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Anosmia Rehabilitation in Patients Post Coronavirus Disease (COVID 19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04374474
Recruitment Status : Not yet recruiting
First Posted : May 5, 2020
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Olfactory Disorder Other: Olfactory retraining Drug: corticosteroid nasal irrigation Other: smell household Items Other: Nasal Irrigation Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Olfactory Retraining Therapy and Budesonide Nasal Rinse for Anosmia Treatment in Patients Post-CoVID 19. A Randomized Controlled Trial
Estimated Study Start Date : January 10, 2021
Estimated Primary Completion Date : December 10, 2021
Estimated Study Completion Date : March 10, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

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 Name: 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: 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

Other: Nasal Irrigation
Participants from all three groups will use nasal rinse (NeilMed Sinus Rinse) two times a day.
Other Name: Nasal Rinse

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 Name: Budesonide nasal irrigation




Primary Outcome Measures :
  1. Change from Baseline Snap and Sniff Threshold Test at 3 months [ Time Frame: 3 months ]
    Score from the Snap and Sniff Olfactory Test results

  2. Change from baseline Smell Identification Test (SIT) at 3 months [ Time Frame: 3 months ]
    Score from the Smell Identification test results.

  3. Change from Baseline Snap and Sniff Threshold Test at 6 months [ Time Frame: 6 months ]
    Score from the Snap and Sniff Olfactory Test results

  4. Change from baseline Smell Identification Test (SIT) at 6 months [ Time Frame: 6 months ]
    Score from the Smell Identification test results.


Secondary Outcome Measures :
  1. 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)

  2. Change from baseline SF-36 health survey at 3 months [ Time Frame: 3 months ]
    Short Form 36 Health Survey scores

  3. 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)

  4. Change from baseline SF-36 health survey at 6 months [ Time Frame: 6 months ]
    Short Form 36 Health Survey scores

  5. Adherence to the Study Protocol [ Time Frame: 6 months ]
    Adherence comparison between participants post-CoVID 19 and patients post other viral infections.

  6. Recovery [ Time Frame: 6 months ]
    Compare the rate of recovery between post-COVID 19 patients and patients post other viral infections.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04374474


Contacts
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Contact: Taciano Rocha 5196466100 ext 61125 taciano.rocha@sjhc.london.on.ca

Locations
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Canada, Ontario
St. Joseph's Health Care
London, Ontario, Canada, N5A 4V2
Contact: Leigh J Sowerby         
Principal Investigator: Leigh J Sowerby, MD         
Sub-Investigator: Brian Rotenberg, MD         
Sub-Investigator: Khrystyna Ioanidi, MD         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Leigh Sowerby, MD, FRCSC Western University
Publications:
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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT04374474    
Other Study ID Numbers: Anosmia_CoVID 19
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020

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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
Keywords provided by Lawson Health Research Institute:
anosmia
hyposmia
CoVID19
post-viral anosmia
snap and sniff olfactory test
budesonide
Additional relevant MeSH terms:
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Olfaction Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists