Healthy Volunteers
Conditions
Brief summary
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
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.
Interventions
DEVICECardioskin
Subjects will have a 24h recording with Cardioskin, next will be unequipped.
DEVICEHolter
Subjects will have a 24h recording with Holter, next will be unequipped.
Sponsors
BioSerenity
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Monocentric, cross study, randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| interpretability of signal | 48 hours | The quality signal will be assess blindly by rythm specialists. For that,specialists will show is the isoelectric line is stable (answer Yes No) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| interpretability of signal for a fine analysis of cardiac repolarization | 48 hours | The quality signal will be assess blindly by rythm specialists. For that, specialists will observe if the QRS width is measurable (answer Yes No) |
| evaluation of comfort | 24 hours | 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. |
| evaluation of usability | 24 hours | 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 |
Countries
France
Outcome results
None listed