Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589375
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Study of EEG and Nasal Stimulus in Olfactory Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neuroscent EEG Analysis of Cortical Signals Induced by Olfactory Stimuli in Normosmic Subjects and Individuals With Olfactory Disorders With an In-depth Study of Olfactory Pathways in Patients With Tinnitus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SENSO
Brief Summary:
Neuroscent aims to analyze EEG signals induced by olfactory stimuli in individuals with normal and impaired olfactory functions with a focus on patients with tinnitus The study seeks to develop reliable diagnostic methods using EEG to differentiate between normosmic and hyposmic subjects during olfactory tests potentially enhancing our understanding of the brains response to olfactory stimuli This 24-month interventional study with a device to be patented will involve 1000 participants and aims to establish more effective diagnostic and therapeutic tools for olfactory disorders
Detailed Description:
The Neuroscent project investigates the EEG signals elicited by olfactory stimuli in both normosmic individuals and those with olfactory disorders with a focus on tinnitus patients The primary objective is to utilize EEG analysis to identify and quantify brain wave responses during olfactory tests with Sniffin Sticks aiming to accurately differentiate between normosmic and hyposmic subjects This research aims to enhance the diagnostic precision and understanding of the interplay between olfactory and auditory stimuli in the brain The 24-month interventional study with a device to be patented co-financed by the Ministry of Health and Ministry of the Interior under the PNRR 2023 will recruit 1000 participants divided into four groups normosmics 550 hyposmics 150 tinnitus patients with hyposmia 150 and tinnitus patients without hyposmia 150 Participants will undergo comprehensive olfactory assessments including the Sniffin Sticks test and EEG recordings will be taken during olfactory stimulation to capture brain wave patterns Advanced data analysis techniques such as Random Forest algorithms and t-SNE dimensionality reduction will be employed to classify and interpret the EEG signals aiming to develop effective diagnostic and therapeutic tools for olfactory disorders thereby improving clinical outcomes and quality of life for affected individuals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None