Acupuncture Therapy for COVID-Related Olfactory Loss

Study Overview
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Brief Summary
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This study is looking at the role of acupuncture as a treatment for olfactory dysfunction in patients who tested positive for COVID-19.

Official Title
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Acupuncture Therapy for COVID-Related Olfactory Loss

Conditions
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Olfactory Dysfunction, COVID-19

Intervention / Treatment
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* Device: Acupuncture Therapy
* Drug: Budesonide
* Other: Olfactory Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older. Patients with post-viral olfactory dysfunction > 4 weeks. History of positive COVID-19 PCR. Exclusion Criteria: Less than 18 years of age. Active sinus infection. New diagnosis of untreated CRS. Prior diagnosis of dementia or Parkinson's disease. Prior head trauma or neurosurgical procedure resulting in olfactory loss. Patients who do not speak or read English. Patients unable to understand and sign the study consent.

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 |
| --- | --- |
| Experimental: Acupuncture Therapy Group<br>Subjects will undergo ten sessions of acupuncture therapy with a licensed acupuncturist in addition to the standard of care. | Device: Acupuncture Therapy<br>* Consists of two treatments per week for five weeks<br>Drug: Budesonide<br>* Twice daily nasal rinses with steroid medication (budesonide)<br>Other: Olfactory Training<br>* involves smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse)<br>|
| Active Comparator: Standard of Care<br>Subjects will be treated with two times daily budesonide rinses and olfactory (sense of smell) training. This is considered the current standard of care in the treatment of olfactory dysfunction. | Drug: Budesonide<br>* Twice daily nasal rinses with steroid medication (budesonide)<br>Other: Olfactory Training<br>* involves smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in UPSIT scores |  | Baseline, post-treatment approximately 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient-reported subjective olfactory loss | Patient-reported subjective olfactory loss measured by a 10-point visual analog scale with 0 representing no sense of smell and 10 representing normal smell. | Baseline, post-treatment approximately 12 weeks | 
| Change in Sino-Nasal Outcome Test (SNOT-22) | Patient-reported subjective olfactory loss measured by SNOT-22 questionnaire, rating symptoms experiences from 0 = no problem, 5 = problem as bad as it can be | Baseline, post-treatment approximately 12 weeks |