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Study withdrawn before any enrollment (site's research goals adjustments).
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The study will be a randomized controlled trial, involving patients with hyposmia/anosmia of onset immediately after an upper respiratory viral illness, assigned to three distinct study arms. Nasal irrigations will be prescribed to all three groups (BID). In addition, one arm will receive a paper hand-out about post-viral anosmia with instructions to smell common household items (current care) and act as a control group. The second group will receive an essential oil retraining kit, whereas the third group will receive the same olfactory training kit and a prescription to use budesonide with the nasal irrigations. Olfactory scores will be tested at the enrollment, 3 months and at 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Sham Comparator | The participants, randomly assigned to this arm, will receive a paper hand-out about post-viral anosmia with instructions to smell common household items (current care). Besides, it will be prescribed nasal irrigation twice a day. |
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| Olfactory Retraining Group | Experimental | The participants, randomly assigned to this arm, will receive instructions on olfactory retraining and will also be given an essential oil retraining kit, which they will use twice a day. Besides, it will be prescribed nasal irrigation twice a day. |
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| Olfactory Retraining_Budesonide Group | Experimental | The participants, randomly assigned to this arm, will receive instructions on olfactory retraining, the olfactory training kit and it will be prescribed nasal irrigation with Budesonise, twice a day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olfactory retraining | Other | Olfactory retraining Olfactory training is performed by exposing patients twice daily to essential oils with four specific odors, present in glass jars with soaked cotton pads: phenyl ethyl alcohol, rose; eucalyptol, eucalyptus; citronellal, lemon; eugenol, cloves. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Snap and Sniff Threshold Test at 3 months | Score from the Snap and Sniff Olfactory Test results | 3 months |
| Change from baseline Smell Identification Test (SIT) at 3 months | Score from the Smell Identification test results. | 3 months |
| Change from Baseline Snap and Sniff Threshold Test at 6 months | Score from the Snap and Sniff Olfactory Test results | 6 months |
| Change from baseline Smell Identification Test (SIT) at 6 months | Score from the Smell Identification test results. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline QOD-NS at 3 months | Scores from the short version of the Questionnaire of Olfactory Disorders Negative Statements (QOD-NS) | 3 months |
| Change from baseline SF-36 health survey at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leigh Sowerby, MD, FRCSC | Western University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Health Care | London | Ontario | N5A 4V2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18677645 | Background | Vennemann MM, Hummel T, Berger K. The association between smoking and smell and taste impairment in the general population. J Neurol. 2008 Aug;255(8):1121-6. doi: 10.1007/s00415-008-0807-9. Epub 2008 Jul 28. | |
| 24429163 | Background | Croy I, Nordin S, Hummel T. Olfactory disorders and quality of life--an updated review. Chem Senses. 2014 Mar;39(3):185-94. doi: 10.1093/chemse/bjt072. Epub 2014 Jan 15. |
| Label | URL |
|---|---|
| Snap and Sniff threshold test informative website | View source |
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| ID | Term |
|---|---|
| D000086582 | Anosmia |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D000857 | Olfaction Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000094562 | Olfactory Training |
| D055556 | Nasal Lavage |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D007507 | Therapeutic Irrigation |
| D008919 | Investigative Techniques |
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|
| corticosteroid nasal irrigation | Drug | Nasal irrigation with corticosteroid (budesonide) consists of 240-mL nasal irrigation with Pulmicort Respules (0.5mg) across both nose sides via NeilMed Sinus Rinse bottle (Santa Rosa, California, USA). |
|
|
| smell household Items | Other | Participants will receive a paper hand-out about post-viral anosmia with instructions to smell common household items |
|
| Nasal Irrigation | Other | Participants from all three groups will use nasal rinse (NeilMed Sinus Rinse) two times a day. |
|
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Short Form 36 Health Survey scores
| 3 months |
| Change from baseline QOD-NS at 6 months | Scores from the short version of the Questionnaire of Olfactory Disorders Negative Statements (QOD-NS) | 6 months |
| Change from baseline SF-36 health survey at 6 months | Short Form 36 Health Survey scores | 6 months |
| Adherence to the Study Protocol | Adherence comparison between participants post-CoVID 19 and patients post other viral infections. | 6 months |
| Recovery | Compare the rate of recovery between post-COVID 19 patients and patients post other viral infections. | 6 months |
| 24114690 | Background | Konstantinidis I, Tsakiropoulou E, Bekiaridou P, Kazantzidou C, Constantinidis J. Use of olfactory training in post-traumatic and postinfectious olfactory dysfunction. Laryngoscope. 2013 Dec;123(12):E85-90. doi: 10.1002/lary.24390. Epub 2013 Oct 4. |
| 29901865 | Background | Nguyen TP, Patel ZM. Budesonide irrigation with olfactory training improves outcomes compared with olfactory training alone in patients with olfactory loss. Int Forum Allergy Rhinol. 2018 Sep;8(9):977-981. doi: 10.1002/alr.22140. Epub 2018 Jun 14. |
| 31430061 | Background | Mattos JL, Edwards C, Schlosser RJ, Hyer M, Mace JC, Smith TL, Soler ZM. A brief version of the questionnaire of olfactory disorders in patients with chronic rhinosinusitis. Int Forum Allergy Rhinol. 2019 Oct;9(10):1144-1150. doi: 10.1002/alr.22392. Epub 2019 Aug 20. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |