At-Home Olfactory Training With Essential-Oil Based Scents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in ability to detect odorants - Sniffin' Sticks
研究概览
简要总结
The purpose of this study is to determine the impact of a twice daily at-home olfactory training program with a twenty scent, essential oil-based smell test in patients with olfactory dysfunction.
详细描述
This study randomizes participants to receive either a four scent or fourteen scent olfactory retraining protocol. Baseline olfaction will be tested with a currently commercially available smell test as well as an essential oil based smell test. The protocol involves twice daily retraining where the participant inhales the scent and makes a mental note of what they should be smelling. The training period is six months total with a visit at 3 months to re-assess smell function as well as at six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have clinical olfactory dysfunction
排除标准
- •Pregnant women
- •Unable to perform routine follow-up
- •Current participation in another clinical trial during this trial
- •Patients with dementia, Alzheimer's disease, Parkinson's disease, or other neurocognitive disorders
- •Diagnosis of other systemic conditions known to impact the sinonasal cavity such as Wegener's granulomatosis, Churg Strauss, and immunodeficiency
- •Patients who are allergic to any of the smells or components of our olfactory testing
- •Chronic rhinosinusitis, malignant tumors and/or oncologic therapies (radiation/chemotherapy)
- •History of surgery on the nose or paranasal sinuses
- •Patients using medications that may impact olfactory function (i.e. corticosteroids)
结局指标
主要结局
Change in ability to detect odorants - Sniffin' Sticks
时间窗: Change from Baseline to Month 6
Sniffin Sticks are a battery of 12 scents within a tube. The subject smells each scent and then chooses from 4 multiple choice options which is the scent they smelled. Increased number of correct responses indicates better sense of smell. 12/12 is the maximum score. 0/12 is the minimum score.
Change in ability to detect odorants - AROMA
时间窗: Change from Baseline to Month 6
AROMA is a essential oil based test. The subject is asked to respond if they detect a smell. If yes, they proceed to a 4 multiple choice items and select the item the smell. If no, they proceed to the next item. Higher number correct indicates better sense of smell. It consists of 13 odorants and 1 blank. Improved sense of smell would also increase the number of correctly identified odorants out of the 14 (including noting the 1 blank).
次要结局
- SF-12 (Short Form Health Survey)(Change from Baseline to Month 6)
- Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS)(Change from Baseline to Month 6)