At-Home Olfactory Training

Olfactory Disorder Clinical Trial

Official title:

At-Home Olfactory Training With Essential-Oil Based Scents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611673
• Other study ID #: STUDY00141820
• Status: Completed
• Phase: N/A
• Start date: June 2, 2018
• Est. completion date: April 19, 2021

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 19, 2021
• Est. primary completion date: April 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Olfactory Disorder

Intervention

Other:
• Smell Test
Oils are used for each of the different scents. Each scent will be put on 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	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
Primary	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	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
Secondary	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