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Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Population

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Myant SKIIN Device
Sponsored by
Aamir Jeewa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring Pediatric, Smart Device, Remote monitoring

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SKIIN Textile Device in children with healthy hearts

SKIIN Textile Device in children with heart failure

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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.
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

Secondary Outcome Measures

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

Full Information

First Posted
November 29, 2019
Last Updated
July 6, 2023
Sponsor
Aamir Jeewa
Collaborators
Toronto Rehabilitation Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04305340
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
March 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aamir Jeewa
Collaborators
Toronto Rehabilitation Institute

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Pediatric, Smart Device, Remote monitoring

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SKIIN Textile Device in children with healthy hearts
Arm Type
Experimental
Arm Description
The Myant SKIIN Device will be worn by study participants while they lay down, sit, stand, exercise and cool-down.
Arm Title
SKIIN Textile Device in children with heart failure
Arm Type
Experimental
Arm Description
The Myant SKIIN Device will be worn by study participants while they lay down, sit, stand, exercise and cool-down
Intervention Type
Device
Intervention Name(s)
Myant SKIIN Device
Intervention Description
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
Primary Outcome Measure Information:
Title
Validate the heart rate measurements obtained using the SKIIN Textile in children with and without heart disease.
Description
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
Time Frame
40 minutes
Title
Validate the respiratory rate measurements obtained using the SKIIN Textile in children with and without heart disease.
Description
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.
Time Frame
40 minutes
Title
Validate the pulse oximetry measurements obtained using the SKIIN Textile in children with and without heart disease.
Description
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
Time Frame
40 minutes
Secondary Outcome Measure Information:
Title
To extract and analyze temperature data obtained using the SKIIN Textile in children with
Description
To extract and analyze temperature data obtained using the SKIIN Textile in children with
Time Frame
40 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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). OR 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aamir Jeewa, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Population

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