## Protocol Section
### Identification Module
**NCT ID:** NCT06423495

**Brief Title:** Efficacy of Photobiomodulation in the Rehabilitation of Olfactory Dysfunctions Induced by Long COVID-19

**Official Title:** Efficacy of Photobiomodulation in the Rehabilitation of Olfactory Dysfunctions Induced by Long COVID-19

#### Organization Study ID Info
**ID:** GaffreeGuinleUH
#### Organization
**Class:** OTHER
**Full Name:** Gaffree & Guinle Universitary Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-22

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2023-12-22

**Type:** ACTUAL

#### Start Date
**Date:** 2022-06-05

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-22
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Rio de Janeiro State Research Supporting Foundation (FAPERJ)

#### Lead Sponsor

**Class:** OTHER

**Name:** Gaffree & Guinle Universitary Hospital

#### Responsible Party

**Investigator Affiliation:** Gaffree & Guinle Universitary Hospital

**Investigator Full Name:** Deborah Santos Sales

**Investigator Title:** Deborah Santos Sales

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Anosmia

- Ageusia

- COVID-19

- Rehabilitation

- Laser Therapy

**Keywords:**

- Anosmia

- ageusia

- COVID-19

- Rehabilitation

- Photobiomodulation

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SEQUENTIAL

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

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: low-intensity laser treatment

**Label:** low-intensity laser treatment group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- low-intensity laser treatment group

**Description:** 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.

**Name:** low-intensity laser treatment

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** evaluate the effectiveness of low-intensity laser

**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

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** deborahsales.fono@gmail.com

**Name:** DEBORAH S SALES, phd

**Phone:** +5521982161520

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Rio de Janeiro

**Contacts:**

***Contact 1:***

- **Email:** deborahsales.fono@gmail.com

- **Name:** DEBORAH S SALES, PHD

- **Phone:** +5521982161520

- **Role:** CONTACT

**Country:** Brazil

**Facility:** university hospital Gafree Guinle

**Status:** RECRUITING

**Zip:** 20270004

#### Overall Officials

**Official 1:**

**Affiliation:** federal university of the state of rio de janeiro - UNIRIO

**Name:** Claudia CF Vasconcelos, PHD

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** University hospital Gafree Guinle - UNIRIO

**Name:** Mariana B Hammerle, MD

**Role:** STUDY_CHAIR

**Official 3:**

**Affiliation:** University hospital Gafree Guinle - UNIRIO

**Name:** DEBORAH SANTOS SALES, PHD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** 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

**Citation:** 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

#### See Also Links

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

**URL:** https://openneurologyjournal.com/VOLUME/17/ELOCATOR/e1874205X2309190/FULLTEXT/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000011014

- Term: Pneumonia

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000018352

- Term: Coronavirus Infections

- ID: D000003333

- Term: Coronaviridae Infections

- ID: D000030341

- Term: Nidovirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000094025

- Term: Post-Infectious Disorders

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000000857

- Term: Olfaction Disorders

- ID: D000012678

- Term: Sensation Disorders

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000013651

- Term: Taste Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M3013

- Name: Post-Acute COVID-19 Syndrome

- Relevance: HIGH

- As Found: Long COVID

- ID: M2561

- Name: COVID-19

- Relevance: HIGH

- As Found: COVID-19

- ID: M2570

- Name: Anosmia

- Relevance: HIGH

- As Found: Anosmia

- ID: M3720

- Name: Ageusia

- Relevance: HIGH

- As Found: Ageusia

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M13914

- Name: Pneumonia, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20490

- Name: Coronavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6555

- Name: Coronaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M23685

- Name: Nidovirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3014

- Name: Post-Infectious Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M4183

- Name: Olfaction Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M15490

- Name: Sensation Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M16423

- Name: Taste Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000086382

- Term: COVID-19

- ID: D000094024

- Term: Post-Acute COVID-19 Syndrome

- ID: D000086582

- Term: Anosmia

- ID: D000000370

- Term: Ageusia

### Misc Info Module

- Version Holder: 2024-05-31
