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Olfactory Training in Chronic Rhinosinusitis

This study is not yet open for participant recruitment.
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Verified February 2017 by Thomas S. Edwards, MD, Emory University
Sponsor:
Information provided by (Responsible Party):
Thomas S. Edwards, MD, Emory University
ClinicalTrials.gov Identifier:
NCT03055572
First received: February 14, 2017
Last updated: NA
Last verified: February 2017
History: No changes posted
  Purpose
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.

Condition Intervention
Olfactory Dysfunction Other: Olfactory Training with Essential Oils Other: Olfactory Training with Pure Fragrance Oils

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants are randomized into one of three study arms: essential oil arm, pure fragrance oil arm, and control arm.
Masking: Single (Participant)
Masking Description:
Participants assigned to the either of the olfactory training arms will not know if they are in the essential oil arm or the pure fragrance oil arm.
Primary Purpose: Treatment
Official Title: Olfactory Training for Olfactory Dysfunction in Chronic Rhinosinusitis

Further study details as provided by Thomas S. Edwards, MD, Emory University:

Primary Outcome Measures:
  • 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".


Estimated Enrollment: 150
Anticipated Study Start Date: October 1, 2017
Estimated Study Completion Date: September 30, 2018
Estimated Primary Completion Date: September 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Olfactory Training with Essential Oils
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.
Other: Olfactory Training with Pure Fragrance Oils
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03055572

Contacts
Contact: Melissa R Rotella, APRN 404-778-3381 melissa.rotella@emoryhealthcare.org
Contact: Thomas Edwards, MD 404-778-3381 thomas.edwards@emory.edu

Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Thomas Edwards, MD Emory University
  More Information

Responsible Party: Thomas S. Edwards, MD, Medical House Staff, Department of Otolaryngology - Head and Neck Surgery, Emory University
ClinicalTrials.gov Identifier: NCT03055572     History of Changes
Other Study ID Numbers: IRB00094289
Study First Received: February 14, 2017
Last Updated: February 14, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thomas S. Edwards, MD, Emory University:
Rhinitis
Chronic Rhinosinusitis
Olfactory Training

ClinicalTrials.gov processed this record on August 18, 2017