Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Population

Aamir Jeewa

Status: Completed

Conditions: Heart Failure

Treatments: Device: Myant SKIIN Device

Study type: Interventional

Funder types: Other

Identifiers

NCT04305340

CTO 1891

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

SKIIN Textile Device in children with healthy hearts

Experimental group

Description:

The Myant SKIIN Device will be worn by study participants while they lay down, sit, stand, exercise and cool-down.

Treatment:

Device: Myant SKIIN Device

SKIIN Textile Device in children with heart failure

Experimental group

Description:

The Myant SKIIN Device will be worn by study participants while they lay down, sit, stand, exercise and cool-down

Treatment:

Device: Myant SKIIN Device