Audio Data Collection for Identification and Classification of Coughing

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 336

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Virtual Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

US resident participants downloading the HealthMode Stool application from the Apple AppStore (Cohort 1) and persons in the vicinity of a HealthMode Cough Monitoring Device (Cohort 2)

Description

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

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Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Cohort 1; Individual Application Downloaders
Cohort 2; Public Space and Vehicle Data Capture
Cohort 3; Individuals dialing a voice-recording study phone number
Cohort 4; Individuals utilizing study website's audio recording functionality
Cohort 5; Individuals participating in Return-to-Work Project

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dataset size	Size of collected audio dataset measured as number of collected cough sounds, targeting ≥10,000 identified coughs.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cough sound identification	Identification of cough sounds by the existing mathematical model with ≥ 99% specificity and ≥ 60% sensitivity	14 days
Improvement of the existing model	Increase in the sensitivity of the mathematical model to cough sounds to ≥ 70% while retaining the specificity of ≥ 99%	14 days
Evaluate the usability of the application	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.	14 days

Collaborators and Investigators

• Sponsor: HealthMode Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2020
• Primary Completion (Actual): January 24, 2022
• Study Completion (Actual): January 24, 2022

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Disease Attributes; Otorhinolaryngologic Diseases; Picornaviridae Infections; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis, Allergic; Rhinitis; Coronavirus Infections; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Infections; Communicable Diseases; Rhinitis, Allergic, Seasonal; Respiratory Tract Infections; Common Cold
• Other Study ID Numbers: HM070102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No