Study of EEG and Nasal Stimulus in Olfactory Disorders

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Диагностический тест Sniffin'Sticks
  The Sniffin' Sticks test, a validated method to evaluate olfactory functions, utilizes pen-like devices to dispense scents for testing identification, discrimination, and detection of odors. In this study, participants' responses to various scents are recorded. EEG (Electroencephalography) captures electrical activity in the brain during exposure to these odors by using an EEG cap fitted with electrodes on the scalp. This allows for the monitoring of brain wave patterns in response to olfactory

Первичные конечные точки

• Enrollment and data collection [Срок оценки: 22 months]
• EEG Parameters (in µV²) [Срок оценки: 22 months]
• Behavioral/Performance Measures (Scores) [Срок оценки: 22 months]
• Model Performance Metrics (Accuracy) [Срок оценки: 22 months]
• Dimensionality Change Outputs (t-SNE) [Срок оценки: 22 months]

Вторичные конечные точки (7)

• Pure Tone Audiometry Test [Срок оценки: 22 months (Simultaneously with the primary outcome)]
• Behavioral/Performance Measures (Scores) [Срок оценки: 22 months (Simultaneously with the primary outcome)]
• EEG Parameters [Срок оценки: 22 months (Simultaneously with the primary outcome)]
• Model Performance Metrics [Срок оценки: 22 months (Simultaneously with the primary outcome)]
• Power Analysis and Post-hoc Analyses [Срок оценки: 22 months (Simultaneously with the primary outcome)]
• Auditory Brainstem Response (ABR) [Срок оценки: 22 months (Simultaneously with the primary outcome)]
• Tympanometry [Срок оценки: 22 months (Simultaneously with the primary outcome)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06589375 · ID6911

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