COVID-19NCT04326309
Audio Data Collection for Identification and Classification of Coughing
An observational study of COVID-19 and Coronavirus Infections, run by HealthMode Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Coronavirus Infections, Hay Fever
- How many people
- 336 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2020to 24 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- No exclusion criteria
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- COVID-19, Coronavirus Infections, Hay Fever, Asthma, Chronic Obstructive Pulmonary Disease, Influenza
- Medical subject headings
- COVID-19, Coronavirus Infections, Rhinitis, Allergic, Seasonal, Asthma, Pulmonary Disease, Chronic Obstructive, Influenza, Human, Common Cold, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Dataset size
Size of collected audio dataset measured as number of collected cough sounds, targeting ≥10,000 identified coughs.
Measured: 14 days
Secondary outcomes (3)
Cough sound identification
Identification of cough sounds by the existing mathematical model with ≥ 99% specificity and ≥ 60% sensitivity
Measured: 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%
Measured: 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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start25 Mar 2020
- Primary completion24 Jan 2022
- Study completion24 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthMode Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326309
- Sponsor's protocol ID
- HM070102
- Status last verified
- Apr 2022
- First submitted
- 26 Mar 2020
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audio Data Collection for Identification and Classification of Coughing
- ClinicalTrials.gov ID
- NCT04326309
- Acronym / sponsor ID
- HM070102
- Conditions
- COVID-19, Coronavirus Infections, Hay Fever, Asthma, Chronic Obstructive Pulmonary Disease, Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- HealthMode Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 24 Jan 2022 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- No exclusion criteria
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dataset size
Time frame: 14 days
Size of collected audio dataset measured as number of collected cough sounds, targeting ≥10,000 identified coughs.
3 secondary outcomes
Cough sound identification
Time frame: 14 days
Improvement of the existing model
Time frame: 14 days
Evaluate the usability of the application
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Coronavirus Infections, run by HealthMode Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dataset size (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.