NCT04069390

evaluatioN de la perfOrMAnce De Capteurs E-textiles

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: BioSerenity · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The NOMADE study has a dual purpose: * Test the performance of new types of sensors that are likely to integrate Bioserenity devices and will therefore improve them. * Test the performance of the sensors of Bioserenity CE devices and their advanced versions Different EC and non-CE models of Neuronaute and Cardioskin may be tested in this study.

Detailed description

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.

Conditions

• Healthy Volunteers Without Any Cardiac or Any Neurological Disorders

Interventions

Type	Name	Description
DEVICE	CARDIOSKIN - Short record	A short record (max 2H15) is performed with Cardioskin
DEVICE	Cardioskin - long record	A long record (max 8H) is performed with Cardioskin
DEVICE	Neuronaute - long record	A long record (max 8H) is performed with Neuronaute
DEVICE	Neuronaute -short record	A short record (max 2H15) is performed with Neuronaute

Timeline

• Start date: 2019-07-09
• Primary completion: 2021-01-09
• Completion: 2021-01-09
• First posted: 2019-08-28
• Last updated: 2019-11-13

Locations

1 site across 1 country: France