Efficacy of Photobiomodulation in the Rehabilitation of Olfactory Dysfunctions Induced by Long COVID-19

NCT06423495 | Recruiting

• 1 other identifier: GaffreeGuinleUH
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Anosmia; Ageusia; COVID-19; Rehabilitation; Laser Therapy

Keywords

Anosmia; ageusia; COVID-19; Rehabilitation; Photobiomodulation

Outcome Measures

Primary Outcomes (1)

• effectiveness of low-intensity laser in the treatment of olfactory dysfunction in long term covid-19

  evaluate the effectiveness of low-intensity laser

  20 minutes session with photobiomodulation therapy twice a week, for a total of 16 sessions

Study Arms (1)

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.

Device: low-intensity laser treatment

Interventions

low-intensity laser treatment DEVICE

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.

low-intensity laser treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gaffree & Guinle Universitary Hospital: lead
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator

Study Sites (1)

university hospital Gafree Guinle

Rio de Janeiro, 20270004, Brazil

RECRUITING

Related Publications (2)

• 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.

  PMID: 36464245 BACKGROUND

• Vasconcelos 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.

  PMID: 35366736 RESULT

Related Links

• Post-COVID-19 Olfactory and Gustatory Dysfunction: Photobiomodulation Therapy as a Treatment Option in a Series of Cases

MeSH Terms

Conditions

Anosmia; Ageusia; COVID-19

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Taste Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Claudia CF Vasconcelos, PHD

  federal university of the state of rio de janeiro - UNIRIO

  STUDY DIRECTOR

• Mariana B Hammerle, MD

  University hospital Gafree Guinle - UNIRIO

  STUDY CHAIR

• DEBORAH SANTOS SALES, PHD

  University hospital Gafree Guinle - UNIRIO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DEBORAH S SALES, phd

CONTACT

+5521982161520; deborahsales.fono@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deborah Santos Sales

Model Details: The sample will consist of 30 individuals who will be allocated to the low-intensity laser treatment group.

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: May 21, 2024
• Study Start: June 5, 2022
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

BR (1)