Skip to main content
OpenTrials
Completed

NCT Number: NCT03611673

At-Home Olfactory Training

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Olfactory Disorder Anosmia Nervous System Diseases Neurologic Manifestations Olfaction Disorders Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Smell Test

Other

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

Primary outcomes

  1. Change in ability to detect odorants - Sniffin' Sticks

    Time frame: 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.

  2. Change in ability to detect odorants - AROMA

    Time frame: 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 outcomes

  1. Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS)

    Time frame: 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.

  2. SF-12 (Short Form Health Survey)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

At-Home Olfactory Training With Essential-Oil Based Scents

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 2, 2018
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.