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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05912881
Other study ID # IRB00311777
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date January 1, 2026

Study information

Verified date June 2024
Source Johns Hopkins University
Contact Michael Cheng, MD
Phone (443)997-6467
Email mcheng31@jhmi.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date January 1, 2026
Est. primary completion date January 1, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Olfactory training
Participants perform olfactory training using sticks filled with scented essential oils.
Placebo training
Participants perform olfactory training using sticks filled with unscented medium chain triglycerides.

Locations

Country Name City State
United States Johns Hopkins Medicine Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University North American Skull Base Society

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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