Olfactory DysfunctionNCT03055572
Olfactory Training in Chronic Rhinosinusitis
A study testing Olfactory Training with Essential Oils and Olfactory Training with Pure Fragrance Oils in people with Olfactory Dysfunction, run by Emory University.
Trial summary
Persons with a loss of sense of smell, who agree to participate in this study, will be assigned to one of three groups: two groups will have smell training and the third group will not do smell training. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Olfactory Dysfunction
- What is being tested?
- Olfactory Training with Essential Oils and Olfactory Training with Pure Fragrance Oils
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2019to 15 Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic rhinosinusitis (CRS) by consensus criteria from the International Consensus Statement on Allergy and Rhinology: Rhinosinusitis (ICAR:RS)
- Self-reports that decreased sense of smell/taste is moderate, severe, or as bad as it can be on the Sino-Nasal Outcome Test (SNOT)
- Trial of saline irrigations and topical nasal corticosteroids for >3 weeks
Who cannot join
- Diagnosis of cystic fibrosis, congenital anosmia, or neurocognitive disorder
- History of sinonasal tumor or anterior skull base resection
- Development of olfactory dysfunction (OD) immediately following facial trauma
About this study
Official title: Olfactory Training for Olfactory Dysfunction in Chronic Rhinosinusitis
Persons with a loss of sense of smell, who agree to participate in this study, will be assigned to one of three groups: two groups will have smell training and the third group will not do smell training. Participants assigned to one of the smell training groups will be asked to smell four different odors in rotation for five minutes two times per day, a total of 10 minutes of participation per day, for 12 weeks. One smell training group will be given odors made of fragrance oils to use for smell training. The other smell training group will be given odors made of essential oils to use. Participants in all groups will continue taking all medications and nasal rinses for sinusitis as prescribed by their doctor.
Read the detailed description
Problems with the ability to smell are referred to as olfactory dysfunction (OD). This condition is a widespread issue. 10-20% of all adults have OD, with 15 million individuals in the US self-reporting it in the past year. Chronic rhinosinusitis (CRS) is defined as 12 weeks or longer of non-clear nasal drainage, nasal congestion, facial pain or pressure, and/or decreased sense of smell. CRS is a common cause of OD. Up to 78% of patients with CRS reporting decreased sense of smell.
Several previous studies have shown a beneficial treatment option for OD called olfactory training (OT). OT consists of smelling different odors several times per day, every day for several months. These studies have shown that OT improves the sense of smell in patients who lost their sense of smell due to acute infection, head trauma, or diseases of the brain like Parkinson's disease. OT has not, however, been studied previously as a treatment for OD due to CRS.
The proposed study will use a randomized controlled trial to investigate if OT is effective for the treatment of OD in CRS. It will also investigate if widely available and lower cost odors, called essential oils, are as effective as traditionally used, pure fragrance oils, for OT in CRS. Lastly, the modified Questionnaire of Olfactory Disorders (mQOD) will be tested to determine if it can be used as a valid measure for monitoring patient's response to treatment.
Patients diagnosed with CRS who report that their sense of smell is diminished on a standard intake survey given to all patients will be recruited for the study by their treating practitioner. Once enrolled and consented, the subject will take the mQOD and then undergo a baseline Brief Smell Identification Test (BSIT) test. They will then be randomly assigned to one of three groups. The subjects in two groups (n = 50 subjects per group) will receive OT while the subjects in the third group (n = 50 subjects) will serve as a control group and will not receive OT. Subjects in the OT groups will be asked to smell four different odors in rotation for five minutes two times per day, a total of 10 minutes of participation per day. Half of the patients assigned to the OT group will be given odors made of fragrance oils. The other half will be given odors made of essential oils to use. Patients will be blinded to whether they were given fragrance oils or essential oils. Subjects in the OT groups will be asked to record each training session in a provided journal.
All subjects regardless of group will be sent an electronic version of the mQOD via email after the first and second month. Regardless of which group subjects are assigned, they will continue taking all medications and treatments for CRS as if they were not enrolled in this study. After three months, all subjects will again complete this survey as well as a second BSIT test. This study will determine if a) OT is an effective treatment for OD due to CRS, b) essential oils are as effective as pure fragrance oils for OT in CRS, and c) if the mQOD can be used to monitor treatments for OD in CRS.
- Conditions
- Olfactory Dysfunction
- Being tested
- Olfactory Training with Essential Oils, Olfactory Training with Pure Fragrance Oils
- Keywords
- Rhinitis, Chronic Rhinosinusitis, Olfactory Training
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olfactory Training with Essential OilsOther
Participants will be instructed to sniff one of four provided odors for approximately 10 seconds followed by a 10 second break before repeating with each successive odor for a total of 5 minutes. Essential oils will be used for the odors. The intervention will be completed in the morning before breakfast and in the evening before bed. Participants will document compliance by completing a log of olfactory training sessions.
