Clinical trial NCT04305340: Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Population
Official title: Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Pediatric
Smart Device
Remote monitoring
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Toronto Rehabilitation Institute
First posted: 2020-03-12
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria

1. 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
2. Patients aged between 10 and 18 years with diagnosed congenital heart disease or cardiomyopathies referred to pediatric cardiology ambulatory clinic at SickKids.

Exclusion Criteria

1. In-hospital patients.
2. Patients too ill to participate or perform any activity.
3. Patients with Fontan/single ventricle physiology circulation.
4. 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.
5. Participants with known allergies to adhesives (as reported by family).

Primary outcomes:
measure: Validate the heart rate measurements obtained using the SKIIN Textile in children with and without heart disease.
timeFrame: 40 minutes
measure: Validate the respiratory rate measurements obtained using the SKIIN Textile in children with and without heart disease.
timeFrame: 40 minutes
measure: Validate the pulse oximetry measurements obtained using the SKIIN Textile in children with and without heart disease.
timeFrame: 40 minutes
Secondary outcomes:
measure: To extract and analyze temperature data obtained using the SKIIN Textile in children with
timeFrame: 40 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Aamir Jeewa, MD
role: PRINCIPAL_INVESTIGATOR
References: