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

Primary Purpose

Smell Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Ecuador
Study Type
Interventional
Intervention
Phototherapy
OT+Corticosteroids
Sponsored by
Respiralab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smell Disorders focused on measuring Anosmia, Hyposmia, Coronavirus, Smell Disorders, Phototherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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:

    1. Pregnant patients
    2. Immunosuppressed
    3. Patients with peptic ulcer
    4. Diabetics
    5. Patients with glaucoma

Sites / Locations

  • Respiralab Research Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group with phototherapy

Intervention group (corticosteroids + OT) without Phototherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Changes in Anxiety and depression in the Hospital Anxiety and Depression Scale(HADS)
The Hospital Anxiety and Depression Scale (HADS) allows for the assessment of both anxiety and depression as it has been seen that both can be present at the same time. This scale focuses on non-physical symptoms so that it can be used to diagnose depression in people with significant physical illness. The questionnaire comprises seven questions for both anxiety and depression, and should take around 2-5min to complete. A score between 8 and 10 is considered as mild, if it is between 11 and 14 it is considered moderate and if it exceeds 15 it is considered severe.

Full Information

First Posted
October 15, 2021
Last Updated
December 14, 2021
Sponsor
Respiralab
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1. Study Identification

Unique Protocol Identification Number
NCT05177445
Brief Title
Efficacy and Safety of Phototherapy in the Treatment of Loss of Smell Post Acute Infection of Coronavirus 19
Official Title
Efficacy and Safety of Phototherapy in the Treatment of Loss of Smell Post Acute Infection of Coronavirus 19
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Respiralab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Standard Operating Procedures: Patients attending consult and calls for follow-up. Plan for missing data: Missing data will be managed with statistical tests. Statistical analysis: Categorical variables, whenever dichotomous or nominal, will be reported as frequencies and percentages. Normality will be assessed by the Kolmogorov Smirnov test. Descriptive statistics will be reported as mean (standard deviation) or median (interquartile range). To analyze the correlation between quantitative variables, the parametric Pearson test or the nonparametric Spearman's test will be used, subjected to their distribution. Differences between Diffusing capacity for carbon monoxide groups will be analyzed for statistical significance by the chi-square test for categorical variables and by a two-sample t-test or Wilcoxon rank-sum test for continuous variables as applicable. Statistical significance will be set at a P-value less than 0.05. Analyses will be performed using Statistical Package for the Social Sciences (V. 22.0) software.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smell Disorders
Keywords
Anosmia, Hyposmia, Coronavirus, Smell Disorders, Phototherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Interventional study, single blinded, convenience sampling.
Masking
Participant
Masking Description
Patients will receive information about both treatments, but won't have knowledge about which treatment is applied.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group with phototherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention group (corticosteroids + OT) without Phototherapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Phototherapy
Other Intervention Name(s)
Corticosteroids, Olfactory training
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
OT+Corticosteroids
Other Intervention Name(s)
Corticosteroid, Olfactory training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Loss of Smell in Visual Analog Scale (VAS)
Description
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.
Time Frame
It will be assessed through the study completion, an average of 15 weeks.
Title
Changes in the Threshold Discrimination Identification (TDI) score
Description
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.
Time Frame
It will be assessed through the study completion, an average of 15 weeks.
Title
Changes of olfactory dysfunction in the Self-reported mini olfactory questionnaire (Self-MOQ)
Description
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.
Time Frame
It will be assessed through the study completion, an average of 15 weeks.
Secondary Outcome Measure Information:
Title
Changes in Anxiety and depression in the Hospital Anxiety and Depression Scale(HADS)
Description
The Hospital Anxiety and Depression Scale (HADS) allows for the assessment of both anxiety and depression as it has been seen that both can be present at the same time. This scale focuses on non-physical symptoms so that it can be used to diagnose depression in people with significant physical illness. The questionnaire comprises seven questions for both anxiety and depression, and should take around 2-5min to complete. A score between 8 and 10 is considered as mild, if it is between 11 and 14 it is considered moderate and if it exceeds 15 it is considered severe.
Time Frame
It will be assessed through the study completion, an average of 15 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel I Cherrez Ojeda, MD. MsC.
Phone
+593 99 998 1769
Email
ivancherrez@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Karla I Robles Velasco, MD.
Phone
+593 97 871 5326
Email
karlaroblesvelasco@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel I Cherrez Ojeda, MD. MsC.
Organizational Affiliation
RESPIRALAB RESEARCH GROUP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Respiralab Research Group
City
Guayaquil
State/Province
Guayas
ZIP/Postal Code
090512
Country
Ecuador
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel I Cherrez Ojeda, MD. MsC.
Phone
+593 99 998 1769
Email
ivancherrez@gmail.com
First Name & Middle Initial & Last Name & Degree
Karla I Robles Velasco, MD.
Phone
+593 99 998 1769
Email
karlaroblesvelasco@gmail.com
First Name & Middle Initial & Last Name & Degree
Manuel I Cherrez Ojeda, MD. MsC.
First Name & Middle Initial & Last Name & Degree
Karla I Robles Velasco, MD.
First Name & Middle Initial & Last Name & Degree
Maria J Farfan Bajaña, Bachelor
First Name & Middle Initial & Last Name & Degree
Matias Panchana Lascano, Bachelor
First Name & Middle Initial & Last Name & Degree
Christian A Rodriguez Holguin, MD.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19626333
Citation
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.
Results Reference
background
PubMed Identifier
12231198
Citation
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.
Results Reference
background
PubMed Identifier
17903622
Citation
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.
Results Reference
background
PubMed Identifier
33423106
Citation
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.
Results Reference
background
PubMed Identifier
20021238
Citation
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.
Results Reference
background
PubMed Identifier
15191052
Citation
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.
Results Reference
background
PubMed Identifier
34291813
Citation
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.
Results Reference
background

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

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