Olfactory Training in Various Populations

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 Overview

• Status: Active, not recruiting
• Conditions: Traumatic Brain Injury; Concussion, Brain; Olfactory Disorder; Smell Disorder
• Intervention / Treatment: Other: Smell Test

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• history of traumatic brain injury
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: 4 scents; Participants will be asked to inhale 4 different scents 2 times a day.	Other: Smell Test; Oils are used for each of the different scents. Each scent is administered via an aromatherapy inhaling stick.
Active Comparator: Group B: 14 scents; Participants will be asked to inhale 14 different scents 2 times a day.	Other: Smell Test; Oils are used for each of the different scents. Each scent is administered via an aromatherapy inhaling stick.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Change from baseline to month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance with Olfactory Training Protocol	Self-reported tolerance with following olfactory training protocol	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)	Change from baseline to month 6

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Jennifer A Villwock, MD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2020
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Sensation Disorders; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Olfaction Disorders
• Other Study ID Numbers: STUDY00146529

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No