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

Cardiac Arrhythmias Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05771142
• Other study ID #: Smart_t-shirt_2021
• Secondary ID: 156/2022/Disp/AO
• Status: Recruiting
• Start date: March 27, 2023
• Est. completion date: May 31, 2023

Study information

• Verified date: February 2023
• Source: University of Bologna
• Contact: Luca Neri
• Phone: +14432538858
• Email: luca.neri9[@]unibo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 31, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmias

Intervention

Device:
• Smart t-shirt
24h ECG Monitoring with the smart t-shirt under study
• ECG Holter
24h ECG Monitoring with ECG Holter
• Smartwatch
24h ECG Monitoring with a smartwatch

Locations

Country	Name	City	State
Italy	Policlinico Sant'Orsola Malpighi - University of Bologna	Bologna

Sponsors (2)

Lead Sponsor	Collaborator
University of Bologna	AccYouRate S.p.A.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrocardiogram (ECG): Heart rate (beats per minute)	Smart t-shirt and ECG Holter comparison	24 hours
Primary	Electrocardiogram (ECG): RR interval (seconds)	Smart t-shirt and ECG Holter comparison	24 hours
Primary	Electrocardiogram (ECG): Qualitative distinction of P-waves, QRS-complexes, T-waves, and noise levels	Smart t-shirt and ECG Holter comparison	24 hours
Secondary	Electrocardiogram (ECG): Heart rate (beats per minute)	Smart t-shirt and smartwatch comparison	24 hours