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

Not Applicable

Recruiting

• Conditions: Ageusia; Rehabilitation; Laser Therapy; COVID-19; Anosmia
• Interventions: Device: low-intensity laser treatment

• Registration Number: NCT06423495
• Lead Sponsor: Gaffree & Guinle Universitary Hospital

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.

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 Timeline

• Study Start: 2022-06-05
• Primary Completion: 2023-12-22
• Study First Submitted: 2024-02-22
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-17
• Last Update Submitted: 2024-05-17
• Study First Posted: 2024-05-21
• Last Update Posted: 2024-05-21
• Study Completion: 2024-12-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
low-intensity laser treatment group	low-intensity laser treatment	This is an intervention study. The sample will consist of 30 individuals who will be allocated to the low-intensity laser treatment group.

Primary Outcome Measures

Name	Time	Method
effectiveness of low-intensity laser in the treatment of olfactory dysfunction in long term covid-19	20 minutes session with photobiomodulation therapy twice a week, for a total of 16 sessions	evaluate the effectiveness of low-intensity laser

Trial Locations

Locations (1)

university hospital Gafree Guinle; 🇧🇷 Rio de Janeiro, Brazil