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

Not Applicable

• Conditions: Smell Disorders

• Registration Number: NCT05177445
• Lead Sponsor: Respiralab

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.

Study Timeline

• Study First Submitted: 2021-10-15
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-14
• Last Update Submitted: 2021-12-14
• Study First Posted: 2022-01-04
• Last Update Posted: 2022-01-04
• Study Start: 2022-04
• Primary Completion: 2022-12
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Change of Loss of Smell in Visual Analog Scale (VAS)	It will be assessed through the study completion, an average of 15 weeks.	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	It will be assessed through the study completion, an average of 15 weeks.	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)	It will be assessed through the study completion, an average of 15 weeks.	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

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

Respiralab Research Group; 🇪🇨 Guayaquil, Guayas, Ecuador