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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Cardiac Arrhythmias

Intervention / Treatment
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* Device: Smart t-shirt
* Device: ECG Holter
* Device: Smartwatch


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Smart t-shirt, ECG Holter and smartwatch patients<br>24h ECG Monitoring - All participants will wear the smart t-shirt, the ECG Holter and the smartwatch at the same time | Device: Smart t-shirt<br>* 24h ECG Monitoring with the smart t-shirt under study<br>Device: ECG Holter<br>* 24h ECG Monitoring with ECG Holter<br>Device: Smartwatch<br>* 24h ECG Monitoring with a smartwatch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrocardiogram (ECG): Heart rate (beats per minute) | Smart t-shirt and ECG Holter comparison | 24 hours | 
| Electrocardiogram (ECG): RR interval (seconds) | Smart t-shirt and ECG Holter comparison | 24 hours | 
| Electrocardiogram (ECG): Qualitative distinction of P-waves, QRS-complexes, T-waves, and noise levels | Smart t-shirt and ECG Holter comparison | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrocardiogram (ECG): Heart rate (beats per minute) | Smart t-shirt and smartwatch comparison | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smart t-shirt, wearable, electrocardiogram