Concussion, Brain, Olfactory Disorder, Smell Disorder, Traumatic Brain Injury
Conditions
Brief summary
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
Study Objectives: The overall, primary goals of these studies are as follows: 1. To compare the outcomes of our olfactory testing battery for olfactory training to the previously published literature 2. 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.
Interventions
OTHERSmell Test
Oils are used for each of the different scents. Each scent is administered via an aromatherapy inhaling stick.
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 * Quantifiable or subjective olfactory dysfunction * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Olfactory Threshold | Change from baseline to month 6 | 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 |
| Olfactory Identification | Change from baseline to month 6 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance with Olfactory Training Protocol | At follow-up visits | Self-reported tolerance with following olfactory training protocol |
| Neurocognition | Change from baseline to month 6 | Assessment of neurocognition and impact on olfactory quality of life using the Mini-Mental Status Exam (MMSE) and Montreal Cognitive Assessment (MoCA) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDonald D Beahm, MD
University of Kansas Medical Center
Outcome results
None listed