Acupuncture Therapy for COVID-Related Olfactory Loss

NCT ID: NCT04952389

Last Updated: 2024-03-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-07

Study Completion Date

2023-06-09

Brief Summary

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

Detailed Description

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Conditions

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Olfactory Dysfunction COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acupuncture Therapy Group

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

Group Type EXPERIMENTAL

Acupuncture Therapy

Intervention Type DEVICE

Consists of two treatments per week for five weeks

Budesonide

Intervention Type DRUG

Twice daily nasal rinses with steroid medication (budesonide)

Olfactory Training

Intervention Type 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)

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.

Group Type ACTIVE_COMPARATOR

Budesonide

Intervention Type DRUG

Twice daily nasal rinses with steroid medication (budesonide)

Olfactory Training

Intervention Type 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)

Interventions

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Acupuncture Therapy

Consists of two treatments per week for five weeks

Intervention Type DEVICE

Budesonide

Twice daily nasal rinses with steroid medication (budesonide)

Intervention Type DRUG

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)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Janalee K. Stokken

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Janalee Stokken, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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21-003531

Identifier Type: -

Identifier Source: org_study_id

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