At-Home Olfactory Training

NCT03611673 | Completed

• 1 other identifier: STUDY00141820
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Olfactory Disorder

Keywords

sense of smell; smell test; at-home smell test; essential oil; olfactory loss

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS)

  Change from Baseline to Month 6

• SF-12 (Short Form Health Survey)

  Change from Baseline to Month 6

Study Arms (2)

Group A: 15 Scents

EXPERIMENTAL

Participants will be asked to inhale 15 different scents two times a day.

Other: Smell Test

Group B: 4 Scents

ACTIVE COMPARATOR

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

Other: Smell Test

Interventions

Smell Test OTHER

Oils are used for each of the different scents. Each scent will be put on an aromatherapy inhaling stick.

Group A: 15 Scents; Group B: 4 Scents

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have clinical olfactory dysfunction

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Anosmia

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Villwock, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: August 2, 2018
• Study Start: June 2, 2018
• Primary Completion: April 19, 2021
• Study Completion: April 19, 2021
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

US (1)