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OpenTrials
Completed

NCT Number: NCT04326309

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.

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Key information

Conditions

COVID-19 Asthma Bronchial Diseases Chronic Disease Chronic Obstructive Pulmonary Disease Common Cold Coronaviridae Infections Coronavirus Infections Disease Attributes Hay Fever Healthy Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Influenza Influenza, Human Lung Diseases Lung Diseases, Obstructive Nidovirales Infections Nose Diseases Orthomyxoviridae Infections Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Picornaviridae Infections Pneumonia Pneumonia, Viral Pulmonary Disease, Chronic Obstructive RNA Virus Infections Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Virtual Facility

The Bronx, New York, 10461, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Primary outcomes

  1. Dataset size

    Time frame: 14 days

    Size of collected audio dataset measured as number of collected cough sounds, targeting ≥10,000 identified coughs.

Secondary outcomes

  1. Cough sound identification

    Time frame: 14 days

    Identification of cough sounds by the existing mathematical model with ≥ 99% specificity and ≥ 60% sensitivity

  2. Improvement of the existing model

    Time frame: 14 days

    Increase in the sensitivity of the mathematical model to cough sounds to ≥ 70% while retaining the specificity of ≥ 99%

  3. Evaluate the usability of the application

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

HealthMode Inc.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 30, 2020
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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