Covid19NCT04764981
Olfactory Training for Olfactory Dysfunction After Coronavirus Disease - 19 (COVID-19)
A study testing Essence oils in people with Covid19 and SARS-CoV Infection, run by Universidade do Estado do Pará at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, SARS-CoV Infection, Olfactory Disorder
- What is being tested?
- Essence oils
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteBrazil
- Study dates
- May 2021to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Brazil1 site
Unidade de Ensino E Assistência Em Fisioterapia E Terapia Ocupacional
Belém, Pará, 66095-661
About this study
Official title: Clinical Outcomes of Olfactory Training for Treatment of Olfactory Dysfunction After COVID-19
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.
- Conditions
- Covid19, SARS-CoV Infection, Olfactory Disorder, Anosmia
- Being tested
- Essence oils
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essence oilsOther
Consists in olfactory training using essence oils
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1: Essences Oils | Experimental | 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. Receives: Other: Essence oils |
| Experimental Group 2: Clinical follow-up | No intervention | 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 | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 years
Secondary outcomes (3)
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
Measured: 4 years
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
Measured: 4 years
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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study startMay 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial study, with 2 experimental groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Estado do Pará
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALNA CAROLINA MENDES PARANHOS, Universidade do Estado do Pará
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764981
- Sponsor's protocol ID
- OLFATO001
- Status last verified
- Feb 2021
- First submitted
- 14 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Olfactory Training for Treatment of Olfactory Dysfunction After COVID-19
- ClinicalTrials.gov ID
- NCT04764981
- Acronym / sponsor ID
- OLFATO001
- Conditions
- Covid19, SARS-CoV Infection, Olfactory Disorder, Anosmia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Universidade do Estado do ParáUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled clinical trial study, with 2 experimental groups
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1: Essences Oils | Experimental | Other: Essence oilsThe 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. |
| Experimental Group 2: Clinical follow-up | No intervention | –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 | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (8 listed)
- Smokers
- Individuals with diagnosed rhinitis
- Individuals with diagnosed Neurological diseases
- Individuals submitted to brain surgery
- Previous historic of hyposmia and/ or anosmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Essence oilsConsists in olfactory training using essence oils | Other | Experimental Group 1: Essences Oils |
Primary outcome
To Assess the effectiveness of olfactory training therapy in the treatment of persistent olfactory dysfunctions after COVID-19
Time frame: 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).
3 secondary outcomes
To Investigate by means of skull nuclear magnetic resonance (MRI) exams for possible neural correlates of olfactory dysfunctions present in post-COVID-19 patients
Time frame: 4 years
To Measure by means of a standardized olfactory test the olfactory dysfunctions present in post-COVID-19 patients
Time frame: 4 years
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
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essence oils in people with Covid19 and SARS-CoV Infection, run by Universidade do Estado do Pará at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Assess the effectiveness of olfactory training therapy in the treatment of persistent olfactory dysfunctions after COVID-19 (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.