Healthy VolonteersSIGMANCT05113602
Validation of the EEG Signal Quality Measured by the URGOnight Device and Comparison With a Clinical Device
A study testing URGOnight and Enobio in people with Healthy Volonteers, run by Urgotech at 1 site in France.
Trial summary
The electroencephalogram or EEG is a painless and non-invasive exploratory examination routinely performed in clinical and experimental medicine and has various applications. It is therefore relevant to develop application-specific EEG measurement devices. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volonteers
- What is being tested?
- URGOnight and Enobio
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2021to 30 Jun 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years old
- Head circumference between 52 and 62 centimeters
- Affiliated or beneficiary of a social security system
- Protected persons in the sense of article L.1121-9 of the Public Health Code.
Who cannot join
- According to declarative :
- Use of medication or drugs with a possible effect on cognitive performance, such as benzodiazepines, antidepressants and antipsychotics
- Epilepsy
- The experimenter cannot get a good signal between the scalp and the electrodes at the beginning of the experiment (for example because of the type of hair or for any other technical reason).
Trial locations and contacts
1 site in 1 country.
About this study
The electroencephalogram or EEG is a painless and non-invasive exploratory examination routinely performed in clinical and experimental medicine and has various applications. It is therefore relevant to develop application-specific EEG measurement devices.
The clinical development of therapies based on brain control has led to the emergence of numerous EEG devices that aim to allow mobile, autonomous, and easy use for users.
Read more
Data from the literature have proven the ability of neurofeedback (a form of biofeedback in which subjects respond to a display of their own brainwaves in order to improve their health or performance) to improve brain function in healthy or pathological subjects.
These therapeutic applications are offered in hospital settings with conventional systems and in the presence of a therapist.
The EEG measurement device URGOnight was developed with the aim of offering autonomous neurofeedback exercises at home. URGOnight is a portable device. It uses passive electrodes (which do not send an electric current) and so-called dry electrodes, i.e. no gel or conductive paste is required.
Therefore, the SIGMA study aims to evaluate the quality of the EEG signal collected by URGOnight and compare it with an electroencephalography device commonly used in clinical and research settings.
We will also evaluate the quality of the brain wave measurement usually retained in comparative studies of EEG systems.
- Conditions
- Healthy Volonteers
- Being tested
- URGOnight, Enobio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
URGOnightDevice
EEG dry electrodes portable device
EnobioDevice
EEG wet electrodes portable device
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous acquisition of EEG signals | Experimental | Not described Receives: Device: URGOnight; Device: Enobio |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of the URGOnight device in detecting brain signals triggered by eye closure in the Alpha band (8-12 Hz) in comparison with the Enobio 20 device.
Measured: 5 min recording
Secondary outcomes (3)
To compare the measurement performed by URGOnight to the measurement performed by the Enobio 20 device of Visual evoked potentials SSVEP at 4, 8, 10, 13, 15 and 20 hertz
Measured: 5 min recording
To compare the measurement performed by URGOnight to the measurement performed by the Enobio 20 device of SMR rhythm
Measured: 10 min recording
To compare the measurement performed by URGOnight to the measurement performed by the Enobio 20 device of Individual Alpha frequencies
Measured: 10 min recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start26 Jan 2021
- Primary completion30 Jan 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolonteersStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urgotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ESPCI Paris
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113602
- Sponsor's protocol ID
- SIGMA
- Acronym
- SIGMA
- Status last verified
- Oct 2021
- First submitted
- 28 Oct 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the EEG Signal Quality Measured by the URGOnight Device and Comparison With a Clinical Device
- ClinicalTrials.gov ID
- NCT05113602
- Acronym / sponsor ID
- SIGMA / SIGMA
- Conditions
- Healthy Volonteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- UrgotechIndustry (pharma, biotech, devices)
- Collaborators
- ESPCI Paris
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 9 Nov 2021 (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 electroencephalogram or EEG is a painless and non-invasive exploratory examination routinely performed in clinical and experimental medicine and has various applications. It is therefore relevant to develop application-specific EEG measurement devices.
The clinical development of therapies based on brain control has led to the emergence of numerous EEG devices that aim to allow mobile, autonomous, and easy use for users.
Data from the literature have proven the ability of neurofeedback (a form of biofeedback in which subjects respond to a display of their own brainwaves in order to improve their health or performance) to improve brain function in healthy or pathological subjects.
These therapeutic applications are offered in hospital settings with conventional systems and in the presence of a therapist.
The EEG measurement device URGOnight was developed with the aim of offering autonomous neurofeedback exercises at home. URGOnight is a portable device. It uses passive electrodes (which do not send an electric current) and so-called dry electrodes, i.e. no gel or conductive paste is required.
Therefore, the SIGMA study aims to evaluate the quality of the EEG signal collected by URGOnight and compare it with an electroencephalography device commonly used in clinical and research settings.
We will also evaluate the quality of the brain wave measurement usually retained in comparative studies of EEG systems.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simultaneous acquisition of EEG signals | Experimental | Device: URGOnight, Device: Enobio |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years old
- Head circumference between 52 and 62 centimeters
- Affiliated or beneficiary of a social security system
- Protected persons in the sense of article L.1121-9 of the Public Health Code.
Key exclusion criteria (4 listed)
- According to declarative :
- Use of medication or drugs with a possible effect on cognitive performance, such as benzodiazepines, antidepressants and antipsychotics
- Epilepsy
- The experimenter cannot get a good signal between the scalp and the electrodes at the beginning of the experiment (for example because of the type of hair or for any other technical reason).
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 |
|---|---|---|
| URGOnightEEG dry electrodes portable device | Device | Simultaneous acquisition of EEG signals |
| EnobioEEG wet electrodes portable device | Device | Simultaneous acquisition of EEG signals |
Primary outcome
effectiveness of the URGOnight device in detecting brain signals triggered by eye closure in the Alpha band (8-12 Hz) in comparison with the Enobio 20 device.
Time frame: 5 min recording
3 secondary outcomes
To compare the measurement performed by URGOnight to the measurement performed by the Enobio 20 device of Visual evoked potentials SSVEP at 4, 8, 10, 13, 15 and 20 hertz
Time frame: 5 min recording
To compare the measurement performed by URGOnight to the measurement performed by the Enobio 20 device of SMR rhythm
Time frame: 10 min recording
To compare the measurement performed by URGOnight to the measurement performed by the Enobio 20 device of Individual Alpha frequencies
Time frame: 10 min recording
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing URGOnight and Enobio in people with Healthy Volonteers, run by Urgotech 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 9 Nov 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of the URGOnight device in detecting brain signals triggered by eye closure in the Alpha band (8-12 Hz) in comparison with the Enobio 20 device. (time frame: 5 min recording). 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 9 Nov 2021.