Digital Acoustic Surveillance for Early Detection of Respiratory Disease Outbreaks

July 19, 2022 updated by: Clinica Universidad de Navarra, Universidad de Navarra

Digital Acoustic Surveillance for Early Detection of Respiratory Disease Outbreaks: An Exploratory Observational Study in Navarra, Spain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

930

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31009
        • Universidad de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited in the Cendea de Cizur, a municipality composed by a cluster of villages south of the city of Pamplona, and the neighbouring town of Cizur Mayor, in the Comunidad Foral de Navarra (Spain), as well as in the different campuses of the University of Navarra. The 4,000 people living in the Cendea de Cizur are served by a public health center which receives 45,000 outpatients visits per year. Of these, approximately 12% are associated with respiratory diseases. The University of Navarra has over 11,000 registered students, 900 professors and over 600 other employees. Both the Cendea de Cizur and the University are served by the Clínica Universidad de Navarra, the largest private health center in the region, which provides medical care to an estimated population of over 100,000 people.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cough monitoring
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.
Device: Hyfe cough tracker
A mobile app that runs in the background of smartphones and detects putative cough sounds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between registered coughs per person-hour and incidence of respiratory diseases
Time Frame: 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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of the surveillance system
Time Frame: 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.
1 year
Barriers and facilitators affecting uptake of the surveillance system
Time Frame: 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?
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2020

Primary Completion (Actual)

May 23, 2022

Study Completion (Actual)

May 24, 2022

Study Registration Dates

First Submitted

February 16, 2021

First Submitted That Met QC Criteria

February 16, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DASRD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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