Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Population

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 Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Myant SKIIN Device

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Myant SKIIN Device; 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
Experimental: 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	Device: Myant SKIIN Device; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Aamir Jeewa
• Collaborators: Toronto Rehabilitation Institute
• Investigators: Principal Investigator: Aamir Jeewa, MD, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: November 29, 2019
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 12, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Pediatric; Remote monitoring; Smart Device
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CTO 1891

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No