Olfactory Training in Various Populations

N/AEnrolling By InvitationNCT06115291

University of Kansas Medical Center250 enrolled

Overview

To date, there is no validated pharmacotherapy for olfactory disorders. Interestingly, olfactory training - the intentional exposure to odorants for the purposes of retraining the sense of smell - has shown success with as many as 28% of subjects over the course of 12 weeks.

Study Objectives: The overall, primary goals of these studies are as follows: 1. To compare the outcomes of our olfactory testing battery for olfactory training to the previously published literature 2. To determine if using a larger panel of odorants (our 15 scents versus the 4 scents previously used in the literature) yields a significant difference in olfactory recovery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

250

Conditions

Olfactory Disorder Smell Disorder Traumatic Brain Injury Concussion, Brain

Interventions

Smell TestOTHER

Oils are used for each of the different scents. Each scent is administered via an aromatherapy inhaling stick.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-80 * Quantifiable or subjective olfactory dysfunction * ability to complete objective olfactory tests and comply with olfactory training protocol Exclusion Criteria: * Anyone lower than the age of 18, or greater than the age of 80 * Pregnant women, as sinonasal symptoms and changes in smell can occur in pregnancy and are multifactorial * Patients with poor or questionable compliance, as participation requires daily compliance with study protocol * Patient's that are unable to perform routine follow-up * Patients who are participating in another study during this trial * Patients with dementia, Alzheimer's disease, Parkinson's disease, or other neurocognitive disorders, as these conditions are associated with baseline olfactory dysfunction. * Patients with other systemic conditions known to impact the sinonasal cavity such as Wegener's granulomatosis, Churg Strauss, and immunodeficiency, as their impact on olfaction is unknown * Patients who are allergic to any of the smells or components of our olfactory testing and training

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

Olfactory Threshold

Changes in olfactory threshold when comparing pre- and post-olfactory training for performance in terms of percent correct per specific scent and overall combination of percent correct for all tested scents

Time frame: Change from baseline to month 6

Olfactory Identification

Changes in ability to detect and identify scents when comparing pre- and post-olfactory training for percent detected per individual scents and as a composite score reflecting performance on all scents

Time frame: Change from baseline to month 6

Secondary Outcomes

Tolerance with Olfactory Training Protocol

Self-reported tolerance with following olfactory training protocol

Time frame: At follow-up visits

Neurocognition

Assessment of neurocognition and impact on olfactory quality of life using the Mini-Mental Status Exam (MMSE) and Montreal Cognitive Assessment (MoCA)

Time frame: Change from baseline to month 6

Data from ClinicalTrials.gov

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