Steroid Nasal Irrigation for Flavor Evaluation and Detection Study

NCT02985515 | Completed Results DMC

• 1 other identifier: 201608163
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to examine the efficacy of a 12-week smell training intervention for participants with olfactory dysfunction following an infection of the upper respiratory tract.

Conditions

Olfactory Disorder

Keywords

Anosmia; Hyposmia; Intranasal Steroid Irrigation; Olfactory Neuroplasticity; Olfactory training

Outcome Measures

Primary Outcomes (1)

• Pre- and Post-intervention Difference in Functional Connectivity Before and After Smell Training.

  Baseline and post-intervention connectivity within and between regions of interest in the olfactory and olfactory related networks using resting state fMRI will be obtained. Resting-state connectivity was analyzed using the CONN toolbox version 18b (https://web.conn-toolbox.org/) and SPM12, version 7487 (Wellcome Trust Centre for Neuroimaging). Functional connectivity values (Fisher z-transformed Pearson correlation coefficients) were compared using a paired, 2-tailed t test and corrected for multiple comparisons. p\<0.05 was considered to be significant.

  12 weeks

Secondary Outcomes (5)

• Pre- and Post-intervention Difference in Smell Testing Before and After Budesonide Treatment

  30 days

• Subjective Response to Smell Training Intervention

  12 weeks

• Comparison of Olfactory Network in Healthy Controls to Study Participants

  1 week

• Pre- and Post-intervention Difference in Smell Testing Before and After Smell Training

  12 weeks

• Pre and Post Difference in QOD-NS After Smell Training

  12 weeks

Study Arms (3)

Budesonide Nasal Irrigation

NO INTERVENTION

30-day run-in course of budesonide nasal irrigation. 1-month supply of budesonide capsules, an 8-oz sinus rinse bottle, and a 1-month supply of commercially prepared isotonic salt packets. Participants were instructed to dissolve 2 budesonide capsules (0.5mg per capsule) into the sinus rinse bottle along with the saline mixture and then irrigate both nasal cavities once daily.

Budesonide Nasal Irrigation + Smell Training

EXPERIMENTAL

Budesonide nasal irrigation + smell training for 12 weeks

Behavioral: Smell training

Controls

NO INTERVENTION

Baseline olfaction testing and rs-fMRI

Interventions

Smell training BEHAVIORAL

Participants will be provided with 4 vials of essential odors. Participants will sniff each scent for 20-30 seconds, twice daily, for 12 weeks. The participant will take 30 seconds of rest between each scent. All participants will undergo this smell training regimen for 12 weeks.

Also known as: Olfactory Training

Budesonide Nasal Irrigation + Smell Training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70
• Anosmia or hyposmia (UPSIT \<34 (male), UPSIT \<34 (female); Sniffin' Sticks threshold below 5.5)

You may not qualify if:

• Inability to understand English
• Current smoker or history of smoking within the past 6 months
• Current nasal polyps
• Exposure to head and or/neck radiation
• Exposure to chemotherapy

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (14)

• Deems DA, Doty RL, Settle RG, Moore-Gillon V, Shaman P, Mester AF, Kimmelman CP, Brightman VJ, Snow JB Jr. Smell and taste disorders, a study of 750 patients from the University of Pennsylvania Smell and Taste Center. Arch Otolaryngol Head Neck Surg. 1991 May;117(5):519-28. doi: 10.1001/archotol.1991.01870170065015.

  PMID: 2021470 BACKGROUND

• Doty RL, Frye RE, Agrawal U. Internal consistency reliability of the fractionated and whole University of Pennsylvania Smell Identification Test. Percept Psychophys. 1989 May;45(5):381-4. doi: 10.3758/bf03210709.

  PMID: 2726398 BACKGROUND

• Hummel T, Sekinger B, Wolf SR, Pauli E, Kobal G. 'Sniffin' sticks': olfactory performance assessed by the combined testing of odor identification, odor discrimination and olfactory threshold. Chem Senses. 1997 Feb;22(1):39-52. doi: 10.1093/chemse/22.1.39.

