by different conditions
timeFrame: 5 years.
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
Study officials:
affiliation: Clinica Universidad de Navarra
name: Carlos Chaccour, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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