Olfactory Training in Chronic Rhinosinusitis

NCT03055572 | Withdrawn

• 1 other identifier: IRB00094289
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Olfactory Dysfunction

Keywords

Rhinitis; Chronic Rhinosinusitis; Olfactory Training

Outcome Measures

Primary Outcomes (2)

• 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.

  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".

  Baseline, Week 4, Week 8, and Week 12

Study Arms (3)

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.

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.

Other: Olfactory Training with Pure Fragrance Oils

Control Group

NO INTERVENTION

The control group will continue the medical therapy prescribed by their provider.

Interventions

Olfactory Training with Essential Oils OTHER

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 Essential Oils

Olfactory Training with Pure Fragrance Oils OTHER

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.

Olfactory Training with Pure Fragrance Oils

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

MeSH Terms

Conditions

Rhinitis

Interventions

Olfactory Training; Oils, Volatile

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Oils; Lipids

Study Officials

• Thomas Edwards, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical House Staff, Department of Otolaryngology - Head and Neck Surgery

Model Details: Participants are randomized into one of three study arms: essential oil arm, pure fragrance oil arm, and control arm.

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 16, 2017
• Study Start: March 1, 2019
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: May 30, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share