NCT05562050进行中（未招募）不适用
Characteristics of the Anosmic Olfactory Mucosa
Nicolai Nielsen1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2023年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Histological evaluation
研究概览
简要总结
The present study aims to describe the structural tissue and cell characteristics of the olfactory mucosa in patients with persistent anosmia (≥2 years) due to COVID-19 or head-trauma, in comparison to healthy individuals with intact olfactory function. In order to avoid possible age-related degenerative changes in the neuro-epithelium, both patients and controls are between 25 and 35 years of age.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Legally competent to vouch for their own study participation.
- •Informed and written consent for participation in this study.
- •Study group 1 (Post-COVID anosmia)
- •Diagnosed with persistent anosmia for approximately two years concurring with positive SARS-CoV-2 PCR-test between 2019 and
- •Sniffin'sticks test with a threshold-discrimination-identification-score(TDI)≤16
- •Between 25 and 35 years of age.
- •Study group 2 (Post-trauma anosmia)
- •Diagnosed with persistent anosmia for approximately two years concurring with head trauma.
- •Sniffin'sticks test with a threshold-discrimination-identification-score(TDI)≤16
- •Between 25 and 35 years of age.
- •Study group 3 (Controls):
- •Between 25 and 35 years of age.
- •Undergoing reposition of a nasal fracture in general anaesthesia
排除标准
- •<25 years of age.
- •>35 years of age.
- •Chronic rhinosinusitis with/without polyps.
- •Nasal cancer.
- •Presence of viral or bacterial rhinosinusitis.
- •Uncontrolled allergic rhinosinusitis.
- •Coagulation deficiencies, e.g. haemophilia.
- •Use of anticoagulants.
- •Not able to undergo general anaesthesia.
- •Pregnancy.
- •Any use of nasal detumescence drugs ≤2 weeks before biopsy.
- •Any use of nasal steroids ≤3 months before biopsy.
- •Use of nasal inhaled recreational drugs ≤3 month before biopsy.
- •Participants not able to communicate in Danish or English.
- •Major Depression Inventory (MDI) score ≥27 [49, 50]
- •Mini Mental State Examination (MMSE) score ≤ 26 [51]
- •Study group 1 (Post-COVID anosmia)
- •Anosmia for less than two years or more than two and a half years.
- •No positive SARS-CoV-2 PCR-test concurring with olfactory dysfunction.
- •History of olfactory dysfunction before COVID-19 infection.
- •Study group 2 (Post-trauma anosmia)
- •Anosmia for less than two years or more than approximately two-three years.
- •Anosmia without concurring with head trauma
- •History of prior olfactory dysfunction before head trauma.
- •Study group 3 (Controls)
- •Known olfactory dysfunction.
结局指标
主要结局
Histological evaluation
时间窗: 2023-2024
density
Immunohistochemical evaluation
时间窗: 2023-2024
density
次要结局
未报告次要终点
研究者
Nicolai Nielsen
Medical doctor
Regional Hospital West Jutland
研究点 (1)
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