Acupuncture Therapy for COVID-Related Olfactory Loss

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

Study Overview

• Status: Completed
• Conditions: COVID-19; Olfactory Dysfunction
• Intervention / Treatment: Device: Acupuncture Therapy; Drug: Budesonide; Other: Olfactory Training

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

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 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)	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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Janalee Stokken, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2021
• Primary Completion (Actual): April 21, 2023
• Study Completion (Actual): June 9, 2023

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 2, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: 21-003531

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes