EVAluation of the Non Inferiority of Interpretability of Cardiokin Compared to Holter

Study Overview
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Brief Summary
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The aim is to evaluate the electrocardiogram quality signal of the Cardioskin device and compare it with a Holter signal. For that, volunteers subjects will wear the Cardioskin and Holter, non-simultaneously, for about 24 hours. This study is open, and will be carried out according to a cross plan. The trial will include approximately 36-40 subjects between 18 and 70 years old.

Detailed Description
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The wear of the first device will be randomized. Each subject will wear the two devices. One group will start with a 24-hour environmental recording with Cardioskin and then will perform another recording of about 24 hours with the Holter. Conversely, group B will start with the Holter and then will continue with Cardioskin. It is a randomization software that will assign a group to each included participant. Each participant will come three times at hospital : one for inclusion and equipment of the first device, another to be unequipped and equipped of the second device. They will come another time to bring back the material. The total time of participation is of two days and half. The first aim is to evaluate if the signal interpretability is non-inferior to an Holter, for a recording of 24h (classic analysis of rhythm). The second aim is to evaluate if the 24 hours signal interpretability is non-inferior to an Holter in the case of a repolarization analysis. The third aim is to compare the comfort and usability between Cardioskin and Holter.

Official Title
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EVAluation of the Non Inferiority of Interpretability of Cardiokin Compared to Holter

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Device: Cardioskin
* Device: Holter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: people between 18 and 70 years old Exclusion Criteria: Minors Pregnant, parturient or breastfeeding women Refusal of consent Participant with known cardiac history Participant with cardiac arrhythmia observed during control ECG Participant who may be exposed to ionizing or electromagnetic radiation on days when devices (Cardioskin, Holter) will be worn Allergy to one of the components of the Cardioskin T-shirt, including: Polyamide - Polyester - Elastane - Other synthetic materials - Silicone - Silver Allergy to one of the components of the electrodes used for the Holter (Kendall 530 or similar) Sensory disturbances that make the participant unresponsive to pain Motor or mental disorders that prevent the participant from expressing their pain -Behavioral problems that make the participant excessively Agitated or Aggressive Cardiorespiratory disorders that may be aggravated by mild compression of the chest Weight and / or size not suitable for the proposed Cardioskin T-shirt designs Open wound on the skin in the area covered by Cardioskin textile or by the electrodes of the Holter Irritation, and / or erythema in the area covered by the Cardioskin textile or by the electrodes of the Holter Pregnancy clinically detectable or known to a participant Participant with a high infectious risk Person wearing breast prostheses Simultaneous participation in another search

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Monocentric, cross study, randomized
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cardioskin-Holter<br>Subjects in the randomized group A, start by wear the Cardioskin during 24h, and after wear the Holter during 24h. | Device: Cardioskin<br>* Subjects will have a 24h recording with Cardioskin, next will be unequipped.<br>Device: Holter<br>* Subjects will have a 24h recording with Holter, next will be unequipped.<br>|
| Other: Holter-Cardioskin<br>Subjects in the randomized group B, start by wear the Holter during 24h, and after wear the Cardioskin during 24h. | Device: Cardioskin<br>* Subjects will have a 24h recording with Cardioskin, next will be unequipped.<br>Device: Holter<br>* Subjects will have a 24h recording with Holter, next will be unequipped.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interpretability of signal | The quality signal will be assess blindly by rythm specialists. For that,specialists will show is the isoelectric line is stable (answer Yes No) | 48 hours | 
| interpretability of signal | The quality signal will be assess blindly by rythm specialists. For that,specialists will show the p waves are visible (answer Yes No) | 48 hours | 
| interpretability of signal | The quality signal will be assess blindly by rythm specialists. For that,specialists will show if the R pic are visible (answer Yes No) | 48 hours | 
| interpretability of signal | The quality signal will be assess blindly by rythm specialists. For that,specialists will show is the RR intervals are visible (answer Yes No) | 48 hours | 
| interpretability of signal | Cardiac observations will lead to a unique evaluation of the quality signal: either interpretable either non-interpretable (answer Yes No) | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interpretability of signal for a fine analysis of cardiac repolarization | The quality signal will be assess blindly by rythm specialists. For that, specialists will observe if the QRS width is measurable (answer Yes No) | 48 hours | 
| interpretability of signal for a fine analysis of cardiac repolarization | The quality signal will be assess blindly by rythm specialists. For that, specialists will observe if the T waves are visible (answer Yes No) | 48 hours | 
| interpretability of signal for a fine analysis of cardiac repolarization | The quality signal will be assess blindly by rythm specialists. For that, specialists will observe if the ST segment is analyzable (answer Yes No) | 48 hours | 
| interpretability of signal for a fine analysis of cardiac repolarization | The quality signal will be assess blindly by rythm specialists. For that, specialists will observe if the QT interval is measurable (answer Yes No) | 48 hours | 
| interpretability of signal for a fine analysis of cardiac repolarization | These cardiac observations will lead to a unique evaluation of the quality signal: either interpretable either non-interpretable (answer Yes No) | 48 hours | 
| evaluation of comfort | At the end of each recording, a subject will answer to a questionnary For comfort of the textile: Score of 0 to 70 points where 0 is comfortable and 70 is not comfortable. | 24 hours | 
| evaluation of usability | At the end of each recording, a subject will answer to a questionnary For usability of the system: score of 0 to 100 points where 0 is a bad usability and 100 is excellent | 24 hours |