Olfactory Training in Various Populations
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Study Objectives: The overall, primary goals of these studies are as follows:
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To compare the outcomes of our olfactory testing battery for olfactory training to the previously published literature
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A: 4 scents Participants will be asked to inhale 4 different scents 2 times a day. |
Other: Smell Test
Oils are used for each of the different scents. Each scent is administered via an aromatherapy inhaling stick.
|
| Active Comparator: Group B: 14 scents Participants will be asked to inhale 14 different scents 2 times a day. |
Other: Smell Test
Oils are used for each of the different scents. Each scent is administered via an aromatherapy inhaling stick.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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history of traumatic brain injury
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ability to complete objective olfactory tests and comply with olfactory training protocol
Exclusion Criteria:
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Anyone lower than the age of 18, or greater than the age of 80
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Pregnant women, as sinonasal symptoms and changes in smell can occur in pregnancy and are multifactorial
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Patients with poor or questionable compliance, as participation requires daily compliance with study protocol
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Patient's that are unable to perform routine follow-up
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Patients who are participating in another study during this trial
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Patients with dementia, Alzheimer's disease, Parkinson's disease, or other neurocognitive disorders, as these conditions are associated with baseline olfactory dysfunction.
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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
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Patients who are allergic to any of the smells or components of our olfactory testing and training
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
Sponsors and Collaborators
- University of Kansas Medical Center
Investigators
- Principal Investigator: Jennifer A Villwock, MD, University of Kansas Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00146529