Clinical trial NCT06589375: Study of EEG and Nasal Stimulus in Olfactory Disorders
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Olfaction Disorders
Keywords: Olfactory stimuli
EEG
Tinnitus
Olfactory disorders
Smell impairment
Olfactometry
Brain waves
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study involves multiple groups of participants who will undergo EEG analysis during olfactory stimulation to assess brain wave responses. The groups include normosmics, hyposmics, tinnitus patients with hyposmia, and tinnitus patients without hyposmia. The study aims to differentiate between these groups and investigate the relationship between olfactory disorders and also highlight the olfactory features of patients with tinnitus. Each group will receive the same olfactory tests and EEG recordings, but they will be compared against each other to understand the different responses and interactions.
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Enrollment and data collection
timeFrame: 22 months
measure: EEG Parameters (in µV²)
timeFrame: 22 months
measure: Behavioral/Performance Measures (Scores)
timeFrame: 22 months
measure: Model Performance Metrics (Accuracy)
timeFrame: 22 months
measure: Dimensionality Change Outputs (t-SNE)
timeFrame: 22 months
Secondary outcomes:
measure: Pure Tone Audiometry Test
timeFrame: 22 months (Simultaneously with the primary outcome)
measure: Behavioral/Performance Measures (Scores)
timeFrame: 22 months (Simultaneously with the primary outcome)
measure: EEG Parameters
timeFrame: 22 months (Simultaneously with the primary outcome)
measure: Model Performance Metrics
timeFrame: 22 months (Simultaneously with the primary outcome)
measure: Power Analysis and Post-hoc Analyses
timeFrame: 22 months (Simultaneously with the primary outcome)
measure: Auditory Brainstem Response (ABR)
timeFrame: 22 months (Simultaneously with the primary outcome)
measure: Tympanometry
timeFrame: 22 months (Simultaneously with the primary outcome)
Other outcomes:
measure: Predicting Odor Categories in Tinnitus and Non-Tinnitus Groups Using EEG and Machine Learning
timeFrame: 2 months
Locations:
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Giulio Cesare Passali, Prof
role: STUDY_DIRECTOR
References: