Efficacy and Safety of Phototherapy in the Treatment of Loss of Smell Post Acute Infection of Coronavirus 19

NCT05177445 | Unknown

• 1 other identifier: HCK-RNLTA-19-0007
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess whether the use of a therapy combining olfactory training, corticoids, and phototherapy improves the PROMS compared to the use of olfactory training and corticosteroids only. To accomplish this goal the study will consist of 40 participants. The participants must present olfactory dysfunction for at least 4 weeks after a coronavirus-19 infection. Furthermore, to be eligible each participant will need a polymerase chain reaction test with positive results for coronavirus-19.

Conditions

Smell Disorders

Keywords

Anosmia; Hyposmia; Coronavirus; Smell Disorders; Phototherapy

Outcome Measures

Primary Outcomes (3)

• Change of Loss of Smell in Visual Analog Scale (VAS)

  The Visual Analog Scale (VAS) scale is able to determine the grade of loss of smell. From 1 to 10, being 1 the minimum and 10 the maximum grade of loss of smell.

  It will be assessed through the study completion, an average of 15 weeks.

• Changes in the Threshold Discrimination Identification (TDI) score

  The Threshold Discrimination Identification score (TDI) is used when the patient undergoes olfactory training, it is comprised by 3 tests: the threshold, discrimination, and identification. Each result is interpreted according to 4 age groups. The test is accomplished by having the patient sniff at a felt pen which has been impregnated with 4ml of odorant fluid dissolved in propylene glycol. TDI scores defined functional anosmia as a TDI score \<16,5, normosmia as a TDI score \>30.5 and hyposmia as a score between these two values.

  It will be assessed through the study completion, an average of 15 weeks.

• Changes of olfactory dysfunction in the Self-reported mini olfactory questionnaire (Self-MOQ)

  The Self-reported mini olfactory questionnaire (Self-MOQ) is a simple, reliable and valid questionnaire to screen olfactory dysfunction in clinical practice. For the sample in the current study, the optimal scores will be 3.5, 4.5, and 3.5 for distinguishing normosmic from hyposmic/ anosmic patients, anosmic patients, and hyposmic patients, respectively.

  It will be assessed through the study completion, an average of 15 weeks.

Secondary Outcomes (1)

• Changes in Anxiety and depression in the Hospital Anxiety and Depression Scale(HADS)

  It will be assessed through the study completion, an average of 15 weeks.

Study Arms (2)

Intervention group with phototherapy

EXPERIMENTAL

Patients that present loss of smell 4 weeks after their coronavirus-19 infection and that have had a real-time polymerase chain reaction (reverse transcriptase polymerase chain reaction ) positive for coronavirus-19 will receive the phototherapy intervention. It consists of the introduction of the nasal probe of the phototherapy device in the nasal cavity of the patient. A mixture of ultraviolet light A, ultraviolet light B and red light will be applied between 2 and 3 minutes. The patient will receive a maximum of 10 interventions. Furthermore both oral corticosteroids (prednisone 40mg) and olfactory training will be applied, in the intervals of daily for 10 days and daily for the duration of the study respectively.

Combination Product: Phototherapy

Intervention group (corticosteroids + OT) without Phototherapy

ACTIVE COMPARATOR

Patients that present loss of smell 4 weeks after their coronavirus-19 infection and that have had a real-time polymerase chain reaction (reverse transcriptase polymerase chain reaction )and both oral corticosteroids (prednisone 40mg) and olfactory training will be applied, in the intervals of daily for 10 days and daily for the duration of the study respectively.

Combination Product: OT+Corticosteroids

Interventions

Phototherapy COMBINATION_PRODUCT

Prior to the beginning of the procedure the patient will be administered a nasal decongestant. Second to this, the patient will be advised to blow his/her nose. This step allows the physician a better view and allows the light exposure to reach the majority of the nasal mucosa(9). To start the intervention the physician will introduce the phototherapy device inside the patient's nasal cavity as the patient sits in an upright condition. As the procedure is ongoing the physician will slightly rotate the device in order to minimize dryness and to irradiate all the nasal cavity. After the intervention the patient will be administered an emollient/moisturizing drug to further hydrate the nasal mucosa(9). The intervention will have a crescent duration, the first one will be only two minutes and the following ones will increase 15 seconds each until a plateau is reached at 3 minutes in the 5th intervention.

Also known as: Corticosteroids, Olfactory training

Intervention group with phototherapy

OT+Corticosteroids COMBINATION_PRODUCT

Patients that present loss of smell 4 weeks after their coronavirus-19 infection and that have had a real-time polymerase chain reaction (reverse transcriptase polymerase chain reaction )and both oral corticosteroids (prednisone 40mg) and olfactory training will be applied, in the intervals of daily for 10 days and daily for the duration of the study respectively.

Also known as: Corticosteroid, Olfactory training

Intervention group (corticosteroids + OT) without Phototherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive coronavirus polymerase chain reaction patients who experience loss of smell for more than 4 weeks after symptoms begin will be included in the study but at time of the trial with a negative result from a polymerase chain reaction.
• Patients older than18 years.

You may not qualify if:

• Patients younger than 18 years.
• Pregnancy.
• Patients who do not have a positive real-time polymerase chain reaction for Coronavirus
• Patients who have contraindications for corticosteroid therapy such as:
• Pregnant patients
• Immunosuppressed
• Patients with peptic ulcer
• Diabetics
• Patients with glaucoma

Sponsors & Collaborators

• Respiralab: lead

Study Sites (1)

Respiralab Research Group

Guayaquil, Guayas, 090512, Ecuador

Location

Related Publications (7)

• Cingi C, Yaz A, Cakli H, Ozudogru E, Kecik C, Bal C. The effects of phototherapy on quality of life in allergic rhinitis cases. Eur Arch Otorhinolaryngol. 2009 Dec;266(12):1903-8. doi: 10.1007/s00405-009-1048-y. Epub 2009 Jul 22.

  PMID: 19626333 BACKGROUND

• Beissert S, Schwarz T. Role of immunomodulation in diseases responsive to phototherapy. Methods. 2002 Sep;28(1):138-44. doi: 10.1016/s1046-2023(02)00217-7.

  PMID: 12231198 BACKGROUND

• Matz H. UV light and its interaction with cutaneous receptors. Dermatol Clin. 2007 Oct;25(4):633-41, x. doi: 10.1016/j.det.2007.06.006.

  PMID: 17903622 BACKGROUND

• Le Bon SD, Konopnicki D, Pisarski N, Prunier L, Lechien JR, Horoi M. Efficacy and safety of oral corticosteroids and olfactory training in the management of COVID-19-related loss of smell. Eur Arch Otorhinolaryngol. 2021 Aug;278(8):3113-3117. doi: 10.1007/s00405-020-06520-8. Epub 2021 Jan 9.

  PMID: 33423106 BACKGROUND

• Brehmer D. Endonasal phototherapy with Rhinolight for the treatment of allergic rhinitis. Expert Rev Med Devices. 2010 Jan;7(1):21-6. doi: 10.1586/erd.09.56.

  PMID: 20021238 BACKGROUND

• Novak Z, Berces A, Ronto G, Pallinger E, Dobozy A, Kemeny L. Efficacy of different UV-emitting light sources in the induction of T-cell apoptosis. Photochem Photobiol. 2004 May;79(5):434-9. doi: 10.1562/ra-003r.1.

  PMID: 15191052 BACKGROUND

• O'Byrne L, Webster KE, MacKeith S, Philpott C, Hopkins C, Burton MJ. Interventions for the treatment of persistent post-COVID-19 olfactory dysfunction. Cochrane Database Syst Rev. 2021 Jul 22;7(7):CD013876. doi: 10.1002/14651858.CD013876.pub2.

  PMID: 34291813 BACKGROUND

MeSH Terms

Conditions

Olfaction Disorders; Anosmia; Coronavirus Infections

Interventions

Phototherapy; Adrenal Cortex Hormones; Olfactory Training

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Therapeutics; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Manuel I Cherrez Ojeda, MD. MsC.

  RESPIRALAB RESEARCH GROUP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel I Cherrez Ojeda, MD. MsC.

CONTACT

+593 99 998 1769; ivancherrez@gmail.com

Karla I Robles Velasco, MD.

CONTACT

+593 97 871 5326; karlaroblesvelasco@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will receive information about both treatments, but won't have knowledge about which treatment is applied.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor of Allergy, Immunology and Pulmonology

Model Details: Interventional study, single blinded, convenience sampling.

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: January 4, 2022
• Study Start: April 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: January 4, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)