Clinical Outcomes of Olfactory Training for Treatment of Olfactory Dysfunction After COVID-19
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- To Assess the effectiveness of olfactory training therapy in the treatment of persistent olfactory dysfunctions after COVID-19
研究概览
简要总结
It is a randomized controlled clinical trial study that aims to follow a sample of individuals with persistent olfactory dysfunction post-COVID-19. The aim of this study is assess the clinical outcomes of olfactory training therapy in the treatment of persistent olfactory dysfunctions after COVID-19. The sample will consist of 350 participants, being 300 individuals with persistent olfactory dysfunction post-COVID-19 and 50 healthy individuals. Volunteers' will be separated in two experimental groups (1 and 2 ) and a control group. All participants will be submitted to clinical evaluation that include the Connecticut Chemosensory Clinical Research Test (CCCRT), an olfactory test to diagnose anosmia and hyposmia, and two skull Magnetic Resonance imaging (MRI). Only participants of Experimental group 1 will be submitted to an olfactory training with essences oils. Experimental group 2 will only receive a clinical follow-up after three months and control group will be only submitted to neurological exam, olfactory test, MRI imaging and test their ability to discriminate the essence oils used in olfactory training. As a result, is expected a better understanding of the characteristics of olfactory dysfunction caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) virus infection, as well as the effectiveness and viability of using Olfactory Training as a therapeutic alternative.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants of groups will be evaluated and random inserted in one of the experimental groups. The person responsible for reassessment will be blinded for which group the individual reassessed came from.
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
- 是
入选标准
- •Confirmed diagnosis of COVID-19 by Real Time Polymerase chain-reaction for SARS-CoV-2 or serological tests for SARS-CoV-2 antigens.\
- •Olfactory dysfunction confirmed by Connecticut Chemosensory Clinical Research Test (CCCRC-T).
排除标准
- •Individuals with diagnosed rhinitis
- •Individuals with diagnosed Neurological diseases
- •Individuals submitted to brain surgery
- •Previous historic of hyposmia and/ or anosmia
- •Pregnancy
- •Allergy to any of the substances present in the olfactory test kit
- •Individuals who are undergoing another treatment for olfactory dysfunction
结局指标
主要结局
To Assess the effectiveness of olfactory training therapy in the treatment of persistent olfactory dysfunctions after COVID-19
时间窗: 4 years
The individuals of Experimental group 1 will be submitted to a olfactory training with essence oils, the participants will be reassessed with Olfactory test CCCRT monthly and this results will be compared with the reassessment results of the Experimental group 2 (no intervention group). The results of CCCRT of these two groups will be compared with Control group. The CCCRT olfactory test consists of n-butanol smell threshold test and smell identification test. Olfactory function score will be assessed (0: worst score; 7: best score).
次要结局
- To Measure by means of a standardized olfactory test the olfactory dysfunctions present in post-COVID-19 patients(4 years)
- Propose an olfactory training protocol appropriate to the demands of patients with post-COVID-19 olfactory dysfunction and in accordance with the reality of Brazilian public health services(4 years)
- To Investigate by means of skull nuclear magnetic resonance (MRI) exams for possible neural correlates of olfactory dysfunctions present in post-COVID-19 patients(4 years)
研究者
ALNA CAROLINA MENDES PARANHOS
Professor
Universidade do Estado do Pará