Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT05113602
Status:
COMPLETED
Last Update Posted:
2021-11-09
First Post:
2021-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of the EEG Signal Quality Measured by the URGOnight Device and Comparison With a Clinical Device
Sponsor:
Urgotech
Organization:
Study Overview
Official Title:
Validation of the EEG Signal Quality Measured by the URGOnight Device and Comparison With a Clinical Device
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIGMA
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: