Persistent Olfactory Loss After COVID-19 : Olfactive Disorder, Psychiatric and/or Cognitive Assessments With and Without a Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Sniffin Stick Tests (score TDI)
研究概览
简要总结
Covid 19 cause an olfactory loss in more than 80% of cases. This loss most often regresses but leaves 20% of patients with an olfactory complaint, particularly with regard to the quality of daily life. The neuro-cognitive implications involved with COVID19 and the consequences of persistent olfactory loss remain unknown. The effectiveness of therapeutic management, in particular olfactory re-education, has not yet been clarified. Objectives are the assessment of patients olfactory disorders, psychiatrics and neurocognitives specificities after a COVID, before and after treatment or specific cares.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults patient,
- •anosmia during a COVID19 acute infection (PCR+) and persistant olfactive disoders at least 6 weeks after symptoms disappeared.
排除标准
- •preexisting smell loss.
结局指标
主要结局
Sniffin Stick Tests (score TDI)
时间窗: 12 months : Evalation at the beginning and the end.
The subjective olfactory losses and recoveries are most often evaluated using the "Sniffin 'Sticks Test®", the current gold standard of objective olfactory tests allowing in a single examination to group together: the definition of an olfactory threshold, olfactory discrimination and olfactory identification in the form of an overall TDI score. Olfactory function using psychophysical tests before and after treatment or specific cares : Sniffin Stick Tests (score TDI). Results can classified patients in Anosmic (TDI\<16,25), Hyposmic (16,25\<TDI\<30,75) and Normosmic (TDI\>30,75). Higher score = better results. Minimal clinically important difference = 5,5.
次要结局
- Situational anxiety and anxiety trait inventory (STAI-Y)(12 months : Evaluation at the beginning and the end.)
- PTSD checklist for DSM-5 (PCL-5)(12 months : Evaluation at the beginning and the end.)
- Hamilton Depression Rating Scale (HDRS)(12 months : Evaluation at the beginning and the end.)
- GROBER BUSCHKE(12 months : Evaluation at the beginning and the end.)
- TODA2 Olfactive Identification(12 months : Evaluation at the beginning and the end.)
- Snaith-HAmilton Pleasure Scale (SHAPS)(12 months : Evaluation at the beginning and the end.)
- Inventory/Apathy Scale(12 months : Evaluation at the beginning and the end.)
- GREMOTS(12 months : Evaluation at the beginning and the end.)
- PPT(12 months : Evaluation at the beginning and the end.)
- TAP (Test of Attentional Performance)(12 months : Evaluation at the beginning and the end.)
- Olfactory Quality of life assessment - Short Version of questionnaire of olfactory disorders(12 months : Evaluation at the beginning and the end.)
- General quality of life assessment (SF-36)(12 months : Evaluation at the beginning and the end.)
- The French quality of life and diet scale (QV-AF)(12 months : Evaluation at the beginning and the end.)