NCT04069390

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2021

Completed
Last Updated

November 13, 2019

Status Verified

April 1, 2019

Enrollment Period

1.5 years

First QC Date

August 23, 2019

Last Update Submit

November 11, 2019

Conditions

Healthy Volunteers Without Any Cardiac or Any Neurological Disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • performance sensors evaluation -long record

    nearly 2 months after each recruitement session

Study Arms (1)

Cardioskin-Neuronaute

EXPERIMENTAL
Device: CARDIOSKIN - Short recordDevice: Cardioskin - long recordDevice: Neuronaute - long recordDevice: Neuronaute -short record

Interventions

CARDIOSKIN - Short recordDEVICE

A short record (max 2H15) is performed with Cardioskin

Cardioskin-Neuronaute
Cardioskin - long recordDEVICE

A long record (max 8H) is performed with Cardioskin

Cardioskin-Neuronaute
Neuronaute - long recordDEVICE

A long record (max 8H) is performed with Neuronaute

Cardioskin-Neuronaute
Neuronaute -short recordDEVICE

A short record (max 2H15) is performed with Neuronaute

Cardioskin-Neuronaute

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Du Cerveau Et de La Moelle Epiniere

Paris, 75646, France

RECRUITING

Study Officials

  • remy WAHNOUN

    BioSerenity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleonore CAILLET, Ms

CONTACT

0156092017eleonore.caillet@bioserenity.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

July 9, 2019

Primary Completion

January 9, 2021

Study Completion

January 9, 2021

Last Updated

November 13, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)