Asthma in ChildrenNCT04873193
Safety and Feasibility of a Novel Device for Assessing Respiratory Function in Children
A study testing Leo device in people with Asthma in Children, run by ResMed at 1 site in United States.
Trial summary
This is an early phase pilot study designed to test the safety and feasibility of using a novel, wireless, wearable device (Leo) for assessing respiratory parameters (lung volume, respiration rate, heart rate and indices related to tidal breathing flow volume loop) in children with respiratory condition (such as… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Leo device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 21 Jan 2022
- Phase
- Interventional
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged ≥3 years old and ≤18 years old at time of consent
- Children with a legal guardian able to sign consent for study participation
- Children and caregivers able to read and understand English or Spanish
- Investigator confirmation for diagnosis of clinically stable respiratory condition, such as clinically diagnosed asthma
- Children who are able to follow instructions and complete oscillometry and tidal breathing tasks
Who cannot join
- - Children <3 and >18 years of age
- Adults (age ≥ 18 years)
- Children with complex medical conditions which may hinder their ability to complete protocol assessments
- Children who do not have a legal guardian to sign informed consent form
- Children with an active skin condition involving the area on the chest wall where the Leo device will be attached. E.g. inflamed and/or infected eczema or other skin conditions involving the anterior chest wall at the time of recruitment
- Child is determined not eligible by the assessment of the PI
Show all 10Show fewer
- Fever within the 4 weeks prior to enrollment
- Children with any implanted medical devices, E.g. cardiac pacemaker
- Children with any history of known allergic reaction to adhesives or hydrogels, as the ones used with the Leo device
- Children who have taken a bronchodilator in the last 8-24 hours prior to study visit, depending on the type of medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Safety and Feasibility of Utilizing a Novel Wearable Device (Leo) for Assessing Respiratory Function in Children With Respiratory Condition - a Pilot Early Phase Clinical Study
This is an early phase pilot study designed to test the safety and feasibility of using a novel, wireless, wearable device (Leo) for assessing respiratory parameters (lung volume, respiration rate, heart rate and indices related to tidal breathing flow volume loop) in children with respiratory condition (such as asthma).
There is no product currently on the market that is comparable to this novel Leo device
Read more
The study consists of a single visit to evaluate the feasibility and safety of using the Leo device on 20 children with clinically stable asthma.
Stable asthmatic children between the age of 3 and 6, inclusive, will be recruited.
There will be no disease-specific intervention, nor changes to the participant's care management program for their asthma.
- Conditions
- Asthma in Children
- Being tested
- Leo device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leo deviceDevice
Also called Pneumotachometer (BioPaC systems, Inc., Goleta, CA, USA) connected to anti-bacterial filter and mouth piece.
Children's respiratory flow and volume measurements will be continuously recorded using the Leo device during oscillometry and pneumotach procedures.
| Study group | Role | What they receive |
|---|---|---|
| Oscillometry + Pneumotach Procedure with Leo Device measurements | Other | All patients will undergo oscillometry procedure, followed by pneumotach procedure to measure tidal volume in different sitting positions. The Leo device will be worn throughout both procedures to measure the chest electrical impedance and compare against pneumotach measurements.
Oscillometry and pneumotach are part of standard of care. Receives: Device: Leo device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slow vital capacity from Leo device
Agreement and correlation in the lung function parameters derived using the respiratory impedance signals recorded from Leo device, compared to the pneumotachograph (PNT) device. The PNT device readings will be considered the standard of care, and compared against the Leo device to evaluate for device feasibility. This will be done before and after administration of bronchodilator.
Measured: Baseline
Slow vital capacity from PNT device
Agreement and correlation in the lung function parameters derived using the respiratory impedance signals recorded from Leo device, compared to the pneumotachograph (PNT) device. The PNT device readings will be considered the standard of care, and compared against the Leo device to evaluate for device feasibility. This will be done before and after administration of bronchodilator.
Measured: Baseline
Tidal breathing from Leo device
Agreement and correlation in tidal breathing parameters between Leo and the pneumotachograph (PNT) device. The PNT device parameters are considered standard of care, and will be compared against Leo device to evaluate for device feasibility. This will be done before and after administration of bronchodilator.
Measured: Baseline
Tidal breathing from PNT device
Agreement and correlation in tidal breathing parameters between Leo and the pneumotachograph (PNT) device. The PNT device parameters are considered standard of care, and will be compared against Leo device to evaluate for device feasibility. This will be done before and after administration of bronchodilator.
