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Trial Title:
Chemosensory Dysfunction and Recovery in Endoscopic Endonasal Skull Base Surgery
NCT ID:
NCT05912881
Condition:
Anosmia
Skull Base Neoplasms
Conditions: Official terms:
Skull Base Neoplasms
Anosmia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Participants are enrolled into treatment or placebo groups for the entirety of the study.
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
All study team members and study participants are blinded as to which olfactory training
kit (treatment vs placebo) the participants received.
Intervention:
Intervention type:
Other
Intervention name:
Olfactory training
Description:
Participants perform olfactory training using sticks filled with scented essential oils.
Arm group label:
Treatment
Intervention type:
Other
Intervention name:
Placebo training
Description:
Participants perform olfactory training using sticks filled with unscented medium chain
triglycerides.
Arm group label:
Placebo
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Johns Hopkins Medicine
Address:
City:
Baltimore
Zip:
21224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nicholas R Rowan, MD
Phone:
410-955-2307
Email:
nrowan1@jhmi.edu
Contact backup:
Last name:
Michael Z Cheng, MD
Phone:
(443) 997-6467
Email:
mcheng31@jh.edu
Start date:
February 1, 2023
Completion date:
January 1, 2026
Lead sponsor:
Agency:
Johns Hopkins University
Agency class:
Other
Collaborator:
Agency:
North American Skull Base Society
Agency class:
Other
Source:
Johns Hopkins University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05912881
