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Chemosensory Dysfunction and Recovery in Endoscopic Endonasal Skull Base Surgery

Primary Purpose

Anosmia, Skull Base Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Olfactory training
Placebo training
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anosmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Johns Hopkins MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
June 2, 2023
Last Updated
June 20, 2023
Sponsor
Johns Hopkins University
Collaborators
North American Skull Base Society
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1. Study Identification

Unique Protocol Identification Number
NCT05912881
Brief Title
Chemosensory Dysfunction and Recovery in Endoscopic Endonasal Skull Base Surgery
Official Title
Chemosensory Dysfunction and Recovery in Endoscopic Endonasal Skull Base Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
North American Skull Base Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anosmia, Skull Base Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are enrolled into treatment or placebo groups for the entirety of the study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All study team members and study participants are blinded as to which olfactory training kit (treatment vs placebo) the participants received.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo olfactory training kits that only contain medium chain triglycerides that lack any discernible odor
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Participants receive treatment olfactory training kits that contain essential oils that have scents (lavender, lemon, clove, eucalyptus)
Intervention Type
Other
Intervention Name(s)
Olfactory training
Intervention Description
Participants perform olfactory training using sticks filled with scented essential oils.
Intervention Type
Other
Intervention Name(s)
Placebo training
Intervention Description
Participants perform olfactory training using sticks filled with unscented medium chain triglycerides.
Primary Outcome Measure Information:
Title
Change in Olfactory function as assessed by the Sniffin Sticks olfactory testing kit
Description
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.
Time Frame
Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative
Secondary Outcome Measure Information:
Title
Change in Quality of Life as assessed by the Anterior Skull Base Nasal Inventory-12
Description
Quality of life questionnaire. Score range 0-60, where higher score is worse and indicates more onerous symptoms.
Time Frame
Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative
Title
Change in Quality of Life as assessed by the ODOR (Olfactory Dysfunction Outcomes Rating) questionnaire
Description
Quality of life questionnaire. Score range 0-112, where higher score is worse and indicates greater degree of olfactory dysfunction.
Time Frame
Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative
Title
Change in Quality of Life as assessed by the Skull Base Inventory
Description
Quality of life questionnaire. Score range 0-100, where higher score is better, indicative of less burden on quality of life.
Time Frame
Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative
Title
Change in Quality of smell and taste as assessed by a Visual analog scale
Description
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.
Time Frame
Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Cheng, MD
Phone
(443)997-6467
Email
mcheng31@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Rowan, MD
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas R Rowan, MD
Phone
410-955-2307
Email
nrowan1@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Michael Z Cheng, MD
Phone
(443) 997-6467
Email
mcheng31@jh.edu

12. IPD Sharing Statement

Learn more about this trial

Chemosensory Dysfunction and Recovery in Endoscopic Endonasal Skull Base Surgery

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