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Clinical Trials/NCT04762693
NCT04762693
Completed
Not Applicable

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

Clinica Universidad de Navarra, Universidad de Navarra1 site in 1 country930 target enrollmentNovember 11, 2020
ConditionsCovid19Cough

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Enrollment
930
Locations
1
Primary Endpoint
Correlation between registered coughs per person-hour and incidence of respiratory diseases
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 11, 2020
End Date
May 24, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Uptake of the surveillance system(1 year)
  • Barriers and facilitators affecting uptake of the surveillance system(1 month)

Study Sites (1)

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