Clinical trial NCT04764981: Olfactory Training for Olfactory Dysfunction After Coronavirus Disease - 19 (COVID-19)
Official title: Clinical Outcomes of Olfactory Training for Treatment of Olfactory Dysfunction After COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
SARS-CoV Infection
Olfactory Disorder
Anosmia
Lead sponsor: Universidade do Estado do Pará
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial study, with 2 experimental groups
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: To Assess the effectiveness of olfactory training therapy in the treatment of persistent olfactory dysfunctions after COVID-19
timeFrame: 4 years
Secondary outcomes:
measure: To Investigate by means of skull nuclear magnetic resonance (MRI) exams for possible neural correlates of olfactory dysfunctions present in post-COVID-19 patients
timeFrame: 4 years
measure: To Measure by means of a standardized olfactory test the olfactory dysfunctions present in post-COVID-19 patients
timeFrame: 4 years
measure: 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
timeFrame: 4 years
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: Unidade de Ensino E Assistência Em Fisioterapia E Terapia Ocupacional
state: PA
Study officials:
References: