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Completed

NCT Number: NCT04305340

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Myant SKIIN Device

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

Primary outcomes

  1. Validate the heart rate measurements obtained using the SKIIN Textile in children with and without heart disease.

    Time frame: 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

  2. Validate the respiratory rate measurements obtained using the SKIIN Textile in children with and without heart disease.

    Time frame: 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.

  3. Validate the pulse oximetry measurements obtained using the SKIIN Textile in children with and without heart disease.

    Time frame: 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

Secondary outcomes

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

    Time frame: 40 minutes

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

Sponsors and collaborators

Lead sponsor

Aamir Jeewa

Other

Collaborators

  • Toronto Rehabilitation Institute

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 12, 2020
Registry last updated
Jul 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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