MedTrace Logo

Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Population

NCT04305340 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-07-07

No results posted yet for this study

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

Interventions

DEVICE

Myant SKIIN 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

Sponsors & Collaborators

  • Toronto Rehabilitation Institute

    collaborator OTHER

  • Aamir Jeewa

    lead OTHER

Principal Investigators

  • Aamir Jeewa, MD · The Hospital for Sick Children

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2022-04-01
Completion
2023-03-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04305340 on ClinicalTrials.gov