Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Validate the respiratory rate measurements obtained using the SKIIN Textile in children with and without heart disease.
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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).
- •Patients aged between 10 and 18 years with diagnosed congenital heart disease or cardiomyopathies referred to pediatric cardiology ambulatory clinic at SickKids.
Exclusion Criteria
- •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).
Arms & Interventions
SKIIN Textile Device in children with healthy hearts
The Myant SKIIN Device will be worn by study participants while they lay down, sit, stand, exercise and cool-down.
Intervention: Myant SKIIN Device (Device)
SKIIN Textile Device in children with heart failure
The Myant SKIIN Device will be worn by study participants while they lay down, sit, stand, exercise and cool-down
Intervention: Myant SKIIN Device (Device)
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- To extract and analyze temperature data obtained using the SKIIN Textile in children with(40 minutes)
Investigators
Aamir Jeewa
Staff Cardiologist
The Hospital for Sick Children