AI Evaluation of COVID-19 Sounds (AI-EChOS)

NCT05115097 | Unknown

• 1 other identifier: AI-EChOS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators record sounds of voice, breaths and cough of subjects who tested positive for COVID19. The investigators then feed these sounds into an artificial intelligence and see if it can learn to recognise features to make COVID19 diagnosis from these sounds in order to avoid to use swabs to test the general population.

Conditions

COVID-19; COVID-19 Respiratory Infection; Cough; Breathing Sound; Breathing, Mouth

Keywords

COVID-19; artificial intelligence; machine learning; sound; cough; breath; voice; diagnosis; automation; AI; ML; pneumonia; symptoms; airways; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Accuracy evaluation

  The investigators will evaluate the accuracy of the ML algorithm in terms of sensitivity and specificity and ROC-AUC

  September 2022-December 2022

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants from the general population meeting the inclusion criteria will be included in three cohorts: 1. SARS-CoV-2 positive 2. SARS-CoV-2 negative but with respiratory disease 3. Healthy volunteers

You may qualify if:

• Adults who tested positive for SARS-CoV-2 currently admitted to hospital at the study site
• Adults who tested negative for SARS-CoV-2 and are admitted for any respiratory condition (eg COPD or asthma flare-up, pneumonia..)
• Healthy volunteers

You may not qualify if:

• Patients under the age of 18.
• Patients unable to read in Italian.
• Patients unable to give informed consent to participate.
• Patients requiring life support (including, but not limited to, mechanical cardiac support, ventilation, etc.)
• Patients who are pregnant

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

San Raffaele Hospital and Scientific Institute

Milan, (Mi), 20132, Italy

RECRUITING

MeSH Terms

Conditions

COVID-19; Cough; Respiratory Sounds; Mouth Breathing; Disease; Pneumonia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; 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; Pathologic Processes

Study Officials

• Marco Montagna, Medicine

  Vita-Salute San Raffaele University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Montagna, Medicine

CONTACT

+390226439744; montagna.marco@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Head of Endocrino-Metabolic and Diabetologic Medicine

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 10, 2021
• Study Start: September 20, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

IT (1)