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Enrolling by invitation NCT06115291

Olfactory Training in Various Populations

No phase Interventional Olfactory Disorder Smell Disorder Traumatic Brain Injury Concussion, Brain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Smell Test.
Who it may be relevant to
Registry conditions: Olfactory Disorder, Smell Disorder, Traumatic Brain Injury, Concussion, Brain. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

To date, there is no validated pharmacotherapy for olfactory disorders. Interestingly, olfactory training - the intentional exposure to odorants for the purposes of retraining the sense of smell - has shown success with as many as 28% of subjects over the course of 12 weeks.

Detailed description

Study Objectives: The overall, primary goals of these studies are as follows:

1. To compare the outcomes of our olfactory testing battery for olfactory training to the previously published literature 2. To determine if using a larger panel of odorants (our 15 scents versus the 4 scents previously used in the literature) yields a significant difference in olfactory recovery.

Interventions

  • Other Smell Test
    Oils are used for each of the different scents. Each scent is administered via an aromatherapy inhaling stick.

Primary outcome measures

  • Olfactory Threshold [Time frame: Change from baseline to month 6]
  • Olfactory Identification [Time frame: Change from baseline to month 6]
Secondary outcome measures (2)
  • Tolerance with Olfactory Training Protocol [Time frame: At follow-up visits]
  • Neurocognition [Time frame: Change from baseline to month 6]

Eligibility criteria

Inclusion criteria

  • Age 18-80
  • Quantifiable or subjective olfactory dysfunction
  • ability to complete objective olfactory tests and comply with olfactory training protocol

Exclusion criteria

  • Anyone lower than the age of 18, or greater than the age of 80
  • Pregnant women, as sinonasal symptoms and changes in smell can occur in pregnancy and are multifactorial
  • Patients with poor or questionable compliance, as participation requires daily compliance with study protocol
  • Patient's that are unable to perform routine follow-up
  • Patients who are participating in another study during this trial
  • Patients with dementia, Alzheimer's disease, Parkinson's disease, or other neurocognitive disorders, as these conditions are associated with baseline olfactory dysfunction.
  • Patients with other systemic conditions known to impact the sinonasal cavity such as Wegener's granulomatosis, Churg Strauss, and immunodeficiency, as their impact on olfaction is unknown
  • Patients who are allergic to any of the smells or components of our olfactory testing and training

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Kansas Medical Center — Kansas City

Identifiers

NCT: NCT06115291 · STUDY00146529

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