Acupuncture Therapy for COVID-Related Olfactory Loss

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04952389
Collaborator
(none)
100
1
2
19.8
5.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Acupuncture Therapy for COVID-Related Olfactory Loss
Actual Study Start Date :
Dec 7, 2021
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Acupuncture Therapy Group

Subjects will undergo ten sessions of acupuncture therapy with a licensed acupuncturist in addition to the standard of care.

Device: Acupuncture Therapy
Consists of two treatments per week for five weeks

Drug: Budesonide
Twice daily nasal rinses with steroid medication (budesonide)

Other: Olfactory 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)

Active Comparator: Standard of Care

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
Twice daily nasal rinses with steroid medication (budesonide)

Other: Olfactory 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)

Outcome Measures

Primary Outcome Measures

  1. Change in UPSIT scores [Baseline, post-treatment approximately 12 weeks]

Secondary Outcome Measures

  1. 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 0 representing no sense of smell and 10 representing normal smell.

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Janalee Stokken, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Janalee K. Stokken, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04952389
Other Study ID Numbers:
  • 21-003531
First Posted:
Jul 7, 2021
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2022