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Digital Acoustic Surveillance for Early Detection of Respiratory Disease Outbreaks

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ClinicalTrials.gov Identifier: NCT04762693
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : February 24, 2021
Sponsor:
Collaborator:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Covid19 Cough Device: Hyfe cough tracker

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Digital Acoustic Surveillance for Early Detection of Respiratory Disease Outbreaks: An Exploratory Observational Study in Navarra, Spain
Actual Study Start Date : November 11, 2020
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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?



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04762693


Contacts
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Contact: Carlos Chaccour +34948255400 cchaccour@unav.es

Locations
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Spain
Universidad de Navarra Recruiting
Pamplona, Navarra, Spain, 31009
Contact: Carlos Chaccour    +34666293112    cchaccour@unav.es   
Sub-Investigator: Juan Gabaldón         
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Investigators
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Principal Investigator: Carlos Chaccour Clínica Universidad de Navarra
Publications:

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Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT04762693    
Other Study ID Numbers: DASRD
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
chronic cough
Covid19
Acoustic surveillance
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases