Olfactory Disorder Clinical Trial
Official title:
Intranasal Retinoic Acid Treatment for Patients With Olfactory Loss: A Randomized Controlled Trial
About One to 2 percent of the North American population below the age of 65 years experience
olfactory loss to a significant degree. It can result from advanced age,
Post-infestious/inflammatory disorders, Obstructive disorders (e.g. nasal polyposis, tumors),
posttraumatic (head trauma) and neurodegenerative disorders. Only a few studies have shown
benefits of specific therapy for olfactory loss.
Vitamin has shown promise from both animal and human studies. However, none has studied the
benefits of topical application of vitamin A. This study will be the first to examine this
effect.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 25, 2022 |
Est. primary completion date | December 25, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 90 Years |
Eligibility |
Inclusion Criteria: Patients 19 years and above diagnosed with loss of olfactory function, (with or without history of sinonasal surgery) currently receiving sinonasal-related care at the St Paul's Sinus Centre. Exclusion Criteria: - Patients with Primary anosmia. - Patients with baseline olfactory test scores >30 using Sniffin sticks test. - Patients with sinonasal tumors - Patients with polyps or significant inflammation blocking access of medication to the olfactory cleft. - Patients allergic to topical Vitamin A - Cystic fibrosis or syndromic patients - Patients with autoimmune diseases that have sinus manifestations or affect sinus function - Patients with previous history of hypervitaminosis A - Patients with Neurological Disease (e.g. stroke history, Parkinson's disease) - Patients who are pregnant |
Country | Name | City | State |
---|---|---|---|
Canada | St Paul Hospital | Vancouver | British Columbia |
Canada | St Paul Sinus Centre | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
St. Paul's Hospital, Canada |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Olfactory Tests. | These tests will be performed by same blinded assessor using the "Sniffin sticks" kit described above. The test is divided into three subtests including tests for olfactory thresholds (using phenyl ethyl alcohol), odor discrimination, and odor identification (TDI). The sum of the three scores reliably indicates the degree of olfactory function. | For each subject this test will take 30 minutes | |
Secondary | Sinonasal Outcomes Test - 22 (SNOT-22) | The SNOT-22 is a sinus-specific questionnaire that evaluates subjective symptoms for patients suffering from chronic rhinosinusitis. SNOT-22 is scored out of 110 (22 questions, up to 5-points each) has demonstrated internal consistency, reliability, discriminate and concurrent validity and responsiveness to change. Responses will be summated and considered as a continuous, numerical variable. Mean, median, standard deviation and inter-quartile range will be reported. | For each subject this test will take between 5-10 minutes. | |
Secondary | Sinus Mucosal Inflammation - Philpott-Javer (PJ) and Modified Lund-Kennedy (MLK) Endoscopic Staging System (ESS) | Sinonasal mucosal inflammation is an objective measure assessed endoscopically and graded on both the PJ and MLK ESS for CRS. This is a standard of care procedure at all clinic visits. Similar to the MLK ESS, the PJ ESS scores the sinus cavities as a collective based on endoscopic findings and the presence or absence of allergic mucin. Images and/or videos of all sinuses are captured at each visit and archived on the hospital network as a standard of care. | For each subject this test will take about 5 minutes. | |
Secondary | Questionnaire of Olfactory Disorders | The consists of 25 statements that were divided into three general domains: 17 negative statements (QOD-NS), two positive statements (QOD-PS), and six socially desired statements (QOD-SD). Negative statements give information about the degree patients suffer from olfactory impairment, whereas positive statements indicate how well patients cope with their olfactory deficit. Socially desired statements indicate the extent to which an individual's answers were credible, or whether the person was trying to create a certain impression by providing socially desirable responses. In addition there are also problem questions and questions regarding sense of smell on a visual analogue scale. | For each subject this test will take about 10 minutes. |
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