Olfactory Dysfunction, COVID-19
Conditions
Brief summary
This study is looking at the role of acupuncture as a treatment for olfactory dysfunction in patients who tested positive for COVID-19.
Interventions
DEVICEAcupuncture Therapy
Consists of two treatments per week for five weeks
DRUGBudesonide
Twice daily nasal rinses with steroid medication (budesonide)
OTHEROlfactory Training
involves smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse)
Sponsors
Mayo Clinic
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in University of Pennsylvania Smell Identification Test (UPSIT) Scores | Baseline, post-treatment approximately 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient-reported Subjective Olfactory Loss | Baseline, post-treatment approximately 12 weeks | 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. |
| Change in Sino-Nasal Outcome Test (SNOT-22) | Baseline, post-treatment approximately 12 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 15 |
| 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) | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 8 | 4 |
Baseline characteristics
| Characteristic | Acupuncture Therapy Group | Standard of Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 13 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 14 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 12 Participants | 15 Participants | 27 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 1 / 15 | 1 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
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.
Time frame: Baseline, post-treatment approximately 12 weeks
Population: Data not collected nor analyzed for eight subjects in the Acupuncture arm and four subjects in the Standard of Care arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture Therapy Group | Change in University of Pennsylvania Smell Identification Test (UPSIT) Scores | 2.571 score on a scale | Standard Deviation 5.997 |
| Standard of Care | Change in University of Pennsylvania Smell Identification Test (UPSIT) Scores | 3.182 score on a scale | Standard Deviation 5.306 |
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.
Time frame: Baseline, post-treatment approximately 12 weeks
Population: Data not collected nor analyzed for eight subjects in the Acupuncture arm and four subjects in the Standard of Care arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture Therapy Group | Change in Patient-reported Subjective Olfactory Loss | 1.857 score on a scale | Standard Deviation 2.167 |
| Standard of Care | Change in Patient-reported Subjective Olfactory Loss | 1.727 score on a scale | Standard Deviation 2.125 |
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.
Time frame: Baseline, post-treatment approximately 12 weeks
Population: Data not collected nor analyzed for eight subjects in the Acupuncture arm and four subjects in the Standard of Care arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture Therapy Group | Change in Sino-Nasal Outcome Test (SNOT-22) | 7.143 score on a scale | Standard Deviation 9.746 |
| Standard of Care | Change in Sino-Nasal Outcome Test (SNOT-22) | 3.455 score on a scale | Standard Deviation 15.035 |