Olfactory Training for Olfactory Dysfunction After Coronavirus Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-31

Study Completion Date

2024-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Covid19 SARS-CoV Infection Olfactory Disorder Anosmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled clinical trial study, with 2 experimental groups

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Experimental Group 1: Essences Oils

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.

Group Type EXPERIMENTAL

Essence oils

Intervention Type OTHER

Consists in olfactory training using essence oils

Experimental Group 2: Clinical follow-up

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Essence oils

Consists in olfactory training using essence oils

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes