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| Name | Class |
|---|---|
| North American Skull Base Society | OTHER |
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The investigators hypothesize that patients undergoing endoscopic endonasal skull base surgery experience clinically meaningful and modifiable disruptions in postoperative chemosensory function and quality of life, and the investigators further hypothesize that olfactory training in the postoperative period may significantly hasten normalization of patients' chemosensory perturbations. This tailored prospective study seeks to fulfill a significant gap in the understanding of the characteristics, implications, and treatment options for postoperative olfactory and gustatory impairment following endoscopic endonasal skull base surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants receive placebo olfactory training kits that only contain medium chain triglycerides that lack any discernible odor |
|
| Treatment | Experimental | Participants receive treatment olfactory training kits that contain essential oils that have scents (lavender, lemon, clove, eucalyptus) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olfactory training | Other | Participants perform olfactory training using sticks filled with scented essential oils. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Olfactory function as assessed by the Sniffin Sticks olfactory testing kit | Olfactory function as determined using the commercially available "Sniffin' Sticks" olfactory testing kit. Olfactory function is tested in three domains: threshold, discrimination, and identification. For threshold testing, the most dilute concentration of odorant that the participant is able to reliably detect is determined. In discrimination testing, the participant is evaluated on their ability to discern the unique scent among three scented sticks. In identification testing, the patient names the smells using a multiple choice form which offers four definitions for every Sniffin' stick, only one of which is correct. | Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life as assessed by the Anterior Skull Base Nasal Inventory-12 | Quality of life questionnaire. Score range 0-60, where higher score is worse and indicates more onerous symptoms. | Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Rowan, MD | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Medicine | Baltimore | Maryland | 21224 | United States |
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| ID | Term |
|---|---|
| D000086582 | Anosmia |
| D019292 | Skull Base Neoplasms |
| ID | Term |
|---|---|
| D000857 | Olfaction Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000094562 | Olfactory Training |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Participants are enrolled into treatment or placebo groups for the entirety of the study.
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All study team members and study participants are blinded as to which olfactory training kit (treatment vs placebo) the participants received.
| Placebo training | Other | Participants perform olfactory training using sticks filled with unscented medium chain triglycerides. |
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| Change in Quality of Life as assessed by the ODOR (Olfactory Dysfunction Outcomes Rating) questionnaire |
Quality of life questionnaire. Score range 0-112, where higher score is worse and indicates greater degree of olfactory dysfunction. |
| Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative |
| Change in Quality of Life as assessed by the Skull Base Inventory | Quality of life questionnaire. Score range 0-100, where higher score is better, indicative of less burden on quality of life. | Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative |
| Change in Quality of smell and taste as assessed by a Visual analog scale | Quality of smell and taste as indicated on a visual analog scale. Score range 0-100, where higher score is better and indicative of better smell and taste function. | Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012888 | Skull Neoplasms |
| D001859 | Bone Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |