Digital Acoustic Surveillance for Early Detection of Respiratory Disease Outbreaks

NCT04762693 | Completed

• 1 other identifier: DASRD
• Study Type: observational
• Target: 930
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Cough

Keywords

chronic cough; Covid19; Acoustic surveillance

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (2)

• Uptake of the surveillance system

  1 year

• Barriers and facilitators affecting uptake of the surveillance system

  1 month

Study Arms (1)

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

Interventions

Hyfe cough tracker DEVICE

A mobile app that runs in the background of smartphones and detects putative cough sounds.

Cough monitoring

Eligibility Criteria

• Age: 13 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator

Study Sites (1)

Universidad de Navarra

Pamplona, Navarre, 31009, Spain

Location

Related Publications (13)

• Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

  PMID: 31986264 BACKGROUND

• Kim GU, Kim MJ, Ra SH, Lee J, Bae S, Jung J, Kim SH. Clinical characteristics of asymptomatic and symptomatic patients with mild COVID-19. Clin Microbiol Infect. 2020 Jul;26(7):948.e1-948.e3. doi: 10.1016/j.cmi.2020.04.040. Epub 2020 May 1.

  PMID: 32360780 BACKGROUND

• Peeling RW, Wedderburn CJ, Garcia PJ, Boeras D, Fongwen N, Nkengasong J, Sall A, Tanuri A, Heymann DL. Serology testing in the COVID-19 pandemic response. Lancet Infect Dis. 2020 Sep;20(9):e245-e249. doi: 10.1016/S1473-3099(20)30517-X. Epub 2020 Jul 17.

  PMID: 32687805 BACKGROUND

• Chowdhury R, Luhar S, Khan N, Choudhury SR, Matin I, Franco OH. Long-term strategies to control COVID-19 in low and middle-income countries: an options overview of community-based, non-pharmacological interventions. Eur J Epidemiol. 2020 Aug;35(8):743-748. doi: 10.1007/s10654-020-00660-1. Epub 2020 Jul 13.

  PMID: 32656618 BACKGROUND

• Rasheed J, Jamil A, Hameed AA, Aftab U, Aftab J, Shah SA, Draheim D. A survey on artificial intelligence approaches in supporting frontline workers and decision makers for the COVID-19 pandemic. Chaos Solitons Fractals. 2020 Dec;141:110337. doi: 10.1016/j.chaos.2020.110337. Epub 2020 Oct 10.

  PMID: 33071481 BACKGROUND

• Porter P, Abeyratne U, Swarnkar V, Tan J, Ng TW, Brisbane JM, Speldewinde D, Choveaux J, Sharan R, Kosasih K, Della P. A prospective multicentre study testing the diagnostic accuracy of an automated cough sound centred analytic system for the identification of common respiratory disorders in children. Respir Res. 2019 Jun 6;20(1):81. doi: 10.1186/s12931-019-1046-6.

  PMID: 31167662 BACKGROUND

• Sharan RV, Abeyratne UR, Swarnkar VR, Claxton S, Hukins C, Porter P. Predicting spirometry readings using cough sound features and regression. Physiol Meas. 2018 Sep 5;39(9):095001. doi: 10.1088/1361-6579/aad948.

  PMID: 30091716 BACKGROUND

• Santillana M, Nguyen AT, Louie T, Zink A, Gray J, Sung I, Brownstein JS. Cloud-based Electronic Health Records for Real-time, Region-specific Influenza Surveillance. Sci Rep. 2016 May 11;6:25732. doi: 10.1038/srep25732.

  PMID: 27165494 BACKGROUND

• Mukundarajan H, Hol FJH, Castillo EA, Newby C, Prakash M. Using mobile phones as acoustic sensors for high-throughput mosquito surveillance. Elife. 2017 Oct 31;6:e27854. doi: 10.7554/eLife.27854.

  PMID: 29087296 BACKGROUND

• Naseem M, Akhund R, Arshad H, Ibrahim MT. Exploring the Potential of Artificial Intelligence and Machine Learning to Combat COVID-19 and Existing Opportunities for LMIC: A Scoping Review. J Prim Care Community Health. 2020 Jan-Dec;11:2150132720963634. doi: 10.1177/2150132720963634.

  PMID: 32996368 BACKGROUND

• Liss DT, Serrano E, Wakeman J, Nowicki C, Buchanan DR, Cesan A, Brown T. "The Doctor Needs to Know": Acceptability of Smartphone Location Tracking for Care Coordination. JMIR Mhealth Uhealth. 2018 May 4;6(5):e112. doi: 10.2196/mhealth.9726.

  PMID: 29728349 BACKGROUND

• Galvosas M, Gabaldon-Figueira JC, Keen EM, Orrillo V, Blavia I, Chaccour J, Small PM, Gimenez G, Rudd M, Grandjean Lapierre S, Chaccour C. Performance evaluation of the smartphone-based AI cough monitoring app - Hyfe Cough Tracker against solicited respiratory sounds. F1000Res. 2023 Jun 9;11:730. doi: 10.12688/f1000research.122597.2. eCollection 2022.

  PMID: 39931660 DERIVED

• Gabaldon-Figueira JC, Brew J, Dore DH, Umashankar N, Chaccour J, Orrillo V, Tsang LY, Blavia I, Fernandez-Montero A, Bartolome J, Grandjean Lapierre S, Chaccour C. Digital acoustic surveillance for early detection of respiratory disease outbreaks in Spain: a protocol for an observational study. BMJ Open. 2021 Jul 2;11(7):e051278. doi: 10.1136/bmjopen-2021-051278.

  PMID: 34215614 DERIVED

MeSH Terms

Conditions

COVID-19; Cough; Chronic Cough

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlos Chaccour

  Clínica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: November 11, 2020
• Primary Completion: May 23, 2022
• Study Completion: May 24, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

ES (1)