Olfactory Training for Olfactory Dysfunction After Coronavirus Disease - 19 (COVID-19)

Covid19 Clinical Trial

Official title:

Clinical Outcomes of Olfactory Training for Treatment of Olfactory Dysfunction After COVID-19

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04764981
• Other study ID #: OLFATO001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 2021
• Est. completion date: May 1, 2024

Study information

• Verified date: February 2021
• Source: Universidade do Estado do Pará
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is a randomized controlled clinical trial study that aims to follow a sample of individuals with persistent olfactory dysfunction post-COVID-19. The aim of this study is assess the clinical outcomes of olfactory training therapy in the treatment of persistent olfactory dysfunctions after COVID-19. The sample will consist of 350 participants, being 300 individuals with persistent olfactory dysfunction post-COVID-19 and 50 healthy individuals. Volunteers' will be separated in two experimental groups (1 and 2 ) and a control group. All participants will be submitted to clinical evaluation that include the Connecticut Chemosensory Clinical Research Test (CCCRT), an olfactory test to diagnose anosmia and hyposmia, and two skull Magnetic Resonance imaging (MRI). Only participants of Experimental group 1 will be submitted to an olfactory training with essences oils. Experimental group 2 will only receive a clinical follow-up after three months and control group will be only submitted to neurological exam, olfactory test, MRI imaging and test their ability to discriminate the essence oils used in olfactory training. As a result, is expected a better understanding of the characteristics of olfactory dysfunction caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) virus infection, as well as the effectiveness and viability of using Olfactory Training as a therapeutic alternative.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 350
• Est. completion date: May 1, 2024
• Est. primary completion date: May 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of COVID-19 by Real Time Polymerase chain-reaction for SARS-CoV-2 or serological tests for SARS-CoV-2 antigens.\
• Olfactory dysfunction confirmed by Connecticut Chemosensory Clinical Research Test (CCCRC-T).

Exclusion Criteria:

• Smokers
• Individuals with diagnosed rhinitis
• Individuals with diagnosed Neurological diseases
• Individuals submitted to brain surgery
• Previous historic of hyposmia and/ or anosmia
• Pregnancy
• Allergy to any of the substances present in the olfactory test kit
• Individuals who are undergoing another treatment for olfactory dysfunction

Related Conditions & MeSH terms

• Anosmia
• Coronavirus Infections
• Covid19
• Olfaction Disorders
• Olfactory Disorder
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Other:
• Essence oils
Consists in olfactory training using essence oils

Locations

Country	Name	City	State
Brazil	Unidade de Ensino E Assistência Em Fisioterapia E Terapia Ocupacional	Belém	PA

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Estado do Pará

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Assess the effectiveness of olfactory training therapy in the treatment of persistent olfactory dysfunctions after COVID-19	The individuals of Experimental group 1 will be submitted to a olfactory training with essence oils, the participants will be reassessed with Olfactory test CCCRT monthly and this results will be compared with the reassessment results of the Experimental group 2 (no intervention group). The results of CCCRT of these two groups will be compared with Control group. The CCCRT olfactory test consists of n-butanol smell threshold test and smell identification test. Olfactory function score will be assessed (0: worst score; 7: best score).	4 years
Secondary	To Investigate by means of skull nuclear magnetic resonance (MRI) exams for possible neural correlates of olfactory dysfunctions present in post-COVID-19 patients	MRI imaging of olfactory bulb will be assessed in the individuals of this study, for better understanding of possible lesions at neural sites	4 years
Secondary	To Measure by means of a standardized olfactory test the olfactory dysfunctions present in post-COVID-19 patients	CCCRT will be used to classify individuals as having normosmia, hyposmia or anosmia	4 years
Secondary	Propose an olfactory training protocol appropriate to the demands of patients with post-COVID-19 olfactory dysfunction and in accordance with the reality of Brazilian public health services	The olfactory training using essence oils will be tested in this study as a low cost alternative for therapeutics	4 years