Anosmia Rehabilitation in Patients Post Coronavirus Disease (COVID 19)

Olfactory Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04374474
• Other study ID #: Anosmia_CoVID 19
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 10, 2021
• Est. completion date: March 10, 2022

Study information

• Verified date: July 2020
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 10, 2022
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anosmia
• COVID-19
• Olfactory Disorder

Intervention

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.

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:
• smell household Items
Participants will receive a paper hand-out about post-viral anosmia with instructions to smell common household items
• Nasal Irrigation
Participants from all three groups will use nasal rinse (NeilMed Sinus Rinse) two times a day.

Locations

Country	Name	City	State
Canada	St. Joseph's Health Care	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Snap and Sniff Threshold Test at 3 months	Score from the Snap and Sniff Olfactory Test results	3 months
Primary	Change from baseline Smell Identification Test (SIT) at 3 months	Score from the Smell Identification test results.	3 months
Primary	Change from Baseline Snap and Sniff Threshold Test at 6 months	Score from the Snap and Sniff Olfactory Test results	6 months
Primary	Change from baseline Smell Identification Test (SIT) at 6 months	Score from the Smell Identification test results.	6 months
Secondary	Change from baseline QOD-NS at 3 months	Scores from the short version of the Questionnaire of Olfactory Disorders Negative Statements (QOD-NS)	3 months
Secondary	Change from baseline SF-36 health survey at 3 months	Short Form 36 Health Survey scores	3 months
Secondary	Change from baseline QOD-NS at 6 months	Scores from the short version of the Questionnaire of Olfactory Disorders Negative Statements (QOD-NS)	6 months
Secondary	Change from baseline SF-36 health survey at 6 months	Short Form 36 Health Survey scores	6 months
Secondary	Adherence to the Study Protocol	Adherence comparison between participants post-CoVID 19 and patients post other viral infections.	6 months
Secondary	Recovery	Compare the rate of recovery between post-COVID 19 patients and patients post other viral infections.	6 months

External Links

•   Snap and Sniff threshold test informative website