Anosmia Rehabilitation in Patients Post Coronavirus Disease (COVID 19)

Phase 4

Withdrawn

• Conditions: Olfactory Disorder
• Interventions: Other: Olfactory retraining; Other: smell household Items; Other: Nasal Irrigation; Drug: corticosteroid nasal irrigation

• Registration Number: NCT04374474
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-05-01
• Study First Posted: 2020-05-05
• Status Verified: 2020-07
• Study Start: 2021-01-10
• Primary Completion: 2021-12-10
• Study Completion: 2022-03-10
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olfactory Retraining Group	Nasal Irrigation	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.
Control Group	Nasal Irrigation	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.
Olfactory Retraining Group	Olfactory retraining	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.
Olfactory Retraining_Budesonide Group	corticosteroid nasal irrigation	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.
Control Group	smell household Items	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.
Olfactory Retraining_Budesonide Group	Olfactory retraining	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St. Joseph's Health Care; 🇨🇦 London, Ontario, Canada