Heart FailureNCT04305340
Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Population
A study testing Myant SKIIN Device in people with Heart Failure, run by Aamir Jeewa at 1 site in Canada.
Trial summary
There is a need for developing reliable and convenient technologies for telemonitoring of physiological signals such as respiration, cardiac function, and activity level in children and especially for those with heart disease. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Myant SKIIN Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2021to 30 Mar 2023
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy children participants (i.e. without CHD or HF) aged between 10 to 18 years with normal electrocardiograms and normal echocardiograms (i.e. screens for familial cardiomyopathy).
- OR
- Patients aged between 10 and 18 years with diagnosed congenital heart disease or cardiomyopathies referred to pediatric cardiology ambulatory clinic at SickKids.
Who cannot join
- In-hospital patients.
- Patients too ill to participate or perform any activity.
- Patients with Fontan/single ventricle physiology circulation.
- Children who are less than 6 months post op from a cardiac surgery as they will have concerns from an activity and wound care standpoint.
- Participants with known allergies to adhesives (as reported by family).
Trial locations and contacts
1 site in 1 country.
About this study
There is a need for developing reliable and convenient technologies for telemonitoring of physiological signals such as respiration, cardiac function, and activity level in children and especially for those with heart disease. Changing symptomatology causes heart failure patients to seek medical attention in order to be assessed and potentially have medication adjusted or additional testing being undertaken. These frequent clinical encounters affect the quality of life of these children and their parents, as well as being costly for the health care system. A textile based technology for telemonitoring application that is comfortable and accurate in its data collection can help to provide real time information on physiologic parameters. The primary research objective is to determine the feasibility and validity of a textile-enabled sensor system in measuring physiologic variables, or "biological signals", related to cardiopulmonary function in children. The study will include 10 patients with heart failure, and 10 healthy controls.
- Conditions
- Heart Failure
- Being tested
- Myant SKIIN Device
- Keywords
- Pediatric, Smart Device, Remote monitoring
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myant SKIIN DeviceDevice
- Supine position: Participant lays on a bed on their back for 5 minutes
- Sitting position: Participant sits on a chair for 5 minutes
- Standing position: Participant stands for 5 minutes.
- Exercise measurement: treadmill exercise test - the protocol entails increases of 0.5 mph every minute with zero change in the incline. Starting point would 1.5 mph. The test will be interrupted if the target heart rate of 190 beats per minute is reached or if symptoms and/or arrhythmias and ST depression would be observed. Patient will be monitor during recovery for 5 minutes.
- Cool-down: Participants cool-down for 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| SKIIN Textile Device in children with healthy hearts | Experimental | The Myant SKIIN Device will be worn by study participants while they lay down, sit, stand, exercise and cool-down. Receives: Device: Myant SKIIN Device |
| SKIIN Textile Device in children with heart failure | Experimental | The Myant SKIIN Device will be worn by study participants while they lay down, sit, stand, exercise and cool-down Receives: Device: Myant SKIIN Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate the heart rate measurements obtained using the SKIIN Textile in children with and without heart disease.
Validate the heart rate measurements obtained using the SKIIN Textile in children with and without heart disease compared to the measurements obtained by the Grael 4K PSG
Measured: 40 minutes
Validate the respiratory rate measurements obtained using the SKIIN Textile in children with and without heart disease.
Validate the respiratory rate measurements obtained using the SKIIN Textile in children with and without heart disease compared to the measurements obtained by the Grael 4K PSG.
Measured: 40 minutes
Validate the pulse oximetry measurements obtained using the SKIIN Textile in children with and without heart disease.
Validate the pulse oximetry measurements obtained using the SKIIN Textile in children with and without heart disease compared to the measurements obtained by the Nonin, WristOx2TM, Model 3150, Wrist-worn Pulse Oximeter
Measured: 40 minutes
Secondary outcomes (1)
To extract and analyze temperature data obtained using the SKIIN Textile in children with
To extract and analyze temperature data obtained using the SKIIN Textile in children with
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start15 Sep 2021
- Primary completion1 Apr 2022
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aamir Jeewa
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto Rehabilitation Institute
- Responsible party
- Sponsor-investigator, Aamir Jeewa, The Hospital for Sick Children
- Investigators
- Aamir Jeewa, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305340
- Sponsor's protocol ID
- CTO 1891
- Status last verified
- Jul 2023
- First submitted
- 29 Nov 2019
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Population
- ClinicalTrials.gov ID
- NCT04305340
- Acronym / sponsor ID
- CTO 1891
- Conditions
- Heart Failure
- Keywords
- Pediatric, Smart Device, Remote monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aamir JeewaUniversity, hospital or other
- Collaborators
- Toronto Rehabilitation Institute
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 12 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.
