Evaluation of an Innovative Smart T-shirt Capable to Monitor ECG Signal and Related Parameters Through the Comparison With a Holter ECG and a Smartwatch (Youcare)

University of Bologna

Status

Enrolling

Conditions

Cardiac Arrhythmias

Treatments

Device: Smartwatch

Device: Smart t-shirt

Device: ECG Holter

Study type

Observational

Funder types

Other

Identifiers

NCT05771142

Smart_t-shirt_2021

156/2022/Disp/AOUBo (Other Identifier)

Details and patient eligibility

About

Evaluation of an innovative smart t-shirt capable to monitor ECG signal and related parameters through the comparison with a Holter ECG and a smartwatch

Full description

The primary purpose of this study is to evaluate the biosignal (ECG) acquisition features of the smart t-shirt, developed by University of Bologna in collaboration with AccYouRate S.p.A., comparing it with a standard Holter ECG. Secondly, the study wants to compare the parameters related to ECG signal calculated by the smart t-shirt with those calculated by commercial smartwatches.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects agree to participate in the study and having dated and signed the informed consent form,
Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements,
Male or female aged ≥ 18 years and ≤ 90 years old,
Subjects with Cardiac electrophysiological (heart rhythm) pathologies or under screening for the assessment of possible cardiac electrophysiological pathologies.

Exclusion criteria

Subjects that for different reasons have difficulties to wear the sensorized t-shirt or the alternative sensorized chest band: Movement's impairments; Dermatological reaction to t-shirt fabric or materials,
Any medical or surgical condition that would limit the patient adhesion to the study protocol,
Severe obesity and sever underweight,
Subject that are not able to understand the scope of the study.