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Completed

NCT Number: NCT05912881

Chemosensory Dysfunction and Recovery in Endoscopic Endonasal Skull Base Surgery

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Medicine

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olfactory Training

Other

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

Placebo Training

Other

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

Primary outcomes

  1. Change in Olfactory function as assessed by the Sniffin Sticks olfactory testing kit

    Time frame: 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 outcomes

  1. Change in Quality of Life as assessed by the Anterior Skull Base Nasal Inventory-12

    Time frame: 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.

  2. Change in Quality of Life as assessed by the ODOR (Olfactory Dysfunction Outcomes Rating) questionnaire

    Time frame: 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.

  3. Change in Quality of Life as assessed by the Skull Base Inventory

    Time frame: 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.

  4. Change in Quality of smell and taste as assessed by a Visual analog scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • North American Skull Base Society

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2023
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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