Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Population

NCT04305340 | Completed

• 1 other identifier: CTO 1891
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Pediatric; Smart Device; Remote monitoring

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• To extract and analyze temperature data obtained using the SKIIN Textile in children with

  40 minutes

Study Arms (2)

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.

Device: Myant SKIIN Device

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

Device: Myant SKIIN Device

Interventions

Myant SKIIN Device DEVICE

1. Supine position: Participant lays on a bed on their back for 5 minutes 2. Sitting position: Participant sits on a chair for 5 minutes 3. Standing position: Participant stands for 5 minutes. 4. 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. 5. Cool-down: Participants cool-down for 5 minutes

SKIIN Textile Device in children with healthy hearts; SKIIN Textile Device in children with heart failure

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Aamir Jeewa: lead
• Toronto Rehabilitation Institute: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Aamir Jeewa, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Cardiologist

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: March 12, 2020
• Study Start: September 15, 2021
• Primary Completion: April 1, 2022
• Study Completion: March 30, 2023
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)