Anosmia, Covid19, Olfactory Disorder, SARS-CoV Infection
Conditions
Brief 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.
Interventions
OTHEREssence oils
Consists in olfactory training using essence oils
Sponsors
Universidade do Estado do Pará
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants of groups will be evaluated and random inserted in one of the experimental groups. The person responsible for reassessment will be blinded for which group the individual reassessed came from.
Intervention model description
Randomized controlled clinical trial study, with 2 experimental groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Assess the effectiveness of olfactory training therapy in the treatment of persistent olfactory dysfunctions after COVID-19 | 4 years | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Investigate by means of skull nuclear magnetic resonance (MRI) exams for possible neural correlates of olfactory dysfunctions present in post-COVID-19 patients | 4 years | MRI imaging of olfactory bulb will be assessed in the individuals of this study, for better understanding of possible lesions at neural sites |
| To Measure by means of a standardized olfactory test the olfactory dysfunctions present in post-COVID-19 patients | 4 years | CCCRT will be used to classify individuals as having normosmia, hyposmia or anosmia |
| 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 | 4 years | The olfactory training using essence oils will be tested in this study as a low cost alternative for therapeutics |
Countries
Brazil
Outcome results
None listed