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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.
Study Objectives: The overall, primary goals of these studies are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: 4 scents | Experimental | Participants will be asked to inhale 4 different scents 2 times a day. |
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| Group B: 14 scents | Active Comparator | Participants will be asked to inhale 14 different scents 2 times a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smell Test | Other | Oils are used for each of the different scents. Each scent is administered via an aromatherapy inhaling stick. |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald D Beahm, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Term |
|---|---|
| D000857 | Olfaction Disorders |
| D000070642 | Brain Injuries, Traumatic |
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| Change from baseline to month 6 |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |