AnosmiaNCT06423495
Efficacy of Photobiomodulation in the Rehabilitation of Olfactory Dysfunctions Induced by Long COVID-19
A study testing low-intensity laser treatment in people with Anosmia and Ageusia, run by Gaffree & Guinle Universitary Hospital at 1 site in Brazil.
Trial summary
On January 30, 2020, the WHO (World Health Organization) declared the new coronavirus pandemic as the sixth public health emergency of international concern. In February 2020, the virus was designated by the Coronavirus Study Group of the International Committee on Virus Taxonomy as severe acute respiratory syndrome… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- What is being tested?
- low-intensity laser treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Jun 2022to 22 Dec 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who complained of loss of smell and taste more than 6 months after COVID-19 infection, aged 18 years or older, with proof of infection by PCR, will be included in the study.
Who cannot join
- Patients with comorbidities prior to COVID-19 infection that could interfere with the functions of smell and taste will be excluded from the study; patients with a history of head and neck cancer, epileptic patients; mouth breathing patients; and pregnant women.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
university hospital Gafree Guinle
Rio de Janeiro, 20270004
DEBORAH S SALES, PHD, +5521982161520, deborahsales.fono@gmail.com
About this study
On January 30, 2020, the WHO (World Health Organization) declared the new coronavirus pandemic as the sixth public health emergency of international concern. In February 2020, the virus was designated by the Coronavirus Study Group of the International Committee on Virus Taxonomy as severe acute respiratory syndrome coronavirus 2. Many reports have described the appearance of olfactory or gustatory dysfunction simultaneously with other pre-established symptoms of COVID-19. Symptoms such as loss of taste or smell may appear 2 to 14 days after being infected with COVID-19. Worldwide, evidence regarding anosmia (loss of smell) and dysgeusia (change in taste) has been associated with COVID-19 infection. OBJECTIVES: To evaluate the effectiveness of low-intensity laser in treating changes in smell and taste after COVID-19 infection and map which changes obtained the best results. MATERIAL AND METHODS: This is an intervention study whose sample will consist of 30 individuals with loss of smell and taste for more than 6 months after COVID-19 infection, aged 18 years or older.
Read the detailed description
objective: To evaluate the effectiveness of low-intensity laser in resolving chemosensory symptoms caused by COVID-19.
This is an intervention study. The sample will consist of 30 individuals who will be allocated to the low-intensity laser treatment group.
The patients will come from research at the COVID-19 outpatient clinic at the Gafree Guinle University Hospital - UNIRIO. Patients who agree to participate in the study will be informed about the objective of the research and will sign an informed consent form.
- Conditions
- Anosmia, Ageusia, COVID-19, Rehabilitation, Laser Therapy
- Being tested
- low-intensity laser treatment
- Keywords
- Anosmia, ageusia, COVID-19, Rehabilitation, Photobiomodulation
- Medical subject headings
- Anosmia, Ageusia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-intensity laser treatmentDevice
The experimental group will be subjected to a total of up to 24 sessions (2x a week for up to 12 weeks) of irradiation with red and infrared laser pulsed radiation, with 820mm wavelength, 60w power and 6 energy cages, applied in both nostrils and in 10 points under the tongue.
| Study group | Role | What they receive |
|---|---|---|
| low-intensity laser treatment group | Experimental | This is an intervention study. The sample will consist of 30 individuals who will be allocated to the low-intensity laser treatment group. Receives: Device: low-intensity laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of low-intensity laser in the treatment of olfactory dysfunction in long term covid-19
evaluate the effectiveness of low-intensity laser
Measured: 20 minutes session with photobiomodulation therapy twice a week, for a total of 16 sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start5 Jun 2022
- Primary completion22 Dec 2023
- Study completion22 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnosmiaStudies 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
- Not applicable
- Intervention model
- Sequential
- Model description
- The sample will consist of 30 individuals who will be allocated to the low-intensity laser treatment group.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaffree & Guinle Universitary Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Principal investigator, Deborah Santos Sales, Gaffree & Guinle Universitary Hospital
- Investigators
- Claudia CF Vasconcelos, PHD, Study director, federal university of the state of rio de janeiro - UNIRIOMariana B Hammerle, MD, Study chair, University hospital Gafree Guinle - UNIRIODEBORAH SANTOS SALES, PHD, Principal investigator, University hospital Gafree Guinle - UNIRIO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423495
- Sponsor's protocol ID
- GaffreeGuinleUH
- Status last verified
- May 2024
- First submitted
- 22 Feb 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hammerle MB, Sales DS, Pinheiro PG, Gouvea EG, de Almeida PIFM, de Araujo Davico C, Souza RS, Spedo CT, Nicaretta DH, Alvarenga RMP, Pires KL, Thuler LCS, Vasconcelos CCF. Cognitive Complaints Assessment and Neuropsychiatric Disorders After Mild COVID-19 Infection. Arch Clin Neuropsychol. 2023 Feb 18;38(2):196-204. doi: 10.1093/arclin/acac093.
PubMed 36464245Vasconcelos CCF, Hammerle MB, Sales DS, Rueda Lopes FC, Pinheiro PG, Gouvea EG, Alves MCDF, Pereira TV, Schmidt SL, Alvarenga RMP, Pires KL. Post-COVID-19 olfactory dysfunction: carbamazepine as a treatment option in a series of cases. J Neurovirol. 2022 Apr;28(2):312-318. doi: 10.1007/s13365-022-01066-3. Epub 2022 Apr 2.
