Olfactory DisorderNCT06115291
Olfactory Training in Various Populations
A study testing Smell Test in people with Olfactory Disorder and Smell Disorder, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Olfactory Disorder, Smell Disorder, Traumatic Brain Injury
- What is being tested?
- Smell Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2020to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80
- Quantifiable or subjective olfactory dysfunction
- ability to complete objective olfactory tests and comply with olfactory training protocol
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
Read the detailed description
Study Objectives: The overall, primary goals of these studies are as follows:
- To compare the outcomes of our olfactory testing battery for olfactory training to the previously published literature
- 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.
- Being tested
- Smell Test
- Medical subject headings
- Olfaction Disorders, Brain Injuries, Traumatic, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smell TestOther
Oils are used for each of the different scents. Each scent is administered via an aromatherapy inhaling stick.
| Study group | Role | What they receive |
|---|---|---|
| Group A: 4 scents | Experimental | Participants will be asked to inhale 4 different scents 2 times a day. Receives: Other: Smell Test |
| Group B: 14 scents | Active comparator | Participants will be asked to inhale 14 different scents 2 times a day. Receives: Other: Smell Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Change from baseline to month 6
Secondary outcomes (2)
Tolerance with Olfactory Training Protocol
Self-reported tolerance with following olfactory training protocol
Measured: At follow-up visits
Neurocognition
Assessment of neurocognition and impact on olfactory quality of life using the Mini-Mental Status Exam (MMSE) and Montreal Cognitive Assessment (MoCA)
Measured: Change from baseline to month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start13 Feb 2020
- Primary completion31 May 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Olfactory DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Beahm, MD, University of Kansas Medical Center
- Investigators
- Donald D Beahm, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115291
- Sponsor's protocol ID
- STUDY00146529
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 2020
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olfactory Training in Various Populations
- ClinicalTrials.gov ID
- NCT06115291
- Acronym / sponsor ID
- STUDY00146529
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To compare the outcomes of our olfactory testing battery for olfactory training to the previously published literature
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: 4 scents | Experimental | Other: Smell TestParticipants will be asked to inhale 4 different scents 2 times a day. |
| Group B: 14 scents | Active comparator | Other: Smell TestParticipants will be asked to inhale 14 different scents 2 times a day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80
- Quantifiable or subjective olfactory dysfunction
- ability to complete objective olfactory tests and comply with olfactory training protocol
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smell TestOils are used for each of the different scents. Each scent is administered via an aromatherapy inhaling stick. | Other | Group A: 4 scents, Group B: 14 scents |
Primary outcome
Olfactory Threshold
Time frame: Change from baseline to month 6
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
Olfactory Identification
Time frame: Change from baseline to month 6
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
2 secondary outcomes
Tolerance with Olfactory Training Protocol
Time frame: At follow-up visits
Neurocognition
Time frame: Change from baseline to month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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RecruitingObservational study
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Olfactory Cell Transplantation and Intensive Rehabilitation to Repair Chronic Spinal Cord Injury
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Donald D Beahm, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smell Test in people with Olfactory Disorder and Smell Disorder, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Olfactory Threshold (time frame: Change from baseline to month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.