HealthyNCT03884582
Observational Study Using the CoVa Monitoring System 3
An observational study of Healthy, run by Baxter Healthcare Corporation at 1 site in United States.
Trial summary
Asthma is a complex and chronic inflammatory disorder which is associated with reversible airway obstruction and bronchial hyperresponsiveness. It is one of the most prevalent chronic diseases in children and prevalence further increases worldwide. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Healthy
- What is being tested?
- Cova Monitoring System 3
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 1 May 2019
- 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 4 to 17 years
- All sexes
- Child
Study population: Healthy volunteers
Who may be able to join
- Participant is between the ages of 4 - 17 years old at the time of consent
- Participant and/or family member/carer willing to give written consent
- Participant and/or family member/carer who can read and comprehend english
Who cannot join
- Subject believed to be unsuitable for inclusion by the Principle Investigator
- Subject is pregnant at time of consent
- Subject is currently enrolled in another medical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study to Detect Cough and Wheeze Sounds Using the CoVa Monitoring System 3
Asthma is a complex and chronic inflammatory disorder which is associated with reversible airway obstruction and bronchial hyperresponsiveness. It is one of the most prevalent chronic diseases in children and prevalence further increases worldwide. Typical symptoms of asthma are breathlessness, cough, wheezing and chest tightness. These symptoms are particularly prevalent at night-time. Understanding and tracking these symptoms can lead to better management of asthma.
Auscultation using a stethoscope is standard clinical practice, however there is currently no available solution to detect respiratory sounds throughout the day and night.
The aim of this study is to investigate the feasibility of detecting respiratory sounds in healthy children with the CoVa patch.
- Conditions
- Healthy
- Being tested
- Cova Monitoring System 3
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cova Monitoring System 3Device
Healthy Volunteers
| Study group | Role | What they receive |
|---|---|---|
| HealthyVolunteers | Not described Receives: Device: Cova Monitoring System 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to detect simulated respiratory sounds including coughing and wheezing or identify subjects which have asthma related respiratory issues
Subjects will be asked to simulate coughing and wheezing sounds. This data will be analyzed by using a phonocardiogram (microphone) sensor.
Measured: 2 Weeks
Secondary outcomes (1)
Ability to detect simulated respiratory sounds including wheeze and cough during movement such a simulated situation of moving in bed.
Subjects will be asked to simulate coughing and wheezing sounds. This data will be analyzed by using a phonocardiogram (microphone) sensor while the subject is moving in the bed.
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Apr 2019
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884582
- Sponsor's protocol ID
- RMD-IRB-0001
- Status last verified
- Apr 2019
- First submitted
- 17 Mar 2019
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Detect Cough and Wheeze Sounds Using the CoVa Monitoring System 3
- ClinicalTrials.gov ID
- NCT03884582
- Acronym / sponsor ID
- RMD-IRB-0001
- Conditions
- Healthy
- Keywords
- Healthy volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 21 Mar 2019 (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.
Asthma is a complex and chronic inflammatory disorder which is associated with reversible airway obstruction and bronchial hyperresponsiveness. It is one of the most prevalent chronic diseases in children and prevalence further increases worldwide. Typical symptoms of asthma are breathlessness, cough, wheezing and chest tightness. These symptoms are particularly prevalent at night-time. Understanding and tracking these symptoms can lead to better management of asthma.
Auscultation using a stethoscope is standard clinical practice, however there is currently no available solution to detect respiratory sounds throughout the day and night.
The aim of this study is to investigate the feasibility of detecting respiratory sounds in healthy children with the CoVa patch.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HealthyVolunteers | – | Device: Cova Monitoring System 3 |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Healthy volunteers
Key inclusion criteria (3 listed)
- Participant is between the ages of 4 - 17 years old at the time of consent
- Participant and/or family member/carer willing to give written consent
- Participant and/or family member/carer who can read and comprehend english
Key exclusion criteria (3 listed)
- Subject believed to be unsuitable for inclusion by the Principle Investigator
- Subject is pregnant at time of consent
- Subject is currently enrolled in another medical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cova Monitoring System 3Healthy Volunteers | Device | HealthyVolunteers |
Primary outcome
Ability to detect simulated respiratory sounds including coughing and wheezing or identify subjects which have asthma related respiratory issues
Time frame: 2 Weeks
Subjects will be asked to simulate coughing and wheezing sounds. This data will be analyzed by using a phonocardiogram (microphone) sensor.
1 secondary outcome
Ability to detect simulated respiratory sounds including wheeze and cough during movement such a simulated situation of moving in bed.
Time frame: 2 Weeks
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 Jan 2020.
- Individual participant dataSharing planned: No
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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 Healthy, run by Baxter Healthcare Corporation 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 3 inclusion and 3 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 Jan 2020. 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?
Ability to detect simulated respiratory sounds including coughing and wheezing or identify subjects which have asthma related respiratory issues (time frame: 2 Weeks). 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 Jan 2020.