Olfactory Training in Various Populations

University of Kansas

Status: Invitation-only

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

Treatments: Other: Smell Test

Study type: Interventional

Funder types: Other

Identifiers

NCT06115291

STUDY00146529

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Group A: 4 scents

Experimental group

Description:

Participants will be asked to inhale 4 different scents 2 times a day.

Treatment:

Other: Smell Test

Group B: 14 scents

Active Comparator group

Description:

Participants will be asked to inhale 14 different scents 2 times a day.

Treatment:

Other: Smell Test