Determinants of Olfactory Dysfunction in Chronic Rhinosinusitis
试验速览
- 阶段
- 不适用
- 入组人数
- 418
- 主要终点
- Sniffin' Stick olfactory testing
研究概览
简要总结
Olfactory dysfunction is a cardinal symptom of chronic rhinosinusitis, a disease which affects 12.5% of the adult population across all racial and ethnic groups. Previous research has documented olfactory deficit in 68% of patients with chronic rhinosinusitis and 20% with complete anosmia, suggesting that olfactory dysfunction affects over 25 million individuals in the United States with chronic rhinosinusitis. This proposed investigation will be used to predict olfactory outcomes following treatments for chronic rhinosinusitis and gain insights into mechanisms of olfactory dysfunction in this population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ( > 18 years of age)
- •A diagnosis of medical recalcitrant CRS as defined by 2015 Adult Sinusitis Guidelines outlined by the American Academy of Otolaryngology
- •Provide written informed consent and authorization.
- •Study participants must be able to complete consent, all study evaluations, olfactory testing, and study-related health questionnaires written in the English language.
- •Patients must self-select subsequent treatment option (endoscopic sinus surgery or continued medical therapy) to be dictated by the disease process and judgment and preferences of each individual, following counseling for each treatment option.
- •Present to the enrolling site with indication for a CT scan or a CT scan completed, off-site, from another provider
- •Complete appropriate standardized medical treatment by the Interim Assessment, 6-week follow-up period including, but not limited to, at least one course of either topical corticosteroids (>21-days) or a 5-day course of oral corticosteroid therapy, and at least one course (>14-days) of culture-directed or broad spectrum antibiotic therapy.
排除标准
- •Children (< 18 years of age)
- •Any patient unable and/or unwilling to complete questionnaires or clinical testing or cooperate with all study protocols.
- •Non-English speaking / English translation services required
- •Unwilling or unable to provide informed, written consent.
- •Contra-indications for any type of continued medical therapy required for treatment of symptoms related to CRS
- •Patients who have not undergone previous prescribed medical therapy as described in Inclusion Criteria.
- •Individuals of any vulnerable population including: children, pregnant women, neonates, decisionally impaired adults, or prisoners.
结局指标
主要结局
Sniffin' Stick olfactory testing
时间窗: 6 months
Improvement in olfactory function
次要结局
- Questionnaire for Olfactory Dysfunction, QOD-NS(6 months)
- 22-Item Sinonasal Outcome Test(6 months)
研究者
Dr. Timothy L. Smith
Professor, Chief of Rhinology
Oregon Health and Science University