Olfactory Training in Various Populations

Traumatic Brain Injury Clinical Trial

Official title:

Olfactory Training in Various Populations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06115291
• Other study ID #: STUDY00146529
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 13, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Concussion, Brain
• Olfaction Disorders
• Olfactory Disorder
• Smell Disorder
• Traumatic Brain Injury

Intervention

Other:
• Smell Test
Oils are used for each of the different scents. Each scent is administered via an aromatherapy inhaling stick.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Tolerance with Olfactory Training Protocol	Self-reported tolerance with following olfactory training protocol	At follow-up visits
Secondary	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