NCT04326309

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
336

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2022

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

1.8 years

First QC Date

March 26, 2020

Last Update Submit

April 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dataset size

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

    14 days

Secondary Outcomes (3)

  • Cough sound identification

    14 days

  • Improvement of the existing model

    14 days

  • Evaluate the usability of the application

    14 days

Study Arms (5)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virtual Facility

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

COVID-19Coronavirus InfectionsRhinitis, Allergic, SeasonalAsthmaPulmonary Disease, Chronic ObstructiveInfluenza, HumanCommon ColdRespiratory Tract Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRhinitis, AllergicRhinitisNose DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesBronchial DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOrthomyxoviridae InfectionsPicornaviridae Infections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2020

First Posted

March 30, 2020

Study Start

March 25, 2020

Primary Completion

January 24, 2022

Study Completion

January 24, 2022

Last Updated

April 29, 2022

Record last verified: 2022-04

Locations