NCT03805243

Brief Summary

BioSerenity suggests developing innovative solutions, from intelligent clothes which can be used in a hospital environment or at home. These textiles allow, in particular, to measure the biophysiological signals while letting to the participant the freedom pursue its daily activities. BioSerenity has already developed two wearable wireless and portable medical devices: cardioskin with textile ECG electrods , and the Neuronaute with textile EEG, EMG electrods. The aim of the study is to test these sensors to optimize their signal to integrate them in future Bioserenity devices like a somnonaute to help diagnosis of sleep disorders, like uronaute to help diagnosis of urination disorders, like toconaute to help monitoring of pregnancy. Others CE-marked sensors developed by others manufacturers will be tested to choose those that will be integrated in the Bioserenity devices.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

April 23, 2018

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

November 29, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2020

Completed
Last Updated

November 11, 2021

Status Verified

November 1, 2021

Enrollment Period

1.1 years

First QC Date

April 23, 2018

Last Update Submit

November 5, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Sensor quality validation

    Signal is considered as of "good quality" " not good quality" regarding criteria of signal patterns : eg amplitude of signal, regularity..

    24 months

Study Arms (5)

test of sensors for somnonaute device

EXPERIMENTAL

monitoring with sensors

Device: test of sensors for somnonaute device

test of sensors for uronaute device

EXPERIMENTAL

monitoring with sensors

Device: test of sensors for uronaute device

test of sensors for toconaute device

EXPERIMENTAL

monitoring with sensors

Device: test of sensors for toconaute device

test of sensors for cardioskin device

EXPERIMENTAL

monitoring with sensors

Device: test of sensors for cardioskin device

test of sensors for neuronaute device

EXPERIMENTAL

monitoring with sensors

Device: test of sensors for neuronaute device

Interventions

test of sensors for somnonaute deviceDEVICE

test of sensors

test of sensors for somnonaute device
test of sensors for uronaute deviceDEVICE

test of sensors

test of sensors for uronaute device
test of sensors for toconaute deviceDEVICE

test of sensors

test of sensors for toconaute device
test of sensors for neuronaute deviceDEVICE

test of sensors

test of sensors for neuronaute device
test of sensors for cardioskin deviceDEVICE

test of sensors

test of sensors for cardioskin device

Eligibility Criteria

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

You may qualify if:

  • women or men \>18 years
  • affiliation to a social security system

You may not qualify if:

  • Wounds or wounds on the body and the scalp;
  • Refusal of consent, minor
  • Not membership to the Social Security
  • Participant not capable of following the procedure of use (according to the judgment of the investigator);
  • Brain surgery that took place less than a week ago
  • Allergy known about the money, the polyamide, the silicone, the synthetic materials;
  • Sensory Disorders(Confusions) returning the insensible subject to the pain;
  • Motor or mental disorders preventing the subject from expressing his pain;
  • Behavioral problems that make the subject excessively agitated or aggressive;
  • People with cardio-respiratory problems likely to be aggravated by the slight compression of the thorax;
  • Subject equipped with an electrical stimulation device;
  • Unsuitable anthropometric Parameters (for the women, the sizes superior to 24 will be excluded and for the men(people) those superior to 34);
  • Pregnancy clinically detectable or known for the subject;
  • Current(in class) Participation in a clinical trial or participation in a previous clinical trial understanding(including) a period of not past(over) deficiency at the time of this clinical trial.
  • Predisposition in the headaches of tension (the compression exercised by the hat(cap) can activate(start) in certain cases a headache);
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Du Cerveau Et de La Moelle Epiniere

Paris, 75646, France

Location

Study Officials

  • quang TRAN

    BioSerenity

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: All subject would likely test each the 5 devices
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2018

First Posted

January 15, 2019

Study Start

November 29, 2019

Primary Completion

December 21, 2020

Study Completion

December 21, 2020

Last Updated

November 11, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)