Measured: Baseline
Secondary outcomes (1)
Usability
Clinician, patient and caregiver usability feedback on the use of the Leo device through an IRB approved participant questionnaire.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start1 Jul 2021
- Primary completion21 Jan 2022
- Study completion21 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Liu, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873193
- Sponsor's protocol ID
- OTH-21-02-01
- Status last verified
- Sep 2022
- First submitted
- 22 Apr 2021
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data only
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Utilizing a Novel Wearable Device (Leo) for Assessing Respiratory Function in Children With Respiratory Condition - a Pilot Early Phase Clinical Study
- ClinicalTrials.gov ID
- NCT04873193
- Acronym / sponsor ID
- OTH-21-02-01
- Conditions
- Asthma in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 21 Jan 2022 (actual)
- First posted
- 5 May 2021 (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.
This is an early phase pilot study designed to test the safety and feasibility of using a novel, wireless, wearable device (Leo) for assessing respiratory parameters (lung volume, respiration rate, heart rate and indices related to tidal breathing flow volume loop) in children with respiratory condition (such as asthma).
There is no product currently on the market that is comparable to this novel Leo device
The study consists of a single visit to evaluate the feasibility and safety of using the Leo device on 20 children with clinically stable asthma.
Stable asthmatic children between the age of 3 and 6, inclusive, will be recruited.
There will be no disease-specific intervention, nor changes to the participant's care management program for their asthma.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oscillometry + Pneumotach Procedure with Leo Device measurements | Other | Device: Leo deviceAll patients will undergo oscillometry procedure, followed by pneumotach procedure to measure tidal volume in different sitting positions. The Leo device will be worn throughout both procedures to measure the chest electrical impedance and compare against pneumotach measurements. Oscillometry and pneumotach are part of standard of care. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Children aged ≥3 years old and ≤18 years old at time of consent
- Children with a legal guardian able to sign consent for study participation
- Children and caregivers able to read and understand English or Spanish
- Investigator confirmation for diagnosis of clinically stable respiratory condition, such as clinically diagnosed asthma
- Children who are able to follow instructions and complete oscillometry and tidal breathing tasks
Key exclusion criteria (10 listed)
- - Children <3 and >18 years of age
- Adults (age ≥ 18 years)
- Children with complex medical conditions which may hinder their ability to complete protocol assessments
- Children who do not have a legal guardian to sign informed consent form
- Children with an active skin condition involving the area on the chest wall where the Leo device will be attached. E.g. inflamed and/or infected eczema or other skin conditions involving the anterior chest wall at the time of recruitment
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 |
|---|---|---|
| Leo deviceAlso: Pneumotachometer (BioPaC systems, Inc., Goleta, CA, USA) connected to anti-bacterial filter and mouth piece.Children's respiratory flow and volume measurements will be continuously recorded using the Leo device during oscillometry and pneumotach procedures. | Device | Oscillometry + Pneumotach Procedure with Leo Device measurements |
Primary outcome
Slow vital capacity from Leo device
Time frame: Baseline
Agreement and correlation in the lung function parameters derived using the respiratory impedance signals recorded from Leo device, compared to the pneumotachograph (PNT) device. The PNT device readings will be considered the standard of care, and compared against the Leo device to evaluate for device feasibility. This will be done before and after administration of bronchodilator.
Slow vital capacity from PNT device
Time frame: Baseline
Agreement and correlation in the lung function parameters derived using the respiratory impedance signals recorded from Leo device, compared to the pneumotachograph (PNT) device. The PNT device readings will be considered the standard of care, and compared against the Leo device to evaluate for device feasibility. This will be done before and after administration of bronchodilator.
Tidal breathing from Leo device
Time frame: Baseline
Agreement and correlation in tidal breathing parameters between Leo and the pneumotachograph (PNT) device. The PNT device parameters are considered standard of care, and will be compared against Leo device to evaluate for device feasibility. This will be done before and after administration of bronchodilator.
Tidal breathing from PNT device
Time frame: Baseline
Agreement and correlation in tidal breathing parameters between Leo and the pneumotachograph (PNT) device. The PNT device parameters are considered standard of care, and will be compared against Leo device to evaluate for device feasibility. This will be done before and after administration of bronchodilator.
1 secondary outcome
Usability
Time frame: Baseline
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 26 Sep 2022.
- Individual participant dataSharing planned: Yes. De-identified data only
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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.
Andrew Liu principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leo device in people with Asthma in Children, run by ResMed 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 5 inclusion and 10 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 26 Sep 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?
Slow vital capacity from Leo device (time frame: Baseline). The study lists 4 primary outcomes in all. 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 26 Sep 2022.