evaluatioN de la perfOrMAnce De Capteurs E-textiles (NOMADE)

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Volunteers Without Any Cardiac or Any Neurological Disorders
• Intervention / Treatment: Device: CARDIOSKIN - Short record; Device: Cardioskin - long record; Device: Neuronaute - long record; Device: Neuronaute -short record

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75646
    • Recruiting
    • Institut du Cerveau et de la Moelle Epinière
    • Contact: eleonore caillet; Email: eleonore.caillet@bioserenity.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male, female at least 18 years
• Membership of a social security scheme

Exclusion Criteria:

• Minors
• Refusal of consent
• Allergy to one of the components of Bioserenity products, including:Polyamide (other polymers),Polyester,Elasthanne,Polyethylene/polyopropylene (other polymers),Titanium,Silicone,Silver/Copper,Other synthetic materials
• Allergy to one of the components present in commercial electrodes (gel electrode type Kendall 530 or similar; or electrodes type Ag/Agcl; or other electrodes containing in particular: acrylate/polyacrylate, acrylic acid, Impedimed electrodes, etc.)
• Allergy to one of the components in an electroconductive cream for sensors (Elefix, Ten20 and similar biocompatible product)
• Known allergy to one of the components in a commercial EEG helmet (neoprene, elastomer, silicone, etc.)
• Sensory disorders that make the participant insensitive to pain
• Motor or mental disorders that prevent the participant from expressing pain
• Behavioural disorders that make the participant excessively agitated or aggressive
• Person protected

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardioskin-Neuronaute	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: BioSerenity
• Investigators: Principal Investigator: remy WAHNOUN, BioSerenity

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2019
• Primary Completion (Anticipated): January 9, 2021
• Study Completion (Anticipated): January 9, 2021

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 11, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: 2019-A00745-52

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No