PubMed 35366736
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Photobiomodulation in the Rehabilitation of Olfactory Dysfunctions Induced by Long COVID-19
- ClinicalTrials.gov ID
- NCT06423495
- Acronym / sponsor ID
- GaffreeGuinleUH
- Conditions
- Anosmia, Ageusia, COVID-19, Rehabilitation, Laser Therapy
- Keywords
- Anosmia, ageusia, COVID-19, Rehabilitation, Photobiomodulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gaffree & Guinle Universitary HospitalUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2024 (estimated)
- First posted
- 21 May 2024 (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.
On January 30, 2020, the WHO (World Health Organization) declared the new coronavirus pandemic as the sixth public health emergency of international concern. In February 2020, the virus was designated by the Coronavirus Study Group of the International Committee on Virus Taxonomy as severe acute respiratory syndrome coronavirus 2. Many reports have described the appearance of olfactory or gustatory dysfunction simultaneously with other pre-established symptoms of COVID-19. Symptoms such as loss of taste or smell may appear 2 to 14 days after being infected with COVID-19. Worldwide, evidence regarding anosmia (loss of smell) and dysgeusia (change in taste) has been associated with COVID-19 infection. OBJECTIVES: To evaluate the effectiveness of low-intensity laser in treating changes in smell and taste after COVID-19 infection and map which changes obtained the best results. MATERIAL AND METHODS: This is an intervention study whose sample will consist of 30 individuals with loss of smell and taste for more than 6 months after COVID-19 infection, aged 18 years or older.
Detailed description
objective: To evaluate the effectiveness of low-intensity laser in resolving chemosensory symptoms caused by COVID-19.
This is an intervention study. The sample will consist of 30 individuals who will be allocated to the low-intensity laser treatment group.
The patients will come from research at the COVID-19 outpatient clinic at the Gafree Guinle University Hospital - UNIRIO. Patients who agree to participate in the study will be informed about the objective of the research and will sign an informed consent form.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The sample will consist of 30 individuals who will be allocated to the low-intensity laser treatment group.
| Arm | Type | Receives |
|---|---|---|
| low-intensity laser treatment group | Experimental | Device: low-intensity laser treatmentThis is an intervention study. The sample will consist of 30 individuals who will be allocated to the low-intensity laser treatment group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who complained of loss of smell and taste more than 6 months after COVID-19 infection, aged 18 years or older, with proof of infection by PCR, will be included in the study.
Key exclusion criteria (1 listed)
- Patients with comorbidities prior to COVID-19 infection that could interfere with the functions of smell and taste will be excluded from the study; patients with a history of head and neck cancer, epileptic patients; mouth breathing patients; and pregnant women.
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 |
|---|---|---|
| low-intensity laser treatmentThe experimental group will be subjected to a total of up to 24 sessions (2x a week for up to 12 weeks) of irradiation with red and infrared laser pulsed radiation, with 820mm wavelength, 60w power and 6 energy cages, applied in both nostrils and in 10 points under the tongue. | Device | low-intensity laser treatment group |
Primary outcome
effectiveness of low-intensity laser in the treatment of olfactory dysfunction in long term covid-19
Time frame: 20 minutes session with photobiomodulation therapy twice a week, for a total of 16 sessions
evaluate the effectiveness of low-intensity laser
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Background: PubMed 36464245Hammerle MB, Sales DS, Pinheiro PG, Gouvea EG, de Almeida PIFM, de Araujo Davico C, Souza RS, Spedo CT, Nicaretta DH, Alvarenga RMP, Pires KL, Thuler LCS, Vasconcelos CCF. Cognitive Complaints Assessment and Neuropsychiatric Disorders After Mild COVID-19 Infection. Arch Clin Neuropsychol. 2023 Feb 18;38(2):196-204. doi: 10.1093/arclin/acac093.
- Results publication: PubMed 35366736Vasconcelos CCF, Hammerle MB, Sales DS, Rueda Lopes FC, Pinheiro PG, Gouvea EG, Alves MCDF, Pereira TV, Schmidt SL, Alvarenga RMP, Pires KL. Post-COVID-19 olfactory dysfunction: carbamazepine as a treatment option in a series of cases. J Neurovirol. 2022 Apr;28(2):312-318. doi: 10.1007/s13365-022-01066-3. Epub 2022 Apr 2.
- Post-COVID-19 Olfactory and Gustatory Dysfunction: Photobiomodulation Therapy as a Treatment Option in a Series of CasesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Claudia CF Vasconcelos, PHD study director
federal university of the state of rio de janeiro - UNIRIO
Mariana B Hammerle, MD study chair
University hospital Gafree Guinle - UNIRIO
DEBORAH SANTOS SALES, PHD principal investigator
University hospital Gafree Guinle - UNIRIO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-intensity laser treatment in people with Anosmia and Ageusia, run by Gaffree & Guinle Universitary Hospital 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 1 inclusion and 1 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 May 2024. 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?
Contact DEBORAH S SALES, phd (+5521982161520, deborahsales.fono@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of low-intensity laser in the treatment of olfactory dysfunction in long term covid-19 (time frame: 20 minutes session with photobiomodulation therapy twice a week, for a total of 16 sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06423495, which also lists 2 linked publications.
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 May 2024.