NCT06115291

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Feb 2020Jul 2026

First Submitted

Initial submission to the registry

February 13, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

February 13, 2020

Completed
3.7 years until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

5.9 years

First QC Date

February 13, 2020

Last Update Submit

July 23, 2025

Conditions

Olfactory DisorderSmell DisorderTraumatic Brain InjuryConcussion, Brain

Outcome Measures

Primary Outcomes (2)

  • Olfactory Threshold

    Changes in olfactory threshold when comparing pre- and post-olfactory training for performance in terms of percent correct per specific scent and overall combination of percent correct for all tested scents

    Change from baseline to month 6

  • Olfactory Identification

    Changes in ability to detect and identify scents when comparing pre- and post-olfactory training for percent detected per individual scents and as a composite score reflecting performance on all scents

    Change from baseline to month 6

Secondary Outcomes (2)

  • Tolerance with Olfactory Training Protocol

    At follow-up visits

  • Neurocognition

    Change from baseline to month 6

Study Arms (2)

Group A: 4 scents

EXPERIMENTAL

Participants will be asked to inhale 4 different scents 2 times a day.

Other: Smell Test

Group B: 14 scents

ACTIVE COMPARATOR

Participants will be asked to inhale 14 different scents 2 times a day.

Other: Smell Test

Interventions

Smell TestOTHER

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

Group A: 4 scentsGroup B: 14 scents

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Olfaction DisordersBrain Injuries, TraumaticBrain Concussion

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain InjuriesBrain DiseasesCentral Nervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesHead Injuries, ClosedWounds, Nonpenetrating

Study Officials

  • Jennifer A 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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 13, 2020

First Posted

November 2, 2023

Study Start

February 13, 2020

Primary Completion

December 31, 2025

Study Completion (Estimated)

July 31, 2026

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)