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Validation of the EEG Signal Quality Measured by the URGOnight Device and Comparison With a Clinical Device

Validation of the EEG Signal Quality Measured by the URGOnight Device and Comparison With a Clinical Device

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05113602
Acronym
SIGMA
Enrollment
35
Registered
2021-11-09
Start date
2021-01-26
Completion date
2021-06-30
Last updated
2021-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volonteers

Brief 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. 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.

Interventions

DEVICEURGOnight

EEG dry electrodes portable device

DEVICEEnobio

EEG wet electrodes portable device

Sponsors

ESPCI Paris
CollaboratorOTHER
Urgotech
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frame
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.5 min recording

Secondary

MeasureTime frame
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 hertz5 min recording
To compare the measurement performed by URGOnight to the measurement performed by the Enobio 20 device of SMR rhythm10 min recording
To compare the measurement performed by URGOnight to the measurement performed by the Enobio 20 device of Individual Alpha frequencies10 min recording

Other

MeasureTime frame
Optimize protocols to identify and distinguish individual Alpha and SMR peaks20 min recording

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026