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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Olfaction Disorders
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Enrollment
- 1000
- Primary Endpoint
- Enrollment and data collection
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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 brain's 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects over 18 years of age who have given consent for the collection of specified data, including medical history and personal information, for the purposes of project implementation and in accordance with the ethical standards of the institutions where the project will be conducted.
Exclusion Criteria
- •Previous fractures of the facial bones, particularly the ethmoid bone.
- •Active tumors of the brain or face, including tumors of the nose, paranasal sinuses, oral cavity, or nasopharynx.
- •Active nasal-sinus conditions, particularly radiologically proven sinusitis.
- •Mass in the pontocerebellar angle, especially schwannoma of the VIII nerve.
- •Patients with acute and chronic inflammatory diseases of the middle ear, otosclerosis, inner ear diseases (especially Meniere's disease), objective tinnitus, and tinnitus caused by middle ear pathologies and CPA tumors.
- •Neurodegenerative diseases (especially Alzheimer's and Parkinson's disease).
- •Known history of neuropsychiatric or cerebral disorders.
- •Use of psychotropic drugs or drugs active on the central nervous system.
- •Alcohol and drug abuse.
Outcomes
Primary Outcomes
Enrollment and data collection
Time Frame: 22 months
During this period, 1000 participants \> 18 y/o will be recruited and divided into four distinct groups: normosmics (550), hyposmics (150), tinnitus patients with hyposmia (150), and tinnitus patients without hyposmia (150). The primary outcome of the Neuroscent project is to assess the ability of EEG analysis to distinguish between normosmic and hyposmic participants during olfactory stimulation using the Sniffin' Sticks test.
EEG Parameters (in µV²)
Time Frame: 22 months
Alpha Power: Measured in microvolts squared (µV²), representing the magnitude of Alpha wave activity during olfactory stimulation. Theta Power: Measured in microvolts squared (µV²), representing the magnitude of Theta wave activity during olfactory stimulation. We will make use of the Fourier transform as well, which is inherently dimensionless. The data acquisition setup involves placing blindfolded participants in an isolated room and administering three randomized olfactory stimuli (pure olfactory, trigeminal, and olfactory-gustatory) while collecting EEG data. Sessions start and end with a 30-second resting state.
Behavioral/Performance Measures (Scores)
Time Frame: 22 months
Olfactory Threshold Scores (as per routinary diagnosis of olfactory performances): Derived from the Sniffin' Sticks test, these scores quantify participants' ability to detect odors, classifying them as normosmic or hyposmic. All the participants will undergo a complete olfactory assessment through the Sniffin' Sticks test. These are represented as numerical scores. The maximum score obtainable in the full Sniffin' Sticks test, which includes the three sub-tests (Threshold, Discrimination, Identification - TDI), is 48. This maximum score is achieved by summing the highest possible score from each of the three components: 16 for olfactory threshold (Threshold), 16 for olfactory discrimination (Discrimination), and 16 for olfactory identification (Identification).
Model Performance Metrics (Accuracy)
Time Frame: 22 months
Random Forest Model Classification Accuracy: The accuracy of the classification model used to distinguish between normosmic and hyposmic participants based on EEG data, usually expressed as a percentage or a value between 0 and 1.
Dimensionality Change Outputs (t-SNE)
Time Frame: 22 months
t-SNE Features: Although these don't have a specific unit, they represent the reduced dimensional data points used as features in the Random Forest model. These are typically dimensionless and used in the context of visualizing and improving model performance.
Secondary Outcomes
- Pure Tone Audiometry Test(22 months (Simultaneously with the primary outcome))
- Behavioral/Performance Measures (Scores)(22 months (Simultaneously with the primary outcome))
- EEG Parameters(22 months (Simultaneously with the primary outcome))
- Model Performance Metrics(22 months (Simultaneously with the primary outcome))
- Power Analysis and Post-hoc Analyses(22 months (Simultaneously with the primary outcome))
- Auditory Brainstem Response (ABR)(22 months (Simultaneously with the primary outcome))
- Tympanometry(22 months (Simultaneously with the primary outcome))