Chemosensory Dysfunction and Recovery in Endoscopic Endonasal Skull Base Surgery

Anosmia Clinical Trial

Official title:

Chemosensory Dysfunction and Recovery in Endoscopic Endonasal Skull Base Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05912881
• Other study ID #: IRB00311777
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: June 2023
• Source: Johns Hopkins University
• Contact: Michael Cheng, MD
• Phone: (443)997-6467
• Email: mcheng31[@]jhmi.edu
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Anosmia
• Skull Base Neoplasms

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