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

Primary Purpose

Covid19, SARS-CoV Infection, Olfactory Disorder

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Essence oils
Sponsored by
Universidade do Estado do Pará
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Unidade de Ensino E Assistência Em Fisioterapia E Terapia Ocupacional

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Experimental Group 1: Essences Oils

Experimental Group 2: Clinical follow-up

Control Group

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
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
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

Full Information

First Posted
February 14, 2021
Last Updated
February 18, 2021
Sponsor
Universidade do Estado do Pará
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1. Study Identification

Unique Protocol Identification Number
NCT04764981
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 2021 (Anticipated)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Estado do Pará

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, SARS-CoV Infection, Olfactory Disorder, Anosmia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical trial study, with 2 experimental groups
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group 1: Essences Oils
Arm Type
Experimental
Arm 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.
Arm Title
Experimental Group 2: Clinical follow-up
Arm Type
No Intervention
Arm 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.
Arm Title
Control Group
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Essence oils
Intervention Description
Consists in olfactory training using essence oils
Primary Outcome Measure Information:
Title
To Assess the effectiveness of olfactory training therapy in the treatment of persistent olfactory dysfunctions after COVID-19
Description
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).
Time Frame
4 years
Secondary Outcome Measure Information:
Title
To Investigate by means of skull nuclear magnetic resonance (MRI) exams for possible neural correlates of olfactory dysfunctions present in post-COVID-19 patients
Description
MRI imaging of olfactory bulb will be assessed in the individuals of this study, for better understanding of possible lesions at neural sites
Time Frame
4 years
Title
To Measure by means of a standardized olfactory test the olfactory dysfunctions present in post-COVID-19 patients
Description
CCCRT will be used to classify individuals as having normosmia, hyposmia or anosmia
Time Frame
4 years
Title
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
Description
The olfactory training using essence oils will be tested in this study as a low cost alternative for therapeutics
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Unidade de Ensino E Assistência Em Fisioterapia E Terapia Ocupacional
City
Belém
State/Province
PA
ZIP/Postal Code
66095-661
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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