Healthy Volunteers Without Any Cardiac or Any Neurological DisordersNOMADENCT04069390
evaluatioN de la perfOrMAnce De Capteurs E-textiles
A study testing CARDIOSKIN - Short record, Cardioskin - long record and Neuronaute - long record in people with Healthy Volunteers Without Any Cardiac or Any Neurological Disorders, run by BioSerenity at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers Without Any Cardiac or Any Neurological Disorders
- What is being tested?
- CARDIOSKIN - Short record, Cardioskin - long record and Neuronaute - long record
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jul 2019to 9 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male, female at least 18 years
- Membership of a social security scheme
Who cannot join
- 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.)
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut Du Cerveau Et de La Moelle Epiniere
Paris, 75646
eleonore caillet, eleonore.caillet@bioserenity.com
About this study
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.
Read the 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.
- Being tested
- CARDIOSKIN - Short record, Cardioskin - long record, Neuronaute - long record, Neuronaute -short record
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARDIOSKIN - Short recordDevice
A short record (max 2H15) is performed with Cardioskin
Cardioskin - long recordDevice
A long record (max 8H) is performed with Cardioskin
Neuronaute - long recordDevice
A long record (max 8H) is performed with Neuronaute
Neuronaute -short recordDevice
A short record (max 2H15) is performed with Neuronaute
| Study group | Role | What they receive |
|---|---|---|
| Cardioskin-Neuronaute | Experimental | Not described Receives: Device: CARDIOSKIN - Short record; Device: Cardioskin - long record; Device: Neuronaute - long record; Device: Neuronaute -short record |
What is being measured
The primary outcome is the main question the study is designed to answer.
performance sensors evaluation -short record
signal quality will be assessed as "acceptable" or "not acceptable" for interprétation
Measured: nearly 2 months after each recruitement session
Secondary outcomes (1)
performance sensors evaluation -long record
signal quality will be assessed as "acceptable" or "not acceptable" for interpretation
Measured: nearly 2 months after each recruitement session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start9 Jul 2019
- Primary completion9 Jan 2021 (estimated)
- Study completion9 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers Without Any Cardiac or Any Neurological DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioSerenity
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- remy WAHNOUN, Principal investigator, BioSerenity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069390
- Sponsor's protocol ID
- 2019-A00745-52
- Acronym
- NOMADE
- Status last verified
- Apr 2019
- First submitted
- 23 Aug 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- evaluatioN de la perfOrMAnce De Capteurs E-textiles
- ClinicalTrials.gov ID
- NCT04069390
- Acronym / sponsor ID
- NOMADE / 2019-A00745-52
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- BioSerenityIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 9 Jan 2021 (estimated)
- Study completion
- 9 Jan 2021 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardioskin-Neuronaute | Experimental | Device: CARDIOSKIN - Short record, Device: Cardioskin - long record, Device: Neuronaute - long record, Device: Neuronaute -short record |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male, female at least 18 years
- Membership of a social security scheme
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARDIOSKIN - Short recordA short record (max 2H15) is performed with Cardioskin | Device | Cardioskin-Neuronaute |
| Cardioskin - long recordA long record (max 8H) is performed with Cardioskin | Device | Cardioskin-Neuronaute |
| Neuronaute - long recordA long record (max 8H) is performed with Neuronaute | Device | Cardioskin-Neuronaute |
| Neuronaute -short recordA short record (max 2H15) is performed with Neuronaute | Device | Cardioskin-Neuronaute |
Primary outcome
performance sensors evaluation -short record
Time frame: nearly 2 months after each recruitement session
signal quality will be assessed as "acceptable" or "not acceptable" for interprétation
1 secondary outcome
performance sensors evaluation -long record
Time frame: nearly 2 months after each recruitement session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
remy WAHNOUN principal investigator
BioSerenity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARDIOSKIN - Short record, Cardioskin - long record and Neuronaute - long record in people with Healthy Volunteers Without Any Cardiac or Any Neurological Disorders, run by BioSerenity at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eleonore CAILLET, Ms (0156092017, eleonore.caillet@bioserenity.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
performance sensors evaluation -short record (time frame: nearly 2 months after each recruitement session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.