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临床试验/NCT04762693
NCT04762693已完成不适用

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

Clinica Universidad de Navarra, Universidad de Navarra1 个研究点 分布在 1 个国家目标入组 930 人开始时间: 2020年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
930
试验地点
1
主要终点
Correlation between registered coughs per person-hour and incidence of respiratory diseases

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
13 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

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

结局指标

主要结局

Correlation between registered coughs per person-hour and incidence of respiratory diseases

时间窗: 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.

次要结局

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

研究者

发起方
Clinica Universidad de Navarra, Universidad de Navarra
申办方类型
Other
责任方
Sponsor

研究点 (1)

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