Ignite Creation Date:
2024-05-06 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05177445
Status:
UNKNOWN
Last Update Posted:
2022-01-04
First Post:
2021-10-15
Brief Title:
Efficacy and Safety of Phototherapy in the Treatment of Loss of Smell Post Acute Infection of Coronavirus 19
Sponsor:
Respiralab
Organization:
Respiralab
Study Overview
Official Title:
Efficacy and Safety of Phototherapy in the Treatment of Loss of Smell Post Acute Infection of Coronavirus 19
Status:
UNKNOWN
Status Verified Date:
2021-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Spearmans 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 005 Analyses will be performed using Statistical Package for the Social Sciences V 220 software
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 Spearmans 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 005 Analyses will be performed using Statistical Package for the Social Sciences V 220 software
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None