Anosmia, Skull Base Neoplasms
Conditions
Brief summary
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.
Interventions
OTHEROlfactory training
Participants perform olfactory training using sticks filled with scented essential oils.
OTHERPlacebo training
Participants perform olfactory training using sticks filled with unscented medium chain triglycerides.
Sponsors
Johns Hopkins University
North American Skull Base Society
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All study team members and study participants are blinded as to which olfactory training kit (treatment vs placebo) the participants received.
Intervention model description
Participants are enrolled into treatment or placebo groups for the entirety of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* English Speaking * preoperative diagnosis of benign sellar or parasellar skull base pathology
Exclusion criteria
* preoperative diagnosis of malignant sellar or parasellar skull base pathology * history of endoscopic sinus surgery * history of skull base surgery * history of radiation therapy or other local treatments for the management of facial, sinonasal, or cranial pathologies * history of chronic rhinosinusitis * history of neurocognitive disorder * history of intrinsic chemosensory pathology * history of cardiac pacemaker * history of gastrectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Olfactory function as assessed by the Sniffin Sticks olfactory testing kit | Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life as assessed by the Anterior Skull Base Nasal Inventory-12 | Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative | Quality of life questionnaire. Score range 0-60, where higher score is worse and indicates more onerous symptoms. |
| Change in Quality of Life as assessed by the ODOR (Olfactory Dysfunction Outcomes Rating) questionnaire | Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative | Quality of life questionnaire. Score range 0-112, where higher score is worse and indicates greater degree of olfactory dysfunction. |
| Change in Quality of Life as assessed by the Skull Base Inventory | Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative | Quality of life questionnaire. Score range 0-100, where higher score is better, indicative of less burden on quality of life. |
| Change in Quality of smell and taste as assessed by a Visual analog scale | Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNicholas Rowan, MD
Johns Hopkins School of Medicine
Outcome results
None listed