Study of EEG and Nasal Stimulus in Olfactory Disorders (SENSO)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Olfaction Disorders

Treatments: Diagnostic Test: Sniffin'Sticks

Study type: Interventional

Funder types: Other

Identifiers

NCT06589375

ID6911

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 4 patient groups

Normosmic

Active Comparator group

Description:

Participants in this group have normal olfactory function, as determined by the Sniffin' Sticks test. They will undergo EEG analysis while being exposed to various olfactory stimuli to establish baseline brain wave patterns for normal olfactory responses. (n=550)

Treatment:

Diagnostic Test: Sniffin'Sticks

Hyposmic

Active Comparator group

Description:

Participants in this group have impaired olfactory function (hyposmia), confirmed through the Sniffin' Sticks test. They will undergo EEG analysis during olfactory stimulation to identify differences in brain wave patterns compared to normosmic individuals. (n=150)

Treatment:

Diagnostic Test: Sniffin'Sticks

Tinnitus Patients with Hyposmia

Active Comparator group

Description:

This group includes participants who have both tinnitus and hyposmia. They will be subjected to EEG analysis during olfactory testing to investigate the interaction between olfactory and auditory disorders and how these conditions may influence brain wave responses. (n=150)

Treatment:

Diagnostic Test: Sniffin'Sticks

Tinnitus Patients without Hyposmia

Active Comparator group

Description:

Participants in this group have tinnitus but normal olfactory function. They will undergo the same EEG and olfactory tests to explore the impact of tinnitus on brain wave patterns in the absence of olfactory disorders and to compare their responses with those of other groups. (n=150)

Treatment:

Diagnostic Test: Sniffin'Sticks