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

NCT ID: NCT05771142

Last Updated: 2023-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-27

Study Completion Date

2023-05-31

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.

Conditions

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Cardiac Arrhythmias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Smart t-shirt, ECG Holter and smartwatch patients

24h ECG Monitoring - All participants will wear the smart t-shirt, the ECG Holter and the smartwatch at the same time

Smart t-shirt

Intervention Type DEVICE

24h ECG Monitoring with the smart t-shirt under study

ECG Holter

Intervention Type DEVICE

24h ECG Monitoring with ECG Holter

Smartwatch

Intervention Type DEVICE

24h ECG Monitoring with a smartwatch

Interventions

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Smart t-shirt

24h ECG Monitoring with the smart t-shirt under study

Intervention Type DEVICE

ECG Holter

24h ECG Monitoring with ECG Holter

Intervention Type DEVICE

Smartwatch

24h ECG Monitoring with a smartwatch

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AccYouRate S.p.A.

UNKNOWN

Sponsor Role collaborator

University of Bologna

OTHER

Sponsor Role lead

Responsible Party

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Claudio Borghi

Professor/Dean

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Policlinico Sant'Orsola Malpighi - University of Bologna

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Luca Neri

Role: CONTACT

+14432538858

Claudio Borghi

Role: CONTACT

Facility Contacts

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Claudio Borghi, MD

Role: primary

+390512144291

Other Identifiers

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156/2022/Disp/AOUBo

Identifier Type: OTHER

Identifier Source: secondary_id

Smart_t-shirt_2021

Identifier Type: -

Identifier Source: org_study_id

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