Olfactory DysfunctionNCT04952389
Acupuncture Therapy for COVID-Related Olfactory Loss
A study testing Acupuncture Therapy, Budesonide and Olfactory Training in people with Olfactory Dysfunction and COVID-19, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is looking at the role of acupuncture as a treatment for olfactory dysfunction in patients who tested positive for COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Olfactory Dysfunction, COVID-19
- What is being tested?
- Acupuncture Therapy, Budesonide and Olfactory Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2021to 9 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older.
- Patients with post-viral olfactory dysfunction > 4 weeks.
- History of positive COVID-19 PCR.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
This study is looking at the role of acupuncture as a treatment for olfactory dysfunction in patients who tested positive for COVID-19.
- Conditions
- Olfactory Dysfunction, COVID-19
- Being tested
- Acupuncture Therapy, Budesonide, Olfactory Training
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture TherapyDevice
Consists of two treatments per week for five weeks
BudesonideDrug
Twice daily nasal rinses with steroid medication (budesonide)
Olfactory TrainingOther
involves smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse)
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Therapy Group | Experimental | Subjects will undergo ten sessions of acupuncture therapy with a licensed acupuncturist in addition to the standard of care. Receives: Device: Acupuncture Therapy; Drug: Budesonide; Other: Olfactory Training |
| 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. Receives: Drug: Budesonide; Other: Olfactory Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, post-treatment approximately 12 weeks
Secondary outcomes (2)
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.
Measured: 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, with a total score ranging of 0-110, lower scores indicate no problem and higher scores indicate more problem.
Measured: Baseline, post-treatment approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start7 Dec 2021
- Primary completion21 Apr 2023
- Study completion9 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Olfactory DysfunctionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janalee K. Stokken, Mayo Clinic
- Investigators
- Janalee Stokken, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952389
- Sponsor's protocol ID
- 21-003531
- Status last verified
- Feb 2024
- First submitted
- 2 Jul 2021
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Therapy for COVID-Related Olfactory Loss
- ClinicalTrials.gov ID
- NCT04952389
- Acronym / sponsor ID
- 21-003531
- Conditions
- Olfactory Dysfunction, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 9 Jun 2023 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is looking at the role of acupuncture as a treatment for olfactory dysfunction in patients who tested positive for COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Therapy Group | Experimental | Device: Acupuncture Therapy, Drug: Budesonide, Other: Olfactory TrainingSubjects will undergo ten sessions of acupuncture therapy with a licensed acupuncturist in addition to the standard of care. |
| Standard of Care | Active comparator | Drug: Budesonide, Other: Olfactory TrainingSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older.
- Patients with post-viral olfactory dysfunction > 4 weeks.
- History of positive COVID-19 PCR.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture TherapyConsists of two treatments per week for five weeks | Device | Acupuncture Therapy Group |
| BudesonideTwice daily nasal rinses with steroid medication (budesonide) | Drug | Acupuncture Therapy Group, Standard of Care |
| Olfactory Traininginvolves smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse) | Other | Acupuncture Therapy Group, Standard of Care |
Primary outcome
Change in University of Pennsylvania Smell Identification Test (UPSIT) Scores
Time frame: 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.
2 secondary outcomes
Change in Patient-reported Subjective Olfactory Loss
Time frame: Baseline, post-treatment approximately 12 weeks
Change in Sino-Nasal Outcome Test (SNOT-22)
Time frame: Baseline, post-treatment approximately 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Olfactory Dysfunction
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Position-Directed Budesonide Nasal Drops for CRS-associated Olfactory Dysfunction
Chronic Rhinosinusitis (CRS), Olfactory Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janalee Stokken, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture Therapy, Budesonide and Olfactory Training in people with Olfactory Dysfunction and COVID-19, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in University of Pennsylvania Smell Identification Test (UPSIT) Scores (time frame: Baseline, post-treatment approximately 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.