- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03055572
Olfactory Training in Chronic Rhinosinusitis
Olfactory Training for Olfactory Dysfunction in Chronic Rhinosinusitis
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Olfactory Training with Essential Oils
Participants assigned to this group will do olfactory training using essential oils, while continuing the medical therapy prescribed by their provider.
|
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.
|
Active Comparator: Olfactory Training with Pure Fragrance Oils
Participants assigned to this group will do olfactory training using pure fragrance oils, while continuing the medical therapy prescribed by their provider.
|
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.
|
No Intervention: Control Group
The control group will continue the medical therapy prescribed by their provider.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, Week 12
|
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".
|
Baseline, Week 4, Week 8, and Week 12
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas Edwards, MD, Emory University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB00094289
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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