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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04764981
Other study ID # OLFATO001
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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