Chemosensory Dysfunction and Recovery in Endoscopic Endonasal Skull Base Surgery

Johns Hopkins University

Status: Active, not recruiting

Conditions: Skull Base Neoplasms; Anosmia

Treatments: Other: Placebo training; Other: Olfactory training

Study type: Interventional

Funder types: Other

Identifiers

NCT05912881

IRB00311777

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo training

Treatment

Experimental group

Description:

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

Treatment:

Other: Olfactory training