Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Manuel I Cherrez Ojeda, MD. MsC. | RESPIRALAB RESEARCH GROUP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Respiralab Research Group | Guayaquil | Guayas | 090512 | Ecuador |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19626333 | Background | 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. | |
| 12231198 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000857 | Olfaction Disorders |
| D000086582 | Anosmia |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D000305 | Adrenal Cortex Hormones |
| D000094562 | Olfactory Training |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
Interventional study, single blinded, convenience sampling.
Not provided
Not provided
Patients will receive information about both treatments, but won't have knowledge about which treatment is applied.
|
|
| 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. |
|
|
| It will be assessed through the study completion, an average of 15 weeks. |
| 17903622 | 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. |
| 33423106 | 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. |
| 20021238 | 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. |
| 15191052 | 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. |
| 34291813 | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |