Healthy Volunteers Without Any Cardiac or Any Neurological Disorders Clinical Trial
Official title:
evaluatioN de la perfOrMAnce De Capteurs E-textiles
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.
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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