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Anosmia Rehabilitation in Patients Post Coronavirus Disease (COVID 19)

Primary Purpose

Olfactory Disorder

Status
Withdrawn
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Olfactory retraining
corticosteroid nasal irrigation
smell household Items
Nasal Irrigation
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Olfactory Disorder focused on measuring anosmia, hyposmia, CoVID19, post-viral anosmia, snap and sniff olfactory test, budesonide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Health Care

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

Control Group

Olfactory Retraining Group

Olfactory Retraining_Budesonide Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 29, 2020
Last Updated
August 29, 2022
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04374474
Brief Title
Anosmia Rehabilitation in Patients Post Coronavirus Disease (COVID 19)
Official Title
Olfactory Retraining Therapy and Budesonide Nasal Rinse for Anosmia Treatment in Patients Post-CoVID 19. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Study withdrawn before any enrollment (site's research goals adjustments).
Study Start Date
January 10, 2021 (Anticipated)
Primary Completion Date
December 10, 2021 (Anticipated)
Study Completion Date
March 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Olfactory Disorder
Keywords
anosmia, hyposmia, CoVID19, post-viral anosmia, snap and sniff olfactory test, budesonide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Olfactory Retraining Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Olfactory Retraining_Budesonide Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Olfactory retraining
Other Intervention Name(s)
essential oils kit, smell training
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
corticosteroid nasal irrigation
Other Intervention Name(s)
Budesonide nasal irrigation
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
smell household Items
Intervention Description
Participants will receive a paper hand-out about post-viral anosmia with instructions to smell common household items
Intervention Type
Other
Intervention Name(s)
Nasal Irrigation
Other Intervention Name(s)
Nasal Rinse
Intervention Description
Participants from all three groups will use nasal rinse (NeilMed Sinus Rinse) two times a day.
Primary Outcome Measure Information:
Title
Change from Baseline Snap and Sniff Threshold Test at 3 months
Description
Score from the Snap and Sniff Olfactory Test results
Time Frame
3 months
Title
Change from baseline Smell Identification Test (SIT) at 3 months
Description
Score from the Smell Identification test results.
Time Frame
3 months
Title
Change from Baseline Snap and Sniff Threshold Test at 6 months
Description
Score from the Snap and Sniff Olfactory Test results
Time Frame
6 months
Title
Change from baseline Smell Identification Test (SIT) at 6 months
Description
Score from the Smell Identification test results.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline QOD-NS at 3 months
Description
Scores from the short version of the Questionnaire of Olfactory Disorders Negative Statements (QOD-NS)
Time Frame
3 months
Title
Change from baseline SF-36 health survey at 3 months
Description
Short Form 36 Health Survey scores
Time Frame
3 months
Title
Change from baseline QOD-NS at 6 months
Description
Scores from the short version of the Questionnaire of Olfactory Disorders Negative Statements (QOD-NS)
Time Frame
6 months
Title
Change from baseline SF-36 health survey at 6 months
Description
Short Form 36 Health Survey scores
Time Frame
6 months
Title
Adherence to the Study Protocol
Description
Adherence comparison between participants post-CoVID 19 and patients post other viral infections.
Time Frame
6 months
Title
Recovery
Description
Compare the rate of recovery between post-COVID 19 patients and patients post other viral infections.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leigh Sowerby, MD, FRCSC
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Health Care
City
London
State/Province
Ontario
ZIP/Postal Code
N5A 4V2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18677645
Citation
Vennemann MM, Hummel T, Berger K. The association between smoking and smell and taste impairment in the general population. J Neurol. 2008 Aug;255(8):1121-6. doi: 10.1007/s00415-008-0807-9. Epub 2008 Jul 28.
Results Reference
background
PubMed Identifier
24429163
Citation
Croy I, Nordin S, Hummel T. Olfactory disorders and quality of life--an updated review. Chem Senses. 2014 Mar;39(3):185-94. doi: 10.1093/chemse/bjt072. Epub 2014 Jan 15.
Results Reference
background
PubMed Identifier
24114690
Citation
Konstantinidis I, Tsakiropoulou E, Bekiaridou P, Kazantzidou C, Constantinidis J. Use of olfactory training in post-traumatic and postinfectious olfactory dysfunction. Laryngoscope. 2013 Dec;123(12):E85-90. doi: 10.1002/lary.24390. Epub 2013 Oct 4.
Results Reference
background
PubMed Identifier
29901865
Citation
Nguyen TP, Patel ZM. Budesonide irrigation with olfactory training improves outcomes compared with olfactory training alone in patients with olfactory loss. Int Forum Allergy Rhinol. 2018 Sep;8(9):977-981. doi: 10.1002/alr.22140. Epub 2018 Jun 14.
Results Reference
background
PubMed Identifier
31430061
Citation
Mattos JL, Edwards C, Schlosser RJ, Hyer M, Mace JC, Smith TL, Soler ZM. A brief version of the questionnaire of olfactory disorders in patients with chronic rhinosinusitis. Int Forum Allergy Rhinol. 2019 Oct;9(10):1144-1150. doi: 10.1002/alr.22392. Epub 2019 Aug 20.
Results Reference
background
Links:
URL
https://sensonics.com/product/snap-sniff-odor-threshold-test/
Description
Snap and Sniff threshold test informative website

Learn more about this trial

Anosmia Rehabilitation in Patients Post Coronavirus Disease (COVID 19)

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