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
Youcare
2 other identifiers
observational
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2023
CompletedFirst Posted
Study publicly available on registry
March 16, 2023
CompletedStudy Start
First participant enrolled
March 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedMarch 16, 2023
February 1, 2023
1 month
February 10, 2023
March 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Electrocardiogram (ECG): Heart rate (beats per minute)
24 hours
Study Arms (1)
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
Interventions
24h ECG Monitoring with the smart t-shirt under study
24h ECG Monitoring with a smartwatch
Eligibility Criteria
The study will be conducted in subjects with heart rhythm pathologies or under assessment of possible heart rhythm pathologies.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Bolognalead
- AccYouRate S.p.A.collaborator
Study Sites (1)
Policlinico Sant'Orsola Malpighi - University of Bologna
Bologna, 40138, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor/Dean
Study Record Dates
First Submitted
February 10, 2023
First Posted
March 16, 2023
Study Start
March 27, 2023
Primary Completion
May 1, 2023
Study Completion
May 31, 2023
Last Updated
March 16, 2023
Record last verified: 2023-02