Chemosensory Dysfunction and Recovery in Endoscopic Endonasal Skull Base Surgery

NCT05912881 | Completed

• 1 other identifier: IRB00311777
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Anosmia; Skull Base Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants receive placebo olfactory training kits that only contain medium chain triglycerides that lack any discernible odor

Other: Placebo training

Treatment

EXPERIMENTAL

Participants receive treatment olfactory training kits that contain essential oils that have scents (lavender, lemon, clove, eucalyptus)

Other: Olfactory training

Interventions

Olfactory training OTHER

Participants perform olfactory training using sticks filled with scented essential oils.

Treatment

Placebo training OTHER

Participants perform olfactory training using sticks filled with unscented medium chain triglycerides.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English Speaking
• preoperative diagnosis of benign sellar or parasellar skull base pathology

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• North American Skull Base Society: collaborator

Study Sites (1)

Johns Hopkins Medicine

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Anosmia; Skull Base Neoplasms

Interventions

Olfactory Training

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skull Neoplasms; Bone Neoplasms; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Nicholas Rowan, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All study team members and study participants are blinded as to which olfactory training kit (treatment vs placebo) the participants received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are enrolled into treatment or placebo groups for the entirety of the study.

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 22, 2023
• Study Start: February 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (1)