Study of the Evolution of Olfactory Disorders in Patients With Persistent Loss of Smell Following COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Measurement of olfactory responses by PEO recording and by calculating the TDI score of the Sniffin'stick tests.
研究概览
简要总结
The COVID-19 pandemic is a novel medical challenge, particularly because of the systemic nature of this disease. Indeed, COVID-19 affects several organs and systems at once. The brain is affected in several ways: direct infection of nerve cells by SARS-CoV-2, inflammation of the central nervous system, severe systemic inflammation damaging nerve cells, global cerebral ischaemia related to respiratory failure, thromboembolic events related to increased intravascular coagulation and severe psychological stress. As a result, COVID-19 sometimes manifests as neurological and neuropsychiatric symptoms such as dizziness, sleep disturbances, cognitive deficits, delirium, or severe depression.
Sudden loss of smell is a common symptom associated with COVID-19 and SARS-CoV-2 infection of neurons in the olfactory system has been reported in both hamsters and humans. The vast majority of COVID-19 patients recover their olfactory function within a few weeks. However, a significant minority of infected individuals (1 in 5 cases) still suffers from olfactory disorders (anosmia, hyposmia and/or parosmia) several months after the primary infection. These olfactory disorders are frequently associated with depressive behaviour and cognitive complaints. In PET scans, it is even possible to correlate this cognitive dysfunction with hypometabolism of certain brain regions, including the olfactory gyrus.
This project proposes, during one year, to evaluate and follow the evolution of the olfactory capacities of patients suffering from persistent smell disorder since one year (+/- 4 months) following COVID-19. The issue is to study the link between viral persistence in the olfactory sensory organ, chronic inflammation, and central damage to the olfactory system. The follow-up of the evolution of olfactory and neurocognitive capacities, in an integrative way by means of molecular, physiological and behavioural approaches, will inform us on the specificities of "COVID-long" and on the level of peripheral and/or central damage of the olfactory system.
详细描述
Prospective monocentric descriptive study. Evaluation of COVID-19 patients with persistent loss of smell during 2 visits at 1 year intervals (V1 and V2).
V1 :The following examinations will be carried out specifically for the research.
- Clinical examination;
- Blood sampling;
- Recording of olfactory evoked potentials;
- Neurological examination and neuropsychological assessment;
V2 :
All examinations performed at V1 will be repeated at V2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults < 55 years
- •History of symptomatic COVID over 1 year +/- 4 months with a positive PCR diagnosis of SARS-CoV-2
- •Olfactory complaint
- •Able to understand simple questionnaires in French.
- •Subject covered by French Social Security (except for Aide Médicale d'Etat).
排除标准
- •Contraindication to nasal swabbing (for morphological reasons, haemostasis disorders, taking aspirin in the 15 days prior to swabbing or anticoagulants, contraindications to the use of a local anaesthetic such as a history of allergy to local anaesthetics or any other reasons judged by the clinical investigator)
- •To have been placed in the intensive care unit following COVID-
- •Known previous nasal-sinus pathology.
- •History of psychiatric pathology according to DSM IV criteria, ischaemic, neoplastic, inflammatory, infectious or neurodegenerative (meningitis, encephalopathy, encephalitis, stroke, neurodegenerative disease) known or suspected.
- •History of loss of sense of smell prior to COVID infection.
- •Patient affiliated to the Aide Médicale d'Etat.
- •Person deprived of liberty by judicial or administrative decision, or subject to legal protection.
研究组 & 干预措施
Study population
Adult subjects up to 55 years of age with persistent olfaction disorder after a symptomatic episode of COVID-19.
干预措施: Blood collection (Other)
Study population
Adult subjects up to 55 years of age with persistent olfaction disorder after a symptomatic episode of COVID-19.
干预措施: Olfactory evoked potentials (Other)
Study population
Adult subjects up to 55 years of age with persistent olfaction disorder after a symptomatic episode of COVID-19.
干预措施: Clinical examination (Other)
Study population
Adult subjects up to 55 years of age with persistent olfaction disorder after a symptomatic episode of COVID-19.
干预措施: Brushing of olfactory slits (Other)
Study population
Adult subjects up to 55 years of age with persistent olfaction disorder after a symptomatic episode of COVID-19.
干预措施: Neurological examination and neuropsychological assessment (Other)
Study population
Adult subjects up to 55 years of age with persistent olfaction disorder after a symptomatic episode of COVID-19.
干预措施: Nasal endoscopy (Other)
Study population
Adult subjects up to 55 years of age with persistent olfaction disorder after a symptomatic episode of COVID-19.
干预措施: Assessment of olfactory and taste functions (Other)
结局指标
主要结局
Measurement of olfactory responses by PEO recording and by calculating the TDI score of the Sniffin'stick tests.
时间窗: 24 months
To characterise the evolution of the olfactory capacities of patients suffering from persistent odour disorders following SARS-CoV-2 infection over the course of a year.
次要结局
- To characterise any damage to the olfactory nerve(24 months)
- Measurement of patients' cognitive performance by neuropsychological assessment (standardised tests).(24 months)
- Measurement of olfactory perception threshold, olfactory discrimination capacity and odour identification.(24 months)
- To identify the presence of inflammatory markers in patients.(24 months)
- To characterise the persistence of SARS-CoV-2 in the olfactory epithelium.(24 months)
- Detection and measurement of markers of neurological disorders in the blood.(24 months)