Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Population

Heart Failure Clinical Trial

Official title:

Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04305340
• Other study ID #: CTO 1891
• Status: Completed
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: March 30, 2023

Study information

• Verified date: July 2023
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 30, 2023
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Aamir Jeewa	Toronto Rehabilitation Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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