Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Population

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Device: Myant SKIIN Device

• Registration Number: NCT04305340
• Lead Sponsor: Aamir Jeewa

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-29
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-12
• Study Start: 2021-09-15
• Primary Completion: 2022-04-01
• Study Completion: 2023-03-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SKIIN Textile Device in children with healthy hearts	Myant SKIIN Device	The Myant SKIIN Device will be worn by study participants while they lay down, sit, stand, exercise and cool-down.
SKIIN Textile Device in children with heart failure	Myant SKIIN Device	The Myant SKIIN Device will be worn by study participants while they lay down, sit, stand, exercise and cool-down

Primary Outcome Measures

Name	Time	Method
Validate the respiratory rate measurements obtained using the SKIIN Textile in children with and without heart disease.	40 minutes	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.	40 minutes	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
Validate the heart rate measurements obtained using the SKIIN Textile in children with and without heart disease.	40 minutes	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

Secondary Outcome Measures

Name	Time	Method
To extract and analyze temperature data obtained using the SKIIN Textile in children with	40 minutes	To extract and analyze temperature data obtained using the SKIIN Textile in children with

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada