Olfactory Training in Various Populations

NCT ID: NCT06115291

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-13
• Study Completion Date: 2026-07-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A: 4 scents

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

Group Type: EXPERIMENTAL

Smell Test

Intervention Type: OTHER

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

Group B: 14 scents

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

Group Type: ACTIVE_COMPARATOR

Smell Test

Intervention Type: OTHER

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

Interventions

Smell Test

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Villwock

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer A Villwock, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

STUDY00146529

Identifier Type: -

Identifier Source: org_study_id