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OpenTrials
Completed

NCT Number: NCT05113602

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ESPCI

Paris, 75005, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

URGOnight

Device

EEG dry electrodes portable device

Enobio

Device

EEG wet electrodes portable device

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. To compare the measurement performed by URGOnight to the measurement performed by the Enobio 20 device of SMR rhythm

    Time frame: 10 min recording

  3. 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

Other outcomes

  1. Optimize protocols to identify and distinguish individual Alpha and SMR peaks

    Time frame: 20 min recording

Sponsors and collaborators

Lead sponsor

Urgotech

Industry

Collaborators

  • ESPCI Paris

Registry information

Acronym: SIGMA

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 9, 2021
Registry last updated
Nov 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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