At-Home Olfactory Training

Sponsor

University of Kansas Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT03611673

Collaborator

(none)

140

Enrollment

Location

Arms

45.9

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Olfactory Disorder	Other: Smell Test	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

At-Home Olfactory Training With Essential-Oil Based Scents

Actual Study Start Date :

Jun 2, 2018

Anticipated Primary Completion Date :

Dec 30, 2021

Anticipated Study Completion Date :

Mar 30, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in ability to detect odorants - Sniffin' Sticks [Change from Baseline to Month 6]
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 in ability to detect odorants - AROMA [Change from Baseline to Month 6]
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).

Secondary Outcome Measures

Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) [Change from Baseline to Month 6]
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.
SF-12 (Short Form Health Survey) [Change from Baseline to Month 6]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

University of Kansas Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Kansas Medical Center

ClinicalTrials.gov Identifier:

NCT03611673

Other Study ID Numbers:

STUDY00141820

First Posted:

Aug 2, 2018

Last Update Posted:

Jul 17, 2019

Last Verified:

Jul 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Kansas Medical Center

Study Results

No Results Posted as of Jul 17, 2019