Acupuncture Therapy for COVID-Related Olfactory Loss

NCT04952389 | Completed Results FDA Device

• 1 other identifier: 21-003531
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Olfactory Dysfunction; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Patient-reported Subjective Olfactory Loss

  Baseline, post-treatment approximately 12 weeks

• Change in Sino-Nasal Outcome Test (SNOT-22)

  Baseline, post-treatment approximately 12 weeks

Study Arms (2)

Acupuncture Therapy Group

EXPERIMENTAL

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

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.

Drug: Budesonide; Other: Olfactory Training

Interventions

Acupuncture Therapy DEVICE

Consists of two treatments per week for five weeks

Acupuncture Therapy Group

Budesonide DRUG

Twice daily nasal rinses with steroid medication (budesonide)

Acupuncture Therapy Group; Standard of Care

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)

Acupuncture Therapy Group; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older.
• Patients with post-viral olfactory dysfunction \> 4 weeks.
• History of positive COVID-19 PCR.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

COVID-19

Interventions

Acupuncture Therapy; Budesonide; Olfactory Training

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Janalee K. Stokken, M.D.
• Organization: Mayo Clinic

Stokken.Janalee@mayo.edu

507-284-1482

Study Officials

• Janalee Stokken, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 7, 2021
• Study Start: December 7, 2021
• Primary Completion: April 21, 2023
• Study Completion: June 9, 2023
• Last Updated: March 12, 2024
• Results First Posted: March 12, 2024

Record last verified: 2024-02

Locations

US (1)