Anosmia Rehabilitation in Patients Post Coronavirus Disease (COVID 19)

Study Overview
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Brief Summary
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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.

Official Title
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Olfactory Retraining Therapy and Budesonide Nasal Rinse for Anosmia Treatment in Patients Post-CoVID 19. A Randomized Controlled Trial

Conditions
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Olfactory Disorder

Intervention / Treatment
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* Other: Olfactory retraining
* Drug: corticosteroid nasal irrigation
* Other: smell household Items
* Other: Nasal Irrigation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control Group<br>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<br>* Participants will receive a paper hand-out about post-viral anosmia with instructions to smell common household items<br>Other: Nasal Irrigation<br>* Participants from all three groups will use nasal rinse (NeilMed Sinus Rinse) two times a day.<br>* Other names: Nasal Rinse;|
| Experimental: Olfactory Retraining Group<br>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<br>* 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.<br>* Other names: smell training;Other: Nasal Irrigation<br>* Participants from all three groups will use nasal rinse (NeilMed Sinus Rinse) two times a day.<br>* Other names: Nasal Rinse;|
| Experimental: Olfactory Retraining_Budesonide Group<br>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<br>* 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.<br>* Other names: smell training;Drug: corticosteroid nasal irrigation<br>* 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).<br>* Other names: Budesonide nasal irrigation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anosmia, hyposmia, CoVID19, post-viral anosmia, snap and sniff olfactory test, budesonide