Olfactory Training in Various Populations

Not Applicable

• Conditions: Smell Disorder; Concussion, Brain; Olfactory Disorder; Traumatic Brain Injury

• Registration Number: NCT06115291
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2020-02-13
• Study First Submitted: 2020-02-13
• Study First Submitted QC: 2023-10-30
• Study First Posted: 2023-11-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-20
• Primary Completion: 2025-12-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Olfactory Threshold	Change from baseline to month 6	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
Olfactory Identification	Change from baseline to month 6	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

Secondary Outcome Measures

Name	Time	Method
Neurocognition	Change from baseline to month 6	Assessment of neurocognition and impact on olfactory quality of life using the Mini-Mental Status Exam (MMSE) and Montreal Cognitive Assessment (MoCA)
Tolerance with Olfactory Training Protocol	At follow-up visits	Self-reported tolerance with following olfactory training protocol

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States