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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

Tracking Information
First Submitted Date  ICMJE April 29, 2020
First Posted Date  ICMJE May 5, 2020
Last Update Posted Date July 16, 2020
Estimated Study Start Date  ICMJE January 10, 2021
Estimated Primary Completion Date December 10, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2020)
  • Change from Baseline Snap and Sniff Threshold Test at 3 months [ Time Frame: 3 months ]
    Score from the Snap and Sniff Olfactory Test results
  • Change from baseline Smell Identification Test (SIT) at 3 months [ Time Frame: 3 months ]
    Score from the Smell Identification test results.
  • Change from Baseline Snap and Sniff Threshold Test at 6 months [ Time Frame: 6 months ]
    Score from the Snap and Sniff Olfactory Test results
  • Change from baseline Smell Identification Test (SIT) at 6 months [ Time Frame: 6 months ]
    Score from the Smell Identification test results.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2020)
  • 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)
  • Change from baseline SF-36 health survey at 3 months [ Time Frame: 3 months ]
    Short Form 36 Health Survey scores
  • 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)
  • Change from baseline SF-36 health survey at 6 months [ Time Frame: 6 months ]
    Short Form 36 Health Survey scores
  • Adherence to the Study Protocol [ Time Frame: 6 months ]
    Adherence comparison between participants post-CoVID 19 and patients post other viral infections.
  • Recovery [ Time Frame: 6 months ]
    Compare the rate of recovery between post-COVID 19 patients and patients post other viral infections.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anosmia Rehabilitation in Patients Post Coronavirus Disease (COVID 19)
Official Title  ICMJE Olfactory Retraining Therapy and Budesonide Nasal Rinse for Anosmia Treatment in Patients Post-CoVID 19. A Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Olfactory Disorder
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: smell household Items
    • Other: Nasal Irrigation
  • 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.
    Interventions:
    • Other: Olfactory retraining
    • Other: Nasal Irrigation
  • 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.
    Interventions:
    • Other: Olfactory retraining
    • Drug: corticosteroid nasal irrigation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 1, 2020)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 10, 2022
Estimated Primary Completion Date December 10, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Taciano Rocha 5196466100 ext 61125 taciano.rocha@sjhc.london.on.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04374474
Other Study ID Numbers  ICMJE Anosmia_CoVID 19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leigh Sowerby, MD, FRCSC Western University
PRS Account Lawson Health Research Institute
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP