At-Home Olfactory Training

At-Home Olfactory Training With Essential-Oil Based Scents

The purpose of this study is to determine the impact of a twice daily at-home olfactory training program with a twenty scent, essential oil-based smell test in patients with olfactory dysfunction.

Study Overview

• Status: Completed
• Conditions: Olfactory Disorder
• Intervention / Treatment: Other: Smell Test

Detailed Description

This study randomizes participants to receive either a four scent or fourteen scent olfactory retraining protocol. Baseline olfaction will be tested with a currently commercially available smell test as well as an essential oil based smell test. The protocol involves twice daily retraining where the participant inhales the scent and makes a mental note of what they should be smelling. The training period is six months total with a visit at 3 months to re-assess smell function as well as at six months.

• Study Type: Interventional
• Enrollment (Actual): 70
• 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: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have clinical olfactory dysfunction

Exclusion Criteria:

• Pregnant women
• Unable to perform routine follow-up
• Current participation in another clinical trial during this trial
• Patients with dementia, Alzheimer's disease, Parkinson's disease, or other neurocognitive disorders
• Diagnosis of other systemic conditions known to impact the sinonasal cavity such as Wegener's granulomatosis, Churg Strauss, and immunodeficiency
• Patients who are allergic to any of the smells or components of our olfactory testing
• Chronic rhinosinusitis, malignant tumors and/or oncologic therapies (radiation/chemotherapy)
• History of surgery on the nose or paranasal sinuses
• Patients using medications that may impact olfactory function (i.e. corticosteroids)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: 15 Scents; Participants will be asked to inhale 15 different scents two times a day.	Other: Smell Test; Oils are used for each of the different scents. Each scent will be put on an aromatherapy inhaling stick.
Active Comparator: Group B: 4 Scents; Participants will be asked to inhale 4 different scents two times a day.	Other: Smell Test; Oils are used for each of the different scents. Each scent will be put on an aromatherapy inhaling stick.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ability to detect odorants - Sniffin' Sticks	Sniffin Sticks are a battery of 12 scents within a tube. The subject smells each scent and then chooses from 4 multiple choice options which is the scent they smelled. Increased number of correct responses indicates better sense of smell. 12/12 is the maximum score. 0/12 is the minimum score.	Change from Baseline to Month 6
Change in ability to detect odorants - AROMA	AROMA is a essential oil based test. The subject is asked to respond if they detect a smell. If yes, they proceed to a 4 multiple choice items and select the item the smell. If no, they proceed to the next item. Higher number correct indicates better sense of smell. It consists of 13 odorants and 1 blank. Improved sense of smell would also increase the number of correctly identified odorants out of the 14 (including noting the 1 blank).	Change from Baseline to Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS)	The QOD-NS includes 17 statements that are graded on a scale from 0 to 3. Total score ranges from 0 to 51. Higher QOD-NS scores reflect better quality of life.	Change from Baseline to Month 6
SF-12 (Short Form Health Survey)	SF-12 is a validated general measure of quality of life instrument that includes physical and mental scales. There are a total of 12 questions. Each aspect of the scale is weighted differently to yield a composite score. In general, a higher score is associated with better health.	Change from Baseline to Month 6

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2018
• Primary Completion (Actual): April 19, 2021
• Study Completion (Actual): April 19, 2021

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: July 25, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: olfactory loss; essential oil; sense of smell; smell test; at-home smell test
• Other Study ID Numbers: STUDY00141820

Drug and device information, study documents

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