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Clinical Trials/NCT04305340
NCT04305340
Completed
Not Applicable

Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Population

Aamir Jeewa1 site in 1 country20 target enrollmentSeptember 15, 2021
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Aamir Jeewa
Enrollment
20
Locations
1
Primary Endpoint
Validate the respiratory rate measurements obtained using the SKIIN Textile in children with and without heart disease.
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 15, 2021
End Date
March 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aamir Jeewa
Responsible Party
Sponsor Investigator
Principal Investigator

Aamir Jeewa

Staff Cardiologist

The Hospital for Sick Children

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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

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

Secondary Outcomes

  • To extract and analyze temperature data obtained using the SKIIN Textile in children with(40 minutes)

Study Sites (1)

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