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The NOMADE study has a dual purpose:
Different EC and non-CE models of Neuronaute and Cardioskin may be tested in this study.
Bioserenity develops innovative solutions, using smart clothing that can be used in hospitals or homes, in short or long term. Without wires, these washable textiles allow, in particular, the measurement of biophysiological signals via a recording box, while allowing the participant the freedom to continue his daily activities.
In order to perfect Bioserenity products, new types of non-invasive sensors will be integrated to offer a new range of multimodal and polygraphic products. Moreover, in order to optimise the already EC devices, they have evolved slightly in terms of textile and software.
Participants will perform at least one recording session with one of the study devices, Neuronaute or Cardioskin. After that, they can hold other meetings if they wish. For this they will not be specially summoned, they will have to volunteer when they wish to participate. The model and type of Bioserenity device (Neuronaute or Cardioskin) may change depending on the session. The recording context may also change. Throughout the duration of the study, whether participants wish to participate regularly or not, they will in all cases be limited to two participation sessions per week. They can stop at any time, without having to justify themselves. The investigation centre will adapt to the availability of the participants and their willingness to participate: the aim is to generate them no constraints.
During recording, subjects may be asked to do small, simple exercises, which differ depending on the recorded signal. Sometimes the exercises can be repeated with a non-invasive device of the market, with minimal risks and constraints, in order to be able to perform a comparison of signals
The principal aim evaluate the performance of Cardioskin or Neuronaute device sensors over short-term recording periods.
The secondary aim is to evaluate the performance of Cardioskin or Neuronaute device sensors over long-term recording periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardioskin-Neuronaute | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CARDIOSKIN - Short record | Device | A short record (max 2H15) is performed with Cardioskin |
|
| Measure | Description | Time Frame |
|---|---|---|
| performance sensors evaluation -short record | signal quality will be assessed as "acceptable" or "not acceptable" for interprétation | nearly 2 months after each recruitement session |
| Measure | Description | Time Frame |
|---|---|---|
| performance sensors evaluation -long record | signal quality will be assessed as "acceptable" or "not acceptable" for interpretation | nearly 2 months after each recruitement session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eleonore CAILLET, Ms | Contact | 0156092017 | eleonore.caillet@bioserenity.com |
| Name | Affiliation | Role |
|---|---|---|
| remy WAHNOUN | BioSerenity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Du Cerveau Et de La Moelle Epiniere | Recruiting | Paris | 75646 | France |
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| Cardioskin - long record | Device | A long record (max 8H) is performed with Cardioskin |
|
| Neuronaute - long record | Device | A long record (max 8H) is performed with Neuronaute |
|
| Neuronaute -short record | Device | A short record (max 2H15) is performed with Neuronaute |
|