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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04326309
Recruitment Status : Completed
First Posted : March 30, 2020
Last Update Posted : April 29, 2022
Sponsor:
Information provided by (Responsible Party):
HealthMode Inc.

Tracking Information
First Submitted Date March 26, 2020
First Posted Date March 30, 2020
Last Update Posted Date April 29, 2022
Actual Study Start Date March 25, 2020
Actual Primary Completion Date January 24, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 26, 2020)		 Dataset size [ Time Frame: 14 days ]
Size of collected audio dataset measured as number of collected cough sounds, targeting ≥10,000 identified coughs.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 26, 2020)
  • Cough sound identification [ Time Frame: 14 days ]
    Identification of cough sounds by the existing mathematical model with ≥ 99% specificity and ≥ 60% sensitivity
  • 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%
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Audio Data Collection for Identification and Classification of Coughing
Official Title Audio Data Collection for Identification and Classification of Coughing
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)
Condition
  • COVID-19
  • Coronavirus Infections
  • Hay Fever
  • Asthma
  • Chronic Obstructive Pulmonary Disease
  • Influenza
  • Common Cold
  • Respiratory Tract Infections
  • Healthy
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 22, 2022)		 336
Original Estimated Enrollment
 (submitted: March 26, 2020)		 1000
Actual Study Completion Date January 24, 2022
Actual Primary Completion Date January 24, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

-
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04326309
Other Study ID Numbers HM070102
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party HealthMode Inc.
Original Responsible Party Same as current
Current Study Sponsor HealthMode Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account HealthMode Inc.
Verification Date April 2022