SNIFFED: Steroid Nasal Irrigation for Flavor Evaluation and Detection Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Olfactory dysfunction affects up to fifteen percent of the general population and can cause significant psychosocial distress including decreased appetite, reduced self-hygiene, and mood disturbances.
This study aims to study the efficacy of smell training for patients with olfactory dysfunction following a viral upper respiratory tract infection. Eligible participants will complete a 30-day course of budesonide nasal saline irrigation. Participants who do not show improvement in their olfaction based on composite smell and taste tests will be eligible to receive a baseline resting-state fMRI (rs-fMRI) and complete a 12-week smell training intervention program. Smell training involves participants smelling 4 odors (phenyl ethyl alcohol, eucalyptus, lemon, and eugenol) twice a day for 12 weeks. Following completion of smell training, participants will undergo repeat smell and taste tests as well as rs-fMRI to ascertain the efficacy of smell training.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Smell Training Participants will first undergo a 30-day trial of budesonide nasal saline irrigation. If there is no subsequent improvement in olfaction, participants will undergo a 12-week smell training intervention. |
Combination Product: Smell training
Eligible participants will be provided with a "NeilMed" Sinus Rinse Regular Bottle Kit and a one-month supply of USP Grade Sodium Chloride & Sodium Bicarbonate Mixture commercially prepared packets. Participants will need to purchase distilled water or boil tap water for five minutes for use with the saline irrigation. The contents of two capsules (0.5mg budesonide each) will be dissolved into "NeilMed" Sinus Rinse Regular Bottle along with the saline rinse. Both nasal cavities will be irrigated once daily for 30 days.
Participants who do not have objective improvement in their olfaction after the trial of budesonide irrigation will have a baseline resting-state fMRI (rs-fMRI) and undergo 12 weeks of smell training. Smell training involves the participants smelling 4 vials of essential odors twice a day for 12 weeks. Following smell training, participants will have their smell ability re-evaluated and a second rs-fMRI performed.
|
Outcome Measures
Primary Outcome Measures
- Pre- and post-intervention difference in smell testing before and after smell training intervention [12 weeks]
Objective pre- and post-intervention differences of participant performance on the UPSIT and Sniffin Sticks tests, validated psychosocial instruments, before and after smell intervention training will be obtained.
- Pre- and post-intervention difference in neuroplasticity before and after smell training [12 weeks]
Baseline and post-intervention connectivity in and between regions of interest in the olfactory and olfactory related networks using resting state fMRI will be obtained.
Secondary Outcome Measures
- Pre- and post-intervention difference in smell testing before and after budesonide treatment [30 days]
Objective pre- and post-intervention differences of participant performance on the UPSIT and Sniffin Sticks tests before and after budesonide saline nasal irrigation
- Subjective response of budesonide nasal saline irrigation [30 days]
Participants will be asked to fill out an intervention-specific form (Clinical Global Impression) rating how they feel they've responded to budesonide treatment from "Excellent" response to "Poor" response to budesonide nasal saline irrigation. This provides a subjective measurement to go along with the study's objective measures of smell and taste test performance.
- Subjective response to smell training intervention [12 weeks]
Participants will be asked to fill out an intervention-specific form (Clinical Global Impression) rating how they feel they've responded to smell training from "Excellent" response to "Poor" response to smell training intervention. This provides a subjective measurement to go along with the study's objective measures of smell and taste test performance.
- Characterization of olfactory network in healthy controls [1 week]
Baseline functional connectivity within and between the olfactory and associated networks of healthy controls will be compared to that of study participants as measured by rs-fMRI.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age between 18 and 70
-
Anosmia or hyposmia (UPSIT <34 (male), UPSIT <34 (female); Sniffin' Sticks threshold below 5.5)
Exclusion Criteria:
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Inability to understand English
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Current smoker or history of smoking within the past 6 months
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Current nasal polyps
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Exposure to head and or/neck radiation
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Exposure to chemotherapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- 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.
- 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.
- Cowart BJ. Relationships between taste and smell across the adult life span. Ann N Y Acad Sci. 1989;561:39-55.
- 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.
- 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.
- Hummel T, Rissom K, Reden J, Hähner A, Weidenbecher M, Hüttenbrink KB. Effects of olfactory training in patients with olfactory loss. Laryngoscope. 2009 Mar;119(3):496-9. doi: 10.1002/lary.20101.
- 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.
- 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. Epub 2007 Jan 13.
- 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.
- 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. Review.
- 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.
- 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.
- 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.
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