  PMID: 9056084 BACKGROUND

• Kobal G, Hummel T, Sekinger B, Barz S, Roscher S, Wolf S. "Sniffin' sticks": screening of olfactory performance. Rhinology. 1996 Dec;34(4):222-6.

  PMID: 9050101 BACKGROUND

• Coldwell SE, Mennella JA, Duffy VB, Pelchat ML, Griffith JW, Smutzer G, Cowart BJ, Breslin PA, Bartoshuk LM, Hastings L, Victorson D, Hoffman HJ. Gustation assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S20-4. doi: 10.1212/WNL.0b013e3182872e38.

  PMID: 23479539 BACKGROUND

• Bartoshuk LM, Duffy VB, Hayes JE, Moskowitz HR, Snyder DJ. Psychophysics of sweet and fat perception in obesity: problems, solutions and new perspectives. Philos Trans R Soc Lond B Biol Sci. 2006 Jul 29;361(1471):1137-48. doi: 10.1098/rstb.2006.1853.

  PMID: 16815797 BACKGROUND

• Pepino MY, Finkbeiner S, Beauchamp GK, Mennella JA. Obese women have lower monosodium glutamate taste sensitivity and prefer higher concentrations than do normal-weight women. Obesity (Silver Spring). 2010 May;18(5):959-65. doi: 10.1038/oby.2009.493. Epub 2010 Jan 14.

  PMID: 20075854 BACKGROUND

• Cicerale S, Breslin PA, Beauchamp GK, Keast RS. Sensory characterization of the irritant properties of oleocanthal, a natural anti-inflammatory agent in extra virgin olive oils. Chem Senses. 2009 May;34(4):333-9. doi: 10.1093/chemse/bjp006. Epub 2009 Mar 8.

  PMID: 19273462 BACKGROUND

• Keast RS, Roper J. A complex relationship among chemical concentration, detection threshold, and suprathreshold intensity of bitter compounds. Chem Senses. 2007 Mar;32(3):245-53. doi: 10.1093/chemse/bjl052. Epub 2007 Jan 13.

  PMID: 17220518 BACKGROUND

• Cowart BJ. Relationships between taste and smell across the adult life span. Ann N Y Acad Sci. 1989;561:39-55. doi: 10.1111/j.1749-6632.1989.tb20968.x. No abstract available.

  PMID: 2735688 BACKGROUND

• Hummel T, Rissom K, Reden J, Hahner A, Weidenbecher M, Huttenbrink KB. Effects of olfactory training in patients with olfactory loss. Laryngoscope. 2009 Mar;119(3):496-9. doi: 10.1002/lary.20101.

  PMID: 19235739 BACKGROUND

• Stamps JJ, Bartoshuk LM, Heilman KM. A brief olfactory test for Alzheimer's disease. J Neurol Sci. 2013 Oct 15;333(1-2):19-24. doi: 10.1016/j.jns.2013.06.033. Epub 2013 Aug 5.

  PMID: 23927938 BACKGROUND

• Tepper BJ, Christensen CM, Cao J. Development of brief methods to classify individuals by PROP taster status. Physiol Behav. 2001 Jul;73(4):571-7. doi: 10.1016/s0031-9384(01)00500-5.

  PMID: 11495661 BACKGROUND

• Pekala K, Chandra RK, Turner JH. Efficacy of olfactory training in patients with olfactory loss: a systematic review and meta-analysis. Int Forum Allergy Rhinol. 2016 Mar;6(3):299-307. doi: 10.1002/alr.21669. Epub 2015 Dec 1.

  PMID: 26624966 BACKGROUND

MeSH Terms

Conditions

Anosmia

Interventions

Olfactory Training

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Pawina JIramongkolchai, MD
• Organization: Washington University in St. Louis

pawina@wustl.edu

314-393-2455

Study Officials

• Jay F Piccirillo, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective cohort, pre- and post-intervention study

Study Record Dates

• First Submitted: December 3, 2016
• First Posted: December 7, 2016
• Study Start: September 28, 2016
• Primary Completion: November 20, 2019
• Study Completion: November 20, 2019
• Last Updated: November 4, 2022
• Results First Posted: November 4, 2022

Record last verified: 2022-11

Locations

US (1)