Cardiac ArrhythmiasYoucareNCT05771142
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
An observational study of Cardiac Arrhythmias, run by University of Bologna at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiac Arrhythmias
- What is being tested?
- Smart t-shirt, ECG Holter and Smartwatch
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 27 Mar 2023to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted in subjects with heart rhythm pathologies or under assessment of possible heart rhythm pathologies.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Claudio Borghi contact
Italy1 site, 1 recruiting
- Recruiting
Policlinico Sant'Orsola Malpighi - University of Bologna
Bologna, 40138
Claudio Borghi, MD, +390512144291, claudio.borghi@unibo.it
About this study
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
Read the 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.
- Conditions
- Cardiac Arrhythmias
- Being tested
- Smart t-shirt, ECG Holter, Smartwatch
- Keywords
- smart t-shirt, wearable, electrocardiogram
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart t-shirtDevice
24h ECG Monitoring with the smart t-shirt under study
ECG HolterDevice
24h ECG Monitoring with ECG Holter
SmartwatchDevice
24h ECG Monitoring with a smartwatch
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Smart t-shirt; Device: ECG Holter; Device: Smartwatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrocardiogram (ECG): Heart rate (beats per minute)
Smart t-shirt and ECG Holter comparison
Measured: 24 hours
Electrocardiogram (ECG): RR interval (seconds)
Smart t-shirt and ECG Holter comparison
Measured: 24 hours
Electrocardiogram (ECG): Qualitative distinction of P-waves, QRS-complexes, T-waves, and noise levels
Smart t-shirt and ECG Holter comparison
Measured: 24 hours
Secondary outcomes (1)
Electrocardiogram (ECG): Heart rate (beats per minute)
Smart t-shirt and smartwatch comparison
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start27 Mar 2023 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- AccYouRate S.p.A.
- Responsible party
- Principal investigator, Claudio Borghi, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771142
- Sponsor's protocol ID
- Smart_t-shirt_2021
- Other IDs
- 156/2022/Disp/AOUBo
- Acronym
- Youcare
- Status last verified
- Feb 2023
- First submitted
- 10 Feb 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05771142
- Acronym / sponsor ID
- Youcare / Smart_t-shirt_2021
- Conditions
- Cardiac Arrhythmias
- Keywords
- smart t-shirt, wearable, electrocardiogram
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Collaborators
- AccYouRate S.p.A.
- Study start
- 27 Mar 2023 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smart t-shirt, ECG Holter and smartwatch patients | – | Device: Smart t-shirt, Device: ECG Holter, Device: Smartwatch24h ECG Monitoring - All participants will wear the smart t-shirt, the ECG Holter and the smartwatch at the same time |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted in subjects with heart rhythm pathologies or under assessment of possible heart rhythm pathologies.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart t-shirt24h ECG Monitoring with the smart t-shirt under study | Device | Smart t-shirt, ECG Holter and smartwatch patients |
| ECG Holter24h ECG Monitoring with ECG Holter | Device | Smart t-shirt, ECG Holter and smartwatch patients |
| Smartwatch24h ECG Monitoring with a smartwatch | Device | Smart t-shirt, ECG Holter and smartwatch patients |
Primary outcome
Electrocardiogram (ECG): Heart rate (beats per minute)
Time frame: 24 hours
Smart t-shirt and ECG Holter comparison
Electrocardiogram (ECG): RR interval (seconds)
Time frame: 24 hours
Smart t-shirt and ECG Holter comparison
Electrocardiogram (ECG): Qualitative distinction of P-waves, QRS-complexes, T-waves, and noise levels
Time frame: 24 hours
Smart t-shirt and ECG Holter comparison
1 secondary outcome
Electrocardiogram (ECG): Heart rate (beats per minute)
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Borghi contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmias, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Neri (+14432538858, luca.neri9@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrocardiogram (ECG): Heart rate (beats per minute) (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.