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Audio Data Collection for Identification and Classification of Coughing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04326309
Recruitment Status : Recruiting
First Posted : March 30, 2020
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
COVID-19 Coronavirus Infections Hay Fever Asthma Chronic Obstructive Pulmonary Disease Influenza Common Cold Respiratory Tract Infections Healthy

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Audio Data Collection for Identification and Classification of Coughing
Actual Study Start Date : March 25, 2020
Estimated Primary Completion Date : September 25, 2022
Estimated Study Completion Date : September 25, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Group/Cohort
Cohort 1
Individual Application Downloaders
Cohort 2
Public Space and Vehicle Data Capture



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Criteria

Inclusion Criteria:

Cohort 1:

  • 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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04326309


Contacts
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Contact: Daniel R Karlin, MD, MA +1 (201) 212-6643

Locations
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United States, New York
Virtual Facility Recruiting
Bronx, New York, United States, 10461
Contact: Daniel R Karlin, MD, MA         
Sponsors and Collaborators
HealthMode Inc.
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Responsible Party: HealthMode Inc.
ClinicalTrials.gov Identifier: NCT04326309    
Other Study ID Numbers: HM070102
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Coronavirus Infections
Severe Acute Respiratory Syndrome
Common Cold
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Picornaviridae Infections