[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561377":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":34,"centralContacts":38,"locations":43,"responsibleParty":48,"collaborators":43,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":43,"enrollmentInfo":61,"targetDuration":43,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":77,"whyStopped":43,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":43},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Normosmic","ACTIVE_COMPARATOR","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\n(n=550)",[13],"Diagnostic Test: Sniffin'Sticks",{"label":15,"type":10,"description":16,"interventionNames":17},"Hyposmic","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)",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Tinnitus Patients with Hyposmia","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)",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Tinnitus Patients without Hyposmia","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)",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIAGNOSTIC_TEST","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 stimuli. Both the Sniffin' Sticks test and EEG recordings are conducted simultaneously, providing a dual assessment of behavioral reactions and brain activity to odors. The goal of the study is to compare brain wave patterns and olfactory function in normosmic (normal smell), hyposmic (reduced smell), and tinnitus patients with and without olfactory impairments, delivering comprehensive insights into the neural basis of olfactory perception.",[15,9,19,23],[33],"EEG",[35],{"name":36,"affiliation":5,"role":37},"Giulio Cesare Passali, Prof","STUDY_DIRECTOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Giuseppe Maulucci, Prof","CONTACT","+390630154265",null,"giuseppe.maulucci@unicatt.it",{"name":36,"role":41,"phone":46,"phoneExt":43,"email":47},"3331727194","giuliocesarepassali@policlinicogemelli.it",{"type":49,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100561377","study-of-eeg-and-nasal-stimulus-in-olfactory-disorders-100561377",false,"NCT06589375","Study of EEG and Nasal Stimulus in Olfactory Disorders","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","SENSO","Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Previous fractures of the facial bones, particularly the ethmoid bone.\n* Active tumors of the brain or face, including tumors of the nose, paranasal sinuses, oral cavity, or nasopharynx.\n* Active nasal-sinus conditions, particularly radiologically proven sinusitis.\n* Mass in the pontocerebellar angle, especially schwannoma of the VIII nerve.\n* 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.\n* Neurodegenerative diseases (especially Alzheimer's and Parkinson's disease).\n* Known history of neuropsychiatric or cerebral disorders.\n* Use of psychotropic drugs or drugs active on the central nervous system.\n* Alcohol and drug abuse.",true,"ALL","18 Years",{"count":62,"type":63},1000,"ESTIMATED","INTERVENTIONAL",[66],"NA","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",[69],"Olfaction Disorders",[71,33,72,73,74,75,76],"Olfactory stimuli","Tinnitus","Olfactory disorders","Smell impairment","Olfactometry","Brain waves","NOT_YET_RECRUITING","2024-09-05",{"date":80,"type":81},"2024-09-19","ACTUAL",{"date":83,"type":63},"2024-08-31",{"date":85,"type":63},"2026-08-31",{"name":5,"class":6}]