Olfactory Disorder
Conditions
Keywords
anosmia, hyposmia, CoVID19, post-viral anosmia, snap and sniff olfactory test, budesonide
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.
Interventions
OTHEROlfactory 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.
DRUGcorticosteroid 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).
OTHERsmell household Items
Participants will receive a paper hand-out about post-viral anosmia with instructions to smell common household items
OTHERNasal Irrigation
Participants from all three groups will use nasal rinse (NeilMed Sinus Rinse) two times a day.
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Adherence to the Study Protocol | 6 months | Adherence comparison between participants post-CoVID 19 and patients post other viral infections. |
| 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) |
| Recovery | 6 months | Compare the rate of recovery between post-COVID 19 patients and patients post other viral infections. |
| 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 |
Countries
Canada
Outcome results
None listed