Olfactory DisorderNCT03611673
At-Home Olfactory Training
A study testing Smell Test in people with Olfactory Disorder, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Olfactory Disorder
- What is being tested?
- Smell Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2018to 19 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Have clinical olfactory dysfunction
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: At-Home Olfactory Training With Essential-Oil Based Scents
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.
Read the detailed description
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.
- Conditions
- Olfactory Disorder
- Being tested
- Smell Test
- Keywords
- sense of smell, smell test, at-home smell test, essential oil, olfactory loss
- Medical subject headings
- Anosmia
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 will be put on an aromatherapy inhaling stick.
| Study group | Role | What they receive |
|---|---|---|
| Group A: 15 Scents | Experimental | Participants will be asked to inhale 15 different scents two times a day. Receives: Other: Smell Test |
| Group B: 4 Scents | Active comparator | Participants will be asked to inhale 4 different scents two times a day. Receives: Other: Smell Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Change from Baseline to Month 6
Secondary outcomes (2)
Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS)
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.
Measured: Change from Baseline to Month 6
SF-12 (Short Form Health Survey)
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.
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 Aug 2018
- Study start2 Jun 2018
- Primary completion19 Apr 2021
- Study completion19 Apr 2021
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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Villwock, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611673
- Sponsor's protocol ID
- STUDY00141820
- Status last verified
- Jul 2023
- First submitted
- 5 Jun 2018
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- At-Home Olfactory Training With Essential-Oil Based Scents
- ClinicalTrials.gov ID
- NCT03611673
- Acronym / sponsor ID
- STUDY00141820
- Conditions
- Olfactory Disorder
- Keywords
- sense of smell, smell test, at-home smell test, essential oil, olfactory loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 2 Jun 2018 (actual)
- Primary completion
- 19 Apr 2021 (actual)
- Study completion
- 19 Apr 2021 (actual)
- First posted
- 2 Aug 2018 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: 15 Scents | Experimental | Other: Smell TestParticipants will be asked to inhale 15 different scents two times a day. |
| Group B: 4 Scents | Active comparator | Other: Smell TestParticipants will be asked to inhale 4 different scents two 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 (1 listed)
- Have clinical olfactory dysfunction
Key exclusion criteria (9 listed)
- 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
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 will be put on an aromatherapy inhaling stick. | Other | Group A: 15 Scents, Group B: 4 Scents |
Primary outcome
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.
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).
2 secondary outcomes
Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS)
Time frame: Change from Baseline to Month 6
SF-12 (Short Form Health Survey)
Time frame: Change from Baseline to Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
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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. This study is not recruiting at the moment.
Jennifer Villwock, 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, 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 1 inclusion and 9 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: finished, as of the sponsor's last update on 20 Jul 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in ability to detect odorants - Sniffin' Sticks (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 20 Jul 2023.