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
|Condition or disease||Intervention/treatment|
|Covid19 Cough||Device: Hyfe cough tracker|
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|
|Estimated Enrollment :||300 participants|
|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|
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.
- 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.
- 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.
- 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?
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
|Contact: Carlos Chaccourfirstname.lastname@example.org|
|Universidad de Navarra||Recruiting|
|Pamplona, Navarra, Spain, 31009|
|Contact: Carlos Chaccour +34666293112 email@example.com|
|Sub-Investigator: Juan Gabaldón|
|Principal Investigator:||Carlos Chaccour||Clínica Universidad de Navarra|