Olfactory Training in Various Populations

Study Overview
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Brief Summary
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To date, there is no validated pharmacotherapy for olfactory disorders. Interestingly, olfactory training - the intentional exposure to odorants for the purposes of retraining the sense of smell - has shown success with as many as 28% of subjects over the course of 12 weeks.

Detailed Description
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Study Objectives: The overall, primary goals of these studies are as follows: To compare the outcomes of our olfactory testing battery for olfactory training to the previously published literature To determine if using a larger panel of odorants (our 15 scents versus the 4 scents previously used in the literature) yields a significant difference in olfactory recovery.

Official Title
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Olfactory Training in Various Populations

Conditions
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Olfactory Disorder, Smell Disorder, Traumatic Brain Injury, Concussion, Brain

Intervention / Treatment
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* Other: Smell Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: history of traumatic brain injury ability to complete objective olfactory tests and comply with olfactory training protocol Exclusion Criteria: Anyone lower than the age of 18, or greater than the age of 80 Pregnant women, as sinonasal symptoms and changes in smell can occur in pregnancy and are multifactorial Patients with poor or questionable compliance, as participation requires daily compliance with study protocol Patient's that are unable to perform routine follow-up Patients who are participating in another study during this trial Patients with dementia, Alzheimer's disease, Parkinson's disease, or other neurocognitive disorders, as these conditions are associated with baseline olfactory dysfunction. Patients with other systemic conditions known to impact the sinonasal cavity such as Wegener's granulomatosis, Churg Strauss, and immunodeficiency, as their impact on olfaction is unknown Patients who are allergic to any of the smells or components of our olfactory testing and training

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: 4 scents<br>Participants will be asked to inhale 4 different scents 2 times a day. | Other: Smell Test<br>* Oils are used for each of the different scents. Each scent is administered via an aromatherapy inhaling stick.<br>|
| Active Comparator: Group B: 14 scents<br>Participants will be asked to inhale 14 different scents 2 times a day. | Other: Smell Test<br>* Oils are used for each of the different scents. Each scent is administered via an aromatherapy inhaling stick.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Olfactory Threshold | Changes in olfactory threshold when comparing pre- and post-olfactory training for performance in terms of percent correct per specific scent and overall combination of percent correct for all tested scents | Change from baseline to month 6 | 
| Olfactory Identification | Changes in ability to detect and identify scents when comparing pre- and post-olfactory training for percent detected per individual scents and as a composite score reflecting performance on all scents | Change from baseline to month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance with Olfactory Training Protocol | Self-reported tolerance with following olfactory training protocol | At follow-up visits | 
| Neurocognition | Assessment of neurocognition and impact on olfactory quality of life using the Mini-Mental Status Exam (MMSE) and Montreal Cognitive Assessment (MoCA) | Change from baseline to month 6 |