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

Recruiting

• Conditions: Cardiac Arrhythmias

• Registration Number: NCT05771142
• Lead Sponsor: University of Bologna

Brief Summary

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

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.

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-10
• Study First Submitted QC: 2023-03-14
• Last Update Submitted: 2023-03-14
• Study First Posted: 2023-03-16
• Last Update Posted: 2023-03-16
• Study Start: 2023-03-27
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

1. 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,
2. Any medical or surgical condition that would limit the patient adhesion to the study protocol,
3. Severe obesity and sever underweight,
4. Subject that are not able to understand the scope of the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Electrocardiogram (ECG): Heart rate (beats per minute)	24 hours	Smart t-shirt and smartwatch comparison

Trial Locations

Locations (1)

Policlinico Sant'Orsola Malpighi - University of Bologna; 🇮🇹 Bologna, Italy