Acupuncture Therapy for COVID-Related Olfactory Loss

COVID-19 Clinical Trial

Official title:

Acupuncture Therapy for COVID-Related Olfactory Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04952389
• Other study ID #: 21-003531
• Status: Completed
• Phase: N/A
• Start date: December 7, 2021
• Est. completion date: June 9, 2023

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 9, 2023
• Est. primary completion date: April 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Olfactory Dysfunction

Intervention

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)

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline, post-treatment approximately 12 weeks
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.	Baseline, post-treatment approximately 12 weeks
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.	Baseline, post-treatment approximately 12 weeks