Anosmia Rehabilitation in Patients Post Coronavirus Disease (COVID 19)

August 29, 2022 updated by: Lawson Health Research Institute

Olfactory Retraining Therapy and Budesonide Nasal Rinse for Anosmia Treatment in Patients Post-CoVID 19. A Randomized Controlled Trial

The study will be a randomized controlled trial, involving patients with hyposmia/anosmia of onset immediately after an upper respiratory viral illness, assigned to three distinct study arms. Nasal irrigations will be prescribed to all three groups (BID). In addition, one arm will receive a paper hand-out about post-viral anosmia with instructions to smell common household items (current care) and act as a control group. The second group will receive an essential oil retraining kit, whereas the third group will receive the same olfactory training kit and a prescription to use budesonide with the nasal irrigations. Olfactory scores will be tested at the enrollment, 3 months and at 6 months.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N5A 4V2
        • St. Joseph's Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults 18 years of age or older
  • Hyposmia/anosmia of onset immediately after an upper respiratory viral illness confirmed on Snap n' Sniff threshold testing,
  • Capable, in the opinion of the primary investigator, of providing informed consent to participate in the study. Participants are required to sign an informed consent form indicating they understand the purpose and nature of the study, and that they are willing to participate.

Exclusion Criteria:

  • active cigarette smoker
  • chronic rhinosinusitis
  • head trauma with loss of consciousness
  • inability to read/understand English
  • previous hyposmia/anosmia complaint
  • pregnancy
  • previous sinus
  • skull base or brain surgery
  • current participation in another clinical trial at the time of initial visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control Group
The participants, randomly assigned to this arm, will receive a paper hand-out about post-viral anosmia with instructions to smell common household items (current care). Besides, it will be prescribed nasal irrigation twice a day.
Other: smell household Items
Participants will receive a paper hand-out about post-viral anosmia with instructions to smell common household items
Other: Nasal Irrigation
Participants from all three groups will use nasal rinse (NeilMed Sinus Rinse) two times a day.
Other Names:
  • Nasal Rinse
Experimental: Olfactory Retraining Group
The participants, randomly assigned to this arm, will receive instructions on olfactory retraining and will also be given an essential oil retraining kit, which they will use twice a day. Besides, it will be prescribed nasal irrigation twice a day.
Other: Nasal Irrigation
Participants from all three groups will use nasal rinse (NeilMed Sinus Rinse) two times a day.
Other Names:
  • Nasal Rinse
Other: Olfactory retraining
Olfactory retraining Olfactory training is performed by exposing patients twice daily to essential oils with four specific odors, present in glass jars with soaked cotton pads: phenyl ethyl alcohol, rose; eucalyptol, eucalyptus; citronellal, lemon; eugenol, cloves.
Other Names:
  • essential oils kit
  • smell training
Experimental: Olfactory Retraining_Budesonide Group
The participants, randomly assigned to this arm, will receive instructions on olfactory retraining, the olfactory training kit and it will be prescribed nasal irrigation with Budesonise, twice a day.
Other: Olfactory retraining
Olfactory retraining Olfactory training is performed by exposing patients twice daily to essential oils with four specific odors, present in glass jars with soaked cotton pads: phenyl ethyl alcohol, rose; eucalyptol, eucalyptus; citronellal, lemon; eugenol, cloves.
Other Names:
  • essential oils kit
  • smell training
Drug: corticosteroid nasal irrigation
Nasal irrigation with corticosteroid (budesonide) consists of 240-mL nasal irrigation with Pulmicort Respules (0.5mg) across both nose sides via NeilMed Sinus Rinse bottle (Santa Rosa, California, USA).
Other Names:
  • Budesonide nasal irrigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Snap and Sniff Threshold Test at 3 months
Time Frame: 3 months
Score from the Snap and Sniff Olfactory Test results
3 months
Change from baseline Smell Identification Test (SIT) at 3 months
Time Frame: 3 months
Score from the Smell Identification test results.
3 months
Change from Baseline Snap and Sniff Threshold Test at 6 months
Time Frame: 6 months
Score from the Snap and Sniff Olfactory Test results
6 months
Change from baseline Smell Identification Test (SIT) at 6 months
Time Frame: 6 months
Score from the Smell Identification test results.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline QOD-NS at 3 months
Time Frame: 3 months
Scores from the short version of the Questionnaire of Olfactory Disorders Negative Statements (QOD-NS)
3 months
Change from baseline SF-36 health survey at 3 months
Time Frame: 3 months
Short Form 36 Health Survey scores
3 months
Change from baseline QOD-NS at 6 months
Time Frame: 6 months
Scores from the short version of the Questionnaire of Olfactory Disorders Negative Statements (QOD-NS)
6 months
Change from baseline SF-36 health survey at 6 months
Time Frame: 6 months
Short Form 36 Health Survey scores
6 months
Adherence to the Study Protocol
Time Frame: 6 months
Adherence comparison between participants post-CoVID 19 and patients post other viral infections.
6 months
Recovery
Time Frame: 6 months
Compare the rate of recovery between post-COVID 19 patients and patients post other viral infections.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Leigh Sowerby, MD, FRCSC, Western University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 10, 2021

Primary Completion (Anticipated)

December 10, 2021

Study Completion (Anticipated)

March 10, 2022

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

May 1, 2020

First Posted (Actual)

May 5, 2020

Study Record Updates

Last Update Posted (Actual)

August 30, 2022

Last Update Submitted That Met QC Criteria

August 29, 2022

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anosmia_CoVID 19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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