There is a need for developing reliable and convenient technologies for telemonitoring of physiological signals such as respiration, cardiac function, and activity level in children and especially for those with heart disease. Changing symptomatology causes heart failure patients to seek medical attention in order to be assessed and potentially have medication adjusted or additional testing being undertaken. These frequent clinical encounters affect the quality of life of these children and their parents, as well as being costly for the health care system. A textile based technology for telemonitoring application that is comfortable and accurate in its data collection can help to provide real time information on physiologic parameters. The primary research objective is to determine the feasibility and validity of a textile-enabled sensor system in measuring physiologic variables, or "biological signals", related to cardiopulmonary function in children. The study will include 10 patients with heart failure, and 10 healthy controls.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SKIIN Textile Device in children with healthy hearts | Experimental | Device: Myant SKIIN DeviceThe Myant SKIIN Device will be worn by study participants while they lay down, sit, stand, exercise and cool-down. |
| SKIIN Textile Device in children with heart failure | Experimental | Device: Myant SKIIN DeviceThe Myant SKIIN Device will be worn by study participants while they lay down, sit, stand, exercise and cool-down |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Healthy children participants (i.e. without CHD or HF) aged between 10 to 18 years with normal electrocardiograms and normal echocardiograms (i.e. screens for familial cardiomyopathy).
- OR
- Patients aged between 10 and 18 years with diagnosed congenital heart disease or cardiomyopathies referred to pediatric cardiology ambulatory clinic at SickKids.
Key exclusion criteria (5 listed)
- In-hospital patients.
- Patients too ill to participate or perform any activity.
- Patients with Fontan/single ventricle physiology circulation.
- Children who are less than 6 months post op from a cardiac surgery as they will have concerns from an activity and wound care standpoint.
- Participants with known allergies to adhesives (as reported by family).
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 |
|---|---|---|
| Myant SKIIN Device1. Supine position: Participant lays on a bed on their back for 5 minutes 2. Sitting position: Participant sits on a chair for 5 minutes 3. Standing position: Participant stands for 5 minutes. 4. Exercise measurement: treadmill exercise test - the protocol entails increases of 0.5 mph every minute with zero change in the incline. Starting point would 1.5 mph. The test will be interrupted if the target heart rate of 190 beats per minute is reached or if symptoms and/or arrhythmias and ST depression would be observed. Patient will be monitor during recovery for 5 minutes. 5. Cool-down: Participants cool-down for 5 minutes | Device | SKIIN Textile Device in children with healthy hearts, SKIIN Textile Device in children with heart failure |
Primary outcome
Validate the heart rate measurements obtained using the SKIIN Textile in children with and without heart disease.
Time frame: 40 minutes
Validate the heart rate measurements obtained using the SKIIN Textile in children with and without heart disease compared to the measurements obtained by the Grael 4K PSG
Validate the respiratory rate measurements obtained using the SKIIN Textile in children with and without heart disease.
Time frame: 40 minutes
Validate the respiratory rate measurements obtained using the SKIIN Textile in children with and without heart disease compared to the measurements obtained by the Grael 4K PSG.
Validate the pulse oximetry measurements obtained using the SKIIN Textile in children with and without heart disease.
Time frame: 40 minutes
Validate the pulse oximetry measurements obtained using the SKIIN Textile in children with and without heart disease compared to the measurements obtained by the Nonin, WristOx2TM, Model 3150, Wrist-worn Pulse Oximeter
1 secondary outcome
To extract and analyze temperature data obtained using the SKIIN Textile in children with
Time frame: 40 minutes
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 7 Jul 2023.
- Individual participant dataSharing planned: No
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HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
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Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
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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.
Aamir Jeewa, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myant SKIIN Device in people with Heart Failure, run by Aamir Jeewa at 1 site in Canada.
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 5 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 7 Jul 2023. 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 Canada. 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?
Validate the heart rate measurements obtained using the SKIIN Textile in children with and without heart disease. (time frame: 40 minutes). The study lists 3 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 7 Jul 2023.