Digital Acoustic Surveillance for Early Detection of Respiratory Disease Outbreaks

Completed

• Conditions: Cough; Covid19
• Interventions: Device: Hyfe cough tracker

• Registration Number: NCT04762693
• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Brief Summary

An observational study to evaluate the accuracy of a digital cough monitoring tool to reflect the incidence of COVID-19 and other respiratory infections at the community level in the city of Pamplona, Spain.

Detailed Description

This is a single-center prospective observational study that pretends to evaluate the accuracy of an acoustic surveillance mobile app to detect individual episodes of cough among a monitored population, as well as the barriers and facilitators that might affect uptake of similar platforms at a population level.

The app in question, Hyfe cough tracker, runs in the background of smartphones, and records short snippets (\<0.5 seconds) of explosive, putative cough sounds. These are then classified as cough or non-cough, using a convolutional neural network (CNN) model, and matched to GPS and time data collected by the smartphone.

The night-time cough of participants will be monitored for a 30-day period, and their clinical records will be reviewed regularly, specifically looking for diagnoses of cough-producing diseases, and with special emphasis on COVID-19.

Cough data will be used to create a heatmap of cough density and geographic distribution. Aggregated cough registries will be used to calculate the coughs per person-hour registered in the cohort. These data will be used to carry out an ARIMA analysis on three parallel time series at the community level: The incidence of respiratory disease in the monitored cohort, in the entire study area (including the Universidad de Navarra, and the neighbouring Cendea de Cizur), and the cough frequency per monitored hours.

Changes in cough frequency will also be compared to other environmental variables such as temperature and pollution level registered in the study area.

Study Timeline

• Study Start: 2020-11-11
• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-21
• Primary Completion: 2022-05-23
• Study Completion: 2022-05-24
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 930

Inclusion Criteria

• Be aged 13 or above,
• Own and regularly use a smartphone able to run the cough-tracking system,
• Be willing to install and regularly use it,
• Be current residents of Navarra, and
• Have an active relationship with the university (having interest in the study, or being a student or worker, be a patient with a cough-related diagnosis at the Clínica Universidad de Navarra, or Cizur's health centre).

Exclusion Criteria

• Inability to accept the privacy policy and terms of use of the cough-tracking system.
• Inability to grant access to medical records.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cough monitoring	Hyfe cough tracker	All enrolled participants will be asked to install the acoustic surveillance software in their smartphones and use it to record night-time coughs for a minimum 30-day period.

Primary Outcome Measures

Name	Time	Method
Correlation between registered coughs per person-hour and incidence of respiratory diseases	1 year	The investigators will run an ARIMA analysis with three parallel time series: aggregated incidence of respiratory diseases in the observed cohort, in the entire study area, and aggregated cough data.

Secondary Outcome Measures

Name	Time	Method
Uptake of the surveillance system	1 year	The investigators will calculate the proportion of the total reached, eligible population that installs the app and regularly uses it in the requested way.
Barriers and facilitators affecting uptake of the surveillance system	1 month	A sub-sample of 25 participants will be randomly recruited for focus group discussions. In the focus groups, researchers will ask participants the following general questions: (1) What do you like about the app, (2) what do you think of this app relative to other health apps, (3) what doesn't work well, (4) what keeps you committed (or not) to using the app, (5) what do you think the purpose of the app is, (6) do you think the app has commercial value, and (7) what advice do you have for the developers?

Trial Locations

Locations (1)

Universidad de Navarra; 🇪🇸 Pamplona, Navarra, Spain