Olfactory Training with Pure Fragrance OilsOther
Participants will be instructed to sniff one of four provided odors for approximately 10 seconds followed by a 10 second break before repeating with each successive odor for a total of 5 minutes. Pure fragrance oils will be used for the odors. The intervention will be completed in the morning before breakfast and in the evening before bed. Participants will document compliance by completing a log of olfactory training sessions.
| Study group | Role | What they receive |
|---|---|---|
| Olfactory Training with Essential Oils | Experimental | Participants assigned to this group will do olfactory training using essential oils, while continuing the medical therapy prescribed by their provider. Receives: Other: Olfactory Training with Essential Oils |
| Olfactory Training with Pure Fragrance Oils | Active comparator | Participants assigned to this group will do olfactory training using pure fragrance oils, while continuing the medical therapy prescribed by their provider. Receives: Other: Olfactory Training with Pure Fragrance Oils |
| Control Group | No intervention | The control group will continue the medical therapy prescribed by their provider. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Brief Smell Identification Test (BSIT)
The Brief Smell Identification Test (BSIT) is a 12-question scratch-n-sniff test to evaluate sense of smell. Score ranges from 0 to 12. Higher BSIT score indicate a better sense of smell. BSIT scores ≥ 9 is considered normal. Lower BSIT scores (≤ 8) indicate olfactory dysfunction. A change in BSIT by 1 is considered clinically significant.
Measured: Baseline, Week 12
Changes in modified Questionnaire of Olfactory Disorders (mQOD) score
The modified Questionnaire of Olfactory Disorders (mQOD) is a 17-item survey assessing quality of life in individuals with olfactory disorder. Respondents rate how much they agree with statements about how much their daily lives, social encounters, and feelings of safety are impacted by loss of smell by selecting "I agree" , "I agree partly", "I disagree partly" or "I disagree".
Measured: Baseline, Week 4, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start1 Mar 2019 (estimated)
- Primary completion15 Dec 2019 (estimated)
- Study completion15 Dec 2019 (estimated)
Why it stopped: Staffing issues resulted in the closure of the study prior to any participants being enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Olfactory DysfunctionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Model description
- Participants are randomized into one of three study arms: essential oil arm, pure fragrance oil arm, and control arm.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas S. Edwards, MD, Emory University
- Investigators
- Thomas Edwards, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055572
- Sponsor's protocol ID
- IRB00094289
- Status last verified
- May 2019
- First submitted
- 14 Feb 2017
- Last updated
- 30 May 2019
- 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 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olfactory Training for Olfactory Dysfunction in Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT03055572
- Acronym / sponsor ID
- IRB00094289
- Conditions
- Olfactory Dysfunction
- Keywords
- Rhinitis, Chronic Rhinosinusitis, Olfactory Training
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Staffing issues resulted in the closure of the study prior to any participants being enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 15 Dec 2019 (estimated)
- Study completion
- 15 Dec 2019 (estimated)
- First posted
- 16 Feb 2017 (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.
Persons with a loss of sense of smell, who agree to participate in this study, will be assigned to one of three groups: two groups will have smell training and the third group will not do smell training. Participants assigned to one of the smell training groups will be asked to smell four different odors in rotation for five minutes two times per day, a total of 10 minutes of participation per day, for 12 weeks. One smell training group will be given odors made of fragrance oils to use for smell training. The other smell training group will be given odors made of essential oils to use. Participants in all groups will continue taking all medications and nasal rinses for sinusitis as prescribed by their doctor.
Detailed description
Problems with the ability to smell are referred to as olfactory dysfunction (OD). This condition is a widespread issue. 10-20% of all adults have OD, with 15 million individuals in the US self-reporting it in the past year. Chronic rhinosinusitis (CRS) is defined as 12 weeks or longer of non-clear nasal drainage, nasal congestion, facial pain or pressure, and/or decreased sense of smell. CRS is a common cause of OD. Up to 78% of patients with CRS reporting decreased sense of smell.
Several previous studies have shown a beneficial treatment option for OD called olfactory training (OT). OT consists of smelling different odors several times per day, every day for several months. These studies have shown that OT improves the sense of smell in patients who lost their sense of smell due to acute infection, head trauma, or diseases of the brain like Parkinson's disease. OT has not, however, been studied previously as a treatment for OD due to CRS.
The proposed study will use a randomized controlled trial to investigate if OT is effective for the treatment of OD in CRS. It will also investigate if widely available and lower cost odors, called essential oils, are as effective as traditionally used, pure fragrance oils, for OT in CRS. Lastly, the modified Questionnaire of Olfactory Disorders (mQOD) will be tested to determine if it can be used as a valid measure for monitoring patient's response to treatment.
