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

Universidade do Estado do Pará

Status: Unknown

Conditions: Anosmia; SARS-CoV Infection; Covid19; Olfactory Disorder

Treatments: Other: Essence oils

Study type: Interventional

Funder types: Other

Identifiers

NCT04764981

OLFATO001

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 3 patient groups

Experimental Group 1: Essences Oils

Experimental group

Description:

The individuals of this group are 150 individuals with olfactory disorder related to COVID-19 that will be submitted to clinical exams, olfactory test and MRI imaging, after that, participants will undergo an olfactory training with essences oils. Each participant in this group will receive a kit with four 30 ml bottles, each containing a circular piece of watercolor paper soaked in one of the four essences oils (rose, eucalyptus, lemon and cloves) used in olfactory training, a manual to make the olfactory training at home and a self-assessment diary which should be filled weekly. Each participant of this group will use the training kit for three months, the olfactory training consists of inhaling each of the substances for 30 seconds, with an interval of 30 seconds between them, twice a day, upon waking up and before bed, the participants will be reassessed with CCCRT after each month of training. The results of this group will be compared with the other groups.

Treatment:

Other: Essence oils

Experimental Group 2: Clinical follow-up

No Intervention group

Description:

The individuals of this group are 150 individuals with olfactory disorder related to COVID-19. that will be submitted to clinical exams, olfactory test and MRI imaging, after three months they will be reassessed.

Control Group

No Intervention group

Description:

The individuals of this group are 50 healthy individuals, without previous COVID-19 infection, that will be submitted to clinical exams, olfactory test, MRI imaging and the participants will be tested for the ability to identification of the essence oils utilized by Experimental group 1.