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OpenTrials
Completed

NCT Number: NCT04952389

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.

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Key information

Conditions

Olfactory Dysfunction COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture Therapy

Device

Consists of two treatments per week for five weeks

Budesonide

Drug

Twice daily nasal rinses with steroid medication (budesonide)

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Patient-reported Subjective Olfactory Loss

    Time frame: Baseline, post-treatment approximately 12 weeks

    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.

  2. Change in Sino-Nasal Outcome Test (SNOT-22)

    Time frame: 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, with a total score ranging of 0-110, lower scores indicate no problem and higher scores indicate more problem.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2021
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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