Anosmia Rehabilitation in Patients Post Coronavirus Disease (COVID 19)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: Control Group 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. |
Other: smell household Items
Participants will receive a paper hand-out about post-viral anosmia with instructions to smell common household items
Other: Nasal Irrigation
Participants from all three groups will use nasal rinse (NeilMed Sinus Rinse) two times a day.
Other Names:
|
| Experimental: Olfactory Retraining Group 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. |
Other: Olfactory retraining
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.
Other Names:
Other: Nasal Irrigation
Participants from all three groups will use nasal rinse (NeilMed Sinus Rinse) two times a day.
Other Names:
|
| Experimental: Olfactory Retraining_Budesonide Group 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. |
Other: Olfactory retraining
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.
Other Names:
Drug: corticosteroid nasal irrigation
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).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline Snap and Sniff Threshold Test at 3 months [3 months]
Score from the Snap and Sniff Olfactory Test results
- Change from baseline Smell Identification Test (SIT) at 3 months [3 months]
Score from the Smell Identification test results.
- Change from Baseline Snap and Sniff Threshold Test at 6 months [6 months]
Score from the Snap and Sniff Olfactory Test results
- Change from baseline Smell Identification Test (SIT) at 6 months [6 months]
Score from the Smell Identification test results.
Secondary Outcome Measures
- Change from baseline QOD-NS at 3 months [3 months]
Scores from the short version of the Questionnaire of Olfactory Disorders Negative Statements (QOD-NS)
- Change from baseline SF-36 health survey at 3 months [3 months]
Short Form 36 Health Survey scores
- Change from baseline QOD-NS at 6 months [6 months]
Scores from the short version of the Questionnaire of Olfactory Disorders Negative Statements (QOD-NS)
- Change from baseline SF-36 health survey at 6 months [6 months]
Short Form 36 Health Survey scores
- Adherence to the Study Protocol [6 months]
Adherence comparison between participants post-CoVID 19 and patients post other viral infections.
- Recovery [6 months]
Compare the rate of recovery between post-COVID 19 patients and patients post other viral infections.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adults 18 years of age or older
-
Hyposmia/anosmia of onset immediately after an upper respiratory viral illness confirmed on Snap n' Sniff threshold testing,
-
Capable, in the opinion of the primary investigator, of providing informed consent to participate in the study. Participants are required to sign an informed consent form indicating they understand the purpose and nature of the study, and that they are willing to participate.
Exclusion Criteria:
-
active cigarette smoker
-
chronic rhinosinusitis
-
head trauma with loss of consciousness
-
inability to read/understand English
-
previous hyposmia/anosmia complaint
-
pregnancy
-
previous sinus
-
skull base or brain surgery
-
current participation in another clinical trial at the time of initial visit
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Joseph's Health Care | London | Ontario | Canada | N5A 4V2 |
Sponsors and Collaborators
- Lawson Health Research Institute
Investigators
- Principal Investigator: Leigh Sowerby, MD, FRCSC, Western University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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. Review.
- 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.
- 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.
- 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.
- 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.
- Anosmia_CoVID 19