Audio Data Collection for Identification and Classification of Coughing

Completed

• Conditions: COVID-19; Common Cold; Respiratory Tract Infections; Coronavirus Infections; Hay Fever; Healthy; Asthma; Chronic Obstructive Pulmonary Disease; Influenza

• Registration Number: NCT04326309
• Lead Sponsor: HealthMode Inc.

Brief Summary

An open access study that will define and collect digital measures of coughing in multiple populations and public spaces using various means of audio data collection.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-25
• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-30
• Primary Completion: 2022-01-24
• Study Completion: 2022-01-24
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-22
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

Cohort 1, 3, 4 and 5:

• Females and males over 18 years old
• Willing to share demographic data with the sponsor of the study
• Willing to follow app use instructions during the course of the study
• Willing to complete survey instruments as described in study procedures
• Willing to provide electronic informed consent
• Able to read and understand the English language well enough to complete electronic informed consent

Cohort 2:

Any person present in the vicinity of a HealthMode Cough Monitoring Device

Exclusion Criteria

No exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dataset size	14 days	Size of collected audio dataset measured as number of collected cough sounds, targeting ≥10,000 identified coughs.

Secondary Outcome Measures

Name	Time	Method
Cough sound identification	14 days	Identification of cough sounds by the existing mathematical model with ≥ 99% specificity and ≥ 60% sensitivity
Improvement of the existing model	14 days	Increase in the sensitivity of the mathematical model to cough sounds to ≥ 70% while retaining the specificity of ≥ 99%
Evaluate the usability of the application	14 days	Determination of the level of acceptance and satisfaction of the solution by patients by means of a Standard Usability Questionnaire to provide feedback. The score ranges from 10 to 50, higher score indicating a better usability.

Trial Locations

Locations (1)

Virtual Facility; 🇺🇸 Bronx, New York, United States