Patients diagnosed with CRS who report that their sense of smell is diminished on a standard intake survey given to all patients will be recruited for the study by their treating practitioner. Once enrolled and consented, the subject will take the mQOD and then undergo a baseline Brief Smell Identification Test (BSIT) test. They will then be randomly assigned to one of three groups. The subjects in two groups (n = 50 subjects per group) will receive OT while the subjects in the third group (n = 50 subjects) will serve as a control group and will not receive OT. Subjects in the OT groups will be asked to smell four different odors in rotation for five minutes two times per day, a total of 10 minutes of participation per day. Half of the patients assigned to the OT group will be given odors made of fragrance oils. The other half will be given odors made of essential oils to use. Patients will be blinded to whether they were given fragrance oils or essential oils. Subjects in the OT groups will be asked to record each training session in a provided journal.
All subjects regardless of group will be sent an electronic version of the mQOD via email after the first and second month. Regardless of which group subjects are assigned, they will continue taking all medications and treatments for CRS as if they were not enrolled in this study. After three months, all subjects will again complete this survey as well as a second BSIT test. This study will determine if a) OT is an effective treatment for OD due to CRS, b) essential oils are as effective as pure fragrance oils for OT in CRS, and c) if the mQOD can be used to monitor treatments for OD in CRS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants are randomized into one of three study arms: essential oil arm, pure fragrance oil arm, and control arm.
| Arm | Type | Receives |
|---|---|---|
| Olfactory Training with Essential Oils | Experimental | Other: Olfactory Training with Essential OilsParticipants assigned to this group will do olfactory training using essential oils, while continuing the medical therapy prescribed by their provider. |
| Olfactory Training with Pure Fragrance Oils | Active comparator | Other: Olfactory Training with Pure Fragrance OilsParticipants assigned to this group will do olfactory training using pure fragrance oils, while continuing the medical therapy prescribed by their provider. |
| Control Group | No intervention | –The control group will continue the medical therapy prescribed by their provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of chronic rhinosinusitis (CRS) by consensus criteria from the International Consensus Statement on Allergy and Rhinology: Rhinosinusitis (ICAR:RS)
- Self-reports that decreased sense of smell/taste is moderate, severe, or as bad as it can be on the Sino-Nasal Outcome Test (SNOT)
- Trial of saline irrigations and topical nasal corticosteroids for >3 weeks
Key exclusion criteria (3 listed)
- Diagnosis of cystic fibrosis, congenital anosmia, or neurocognitive disorder
- History of sinonasal tumor or anterior skull base resection
- Development of olfactory dysfunction (OD) immediately following facial trauma
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 |
|---|---|---|
| Olfactory Training with Essential OilsParticipants will be instructed to sniff one of four provided odors for approximately 10 seconds followed by a 10 second break before repeating with each successive odor for a total of 5 minutes. Essential oils will be used for the odors. The intervention will be completed in the morning before breakfast and in the evening before bed. Participants will document compliance by completing a log of olfactory training sessions. | Other | Olfactory Training with Essential Oils |
| Olfactory Training with Pure Fragrance OilsParticipants will be instructed to sniff one of four provided odors for approximately 10 seconds followed by a 10 second break before repeating with each successive odor for a total of 5 minutes. Pure fragrance oils will be used for the odors. The intervention will be completed in the morning before breakfast and in the evening before bed. Participants will document compliance by completing a log of olfactory training sessions. | Other | Olfactory Training with Pure Fragrance Oils |
Primary outcome
Changes in Brief Smell Identification Test (BSIT)
Time frame: Baseline, Week 12
The Brief Smell Identification Test (BSIT) is a 12-question scratch-n-sniff test to evaluate sense of smell. Score ranges from 0 to 12. Higher BSIT score indicate a better sense of smell. BSIT scores ≥ 9 is considered normal. Lower BSIT scores (≤ 8) indicate olfactory dysfunction. A change in BSIT by 1 is considered clinically significant.
Changes in modified Questionnaire of Olfactory Disorders (mQOD) score
Time frame: Baseline, Week 4, Week 8, and Week 12
The modified Questionnaire of Olfactory Disorders (mQOD) is a 17-item survey assessing quality of life in individuals with olfactory disorder. Respondents rate how much they agree with statements about how much their daily lives, social encounters, and feelings of safety are impacted by loss of smell by selecting "I agree" , "I agree partly", "I disagree partly" or "I disagree".
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Individual participant dataSharing planned: No
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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.
Thomas Edwards, MD principal investigator
Emory University
Questions about this trial
What is this clinical trial studying?
A study testing Olfactory Training with Essential Oils and Olfactory Training with Pure Fragrance Oils in people with Olfactory Dysfunction, run by Emory University.
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 3 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: withdrawn, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Changes in Brief Smell Identification Test (BSIT) (time frame: Baseline, Week 12). 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 30 May 2019.