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| Name | Class |
|---|---|
| Toronto Rehabilitation Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myant SKIIN Device | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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 | 40 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 40 minutes |
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Inclusion Criteria
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.
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Aamir Jeewa, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G1X8 | Canada |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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