Olfaction Disorders in Patients Included in The Trauma Brain Injury (TBI) Database at Trondheim University Hospital: Prevalence and Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- number of patients who have improved olfaction perception (by at least 5 points on the Threshold-Discrimination-Identification (TDI) score
研究概览
简要总结
The aim of the study is to see whether patients with chronic smell impairment after brain injury benefit from a treatment that consists of corticosteroids, and then olfactory training in 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Registered in the TBI Database
- •18-65 years of age per 01.
- •Olfaction score by Sniffin Sticks Threshold-Discrimination-Identification (TDI) < 30 confirming dysosmia
排除标准
- •Unable to express senses.
- •Unable to follow treatment and protocol
- •pregnancy
- •tendency to infections
- •hypertonia
- •dyspepsia
- •interfering medication (hormonal treatment, NSAIDS, antidiabetics, barbiturates, fenitoin, carbamazepin, rifampicin, cyclophosphamides)
研究组 & 干预措施
Olfactory disorder after brain trauma
Recruited from 250 patients with moderate to severe traumatic brain injury in the Hodeskadeprosjektet (TBI) cohort. Treatment with (first) corticosteroids and (second) olfactory stimulation.
干预措施: corticosteroids (Drug)
Olfactory disorder after brain trauma
Recruited from 250 patients with moderate to severe traumatic brain injury in the Hodeskadeprosjektet (TBI) cohort. Treatment with (first) corticosteroids and (second) olfactory stimulation.
干预措施: olfactory stimulation (Behavioral)
结局指标
主要结局
number of patients who have improved olfaction perception (by at least 5 points on the Threshold-Discrimination-Identification (TDI) score
时间窗: 1 year
TDI score measured by Sniffin Sticks
次要结局
未报告次要终点