Cardiac Arrhythmias
Conditions
Keywords
smart t-shirt, wearable, electrocardiogram
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.
Interventions
DEVICESmart t-shirt
24h ECG Monitoring with the smart t-shirt under study
DEVICEECG Holter
24h ECG Monitoring with ECG Holter
DEVICESmartwatch
24h ECG Monitoring with a smartwatch
Sponsors
AccYouRate S.p.A.
University of Bologna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electrocardiogram (ECG): Heart rate (beats per minute) | 24 hours | Smart t-shirt and ECG Holter comparison |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Electrocardiogram (ECG): Heart rate (beats per minute) | 24 hours | Smart t-shirt and smartwatch comparison |
Countries
Italy
Contacts
Primary ContactLuca Neri
Backup ContactClaudio Borghi
Outcome results
None listed