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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture Therapy Group | Experimental | Subjects will undergo ten sessions of acupuncture therapy with a licensed acupuncturist in addition to the standard of care. |
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| Standard of Care | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture Therapy | Device | Consists of two treatments per week for five weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in University of Pennsylvania Smell Identification Test (UPSIT) Scores | The 40-item UPSIT is a measurement of the ability to detect odors where microencapsulated odorants on a strip are released by scratching. Each item is scored from 0 (did not correctly detect the odor) to 1 (correctly detected the odor). Total scores range from 0-40 with higher scores indicating better smell and lower scores indicating worse smell. | Baseline, post-treatment approximately 12 weeks |
| 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 10 representing no sense of smell and 1 representing normal smell. | Baseline, post-treatment approximately 12 weeks |
| Change in Sino-Nasal Outcome Test (SNOT-22) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janalee Stokken, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acupuncture Therapy Group | Subjects underwent ten sessions of acupuncture therapy with a licensed acupuncturist in addition to the standard of care. Acupuncture Therapy: Consisted of two treatments per week for five weeks Budesonide: Twice daily nasal rinses with steroid medication (budesonide) Olfactory Training: involved smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse) |
| FG001 | Standard of Care | Subjects were 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. Budesonide: Twice daily nasal rinses with steroid medication (budesonide) Olfactory Training: involved smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Acupuncture Therapy Group | Subjects underwent ten sessions of acupuncture therapy with a licensed acupuncturist in addition to the standard of care. Acupuncture Therapy: Consisted of two treatments per week for five weeks Budesonide: Twice daily nasal rinses with steroid medication (budesonide) Olfactory Training: involved smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in University of Pennsylvania Smell Identification Test (UPSIT) Scores | The 40-item UPSIT is a measurement of the ability to detect odors where microencapsulated odorants on a strip are released by scratching. Each item is scored from 0 (did not correctly detect the odor) to 1 (correctly detected the odor). Total scores range from 0-40 with higher scores indicating better smell and lower scores indicating worse smell. | Data not collected nor analyzed for eight subjects in the Acupuncture arm and four subjects in the Standard of Care arm | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-treatment approximately 12 weeks |
|
Adverse Events were collected from baseline until end of study, approximately 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acupuncture Therapy Group | Subjects underwent ten sessions of acupuncture therapy with a licensed acupuncturist in addition to the standard of care. Acupuncture Therapy: Consisted of two treatments per week for five weeks Budesonide: Twice daily nasal rinses with steroid medication (budesonide) Olfactory Training: involved smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janalee K. Stokken, M.D. | Mayo Clinic | 507-284-1482 | Stokken.Janalee@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 23, 2021 | Feb 14, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D019819 | Budesonide |
| D000094562 | Olfactory Training |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
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| Budesonide | Drug | Twice daily nasal rinses with steroid medication (budesonide) |
|
| Olfactory Training | Other | involves smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse) |
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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, with a total score ranging of 0-110, lower scores indicate no problem and higher scores indicate more problem. |
| Baseline, post-treatment approximately 12 weeks |
| BG001 | Standard of Care | Subjects were 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. Budesonide: Twice daily nasal rinses with steroid medication (budesonide) Olfactory Training: involved smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse) |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Standard of Care | Subjects were 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. Budesonide: Twice daily nasal rinses with steroid medication (budesonide) Olfactory Training: involved smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse) |
|
|
| Secondary | Change in Patient-reported Subjective Olfactory Loss | Patient-reported subjective olfactory loss measured by a 10-point visual analog scale with 10 representing no sense of smell and 1 representing normal smell. | Data not collected nor analyzed for eight subjects in the Acupuncture arm and four subjects in the Standard of Care arm | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-treatment approximately 12 weeks |
|
|
|
| Secondary | 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, with a total score ranging of 0-110, lower scores indicate no problem and higher scores indicate more problem. | Data not collected nor analyzed for eight subjects in the Acupuncture arm and four subjects in the Standard of Care arm | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-treatment approximately 12 weeks |
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|
| 0 |
| 15 |
| 0 |
| 15 |
| 1 |
| 15 |
| EG001 | Standard of Care | Subjects were 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. Budesonide: Twice daily nasal rinses with steroid medication (budesonide) Olfactory Training: involved smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse) | 0 | 15 | 0 | 15 | 1 | 15 |
| Brain fog | Nervous system disorders | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011278 |
| Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |