Chemosensory Dysfunction and Recovery in Endoscopic Endonasal Skull Base Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2026-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Olfactory Training in Various Populations

NCT06115291

Olfactory Disorder Smell Disorder Traumatic Brain Injury +1 more

ENROLLING_BY_INVITATION NA

At-Home Olfactory Training

NCT03611673

Olfactory Disorder

COMPLETED NA

Does Olfactory Training Improve Olfaction in a Population With Normal Sense of Smell?

NCT02980718

People With Normal Sense of Smell

COMPLETED NA

Treatment of Postviral Olfactory Dysfunction

NCT06142565

Hyposmia

COMPLETED NA

Olfactory Decision-making and Deprived Sleep

NCT05093413

Sleep Deprivation

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anosmia Skull Base Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

All study team members and study participants are blinded as to which olfactory training kit (treatment vs placebo) the participants received.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo training

Intervention Type OTHER

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

Treatment

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

Group Type EXPERIMENTAL

Olfactory training

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Olfactory training

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

Intervention Type OTHER

Placebo training

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes