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The purpose of this study is to determine the impact of a twice daily at-home olfactory training program with a twenty scent, essential oil-based smell test in patients with olfactory dysfunction.
This study randomizes participants to receive either a four scent or fourteen scent olfactory retraining protocol. Baseline olfaction will be tested with a currently commercially available smell test as well as an essential oil based smell test. The protocol involves twice daily retraining where the participant inhales the scent and makes a mental note of what they should be smelling. The training period is six months total with a visit at 3 months to re-assess smell function as well as at six months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: 15 Scents | Experimental | Participants will be asked to inhale 15 different scents two times a day. |
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| Group B: 4 Scents | Active Comparator | Participants will be asked to inhale 4 different scents two times a day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smell Test | Other | Oils are used for each of the different scents. Each scent will be put on an aromatherapy inhaling stick. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in ability to detect odorants - Sniffin' Sticks | Sniffin Sticks are a battery of 12 scents within a tube. The subject smells each scent and then chooses from 4 multiple choice options which is the scent they smelled. Increased number of correct responses indicates better sense of smell. 12/12 is the maximum score. 0/12 is the minimum score. | Change from Baseline to Month 6 |
| Change in ability to detect odorants - AROMA | AROMA is a essential oil based test. The subject is asked to respond if they detect a smell. If yes, they proceed to a 4 multiple choice items and select the item the smell. If no, they proceed to the next item. Higher number correct indicates better sense of smell. It consists of 13 odorants and 1 blank. Improved sense of smell would also increase the number of correctly identified odorants out of the 14 (including noting the 1 blank). | Change from Baseline to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) | The QOD-NS includes 17 statements that are graded on a scale from 0 to 3. Total score ranges from 0 to 51. Higher QOD-NS scores reflect better quality of life. | Change from Baseline to Month 6 |
| SF-12 (Short Form Health Survey) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Villwock, 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 |
|---|---|
| D000086582 | Anosmia |
| ID | Term |
|---|---|
| D000857 | Olfaction Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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SF-12 is a validated general measure of quality of life instrument that includes physical and mental scales. There are a total of 12 questions. Each aspect of the scale is weighted differently to yield a composite score. In general, a higher score is associated with better health. |
| Change from Baseline to Month 6 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |