NCT04178616终止不适用
Assessment of the Prevalence of Olfactory Disorders in Systemic Scleroderma
University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2019年12月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Percentage of patient with hyposmia defined by a ETOC (European Test of Olfactory Capabilities) score strictly inferior to 27 points
研究概览
简要总结
Prospective monocentric study of patients with systemic sclerosis disease.
The primary outcome is to define the prevalence of olfactory disorders (hyposmia and anosmia) in systemic sclerosis disease.
The secondary outcomes are:
- To assess the correlation of olfaction disorders with clinical and biological and factors related to systemic sclerosis patients.
- To estimate the frequency of sinonasal disorders in patients with systemic sclerosis disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Men and/or women
- •With systemic sclerosis disease
- •Patient willing to comply with all procedures of the study and its duration
- •Social insured patients
排除标准
- •Patient with medical history of chronic rhinosinusitis (CRS), previously known for olfactory disorders secondary to another etiology (skull base trauma, viral rhinosinusitis)
- •Past history of sinonasal surgery
- •Patient unable to receive informed information
- •Refusal to sign the consent form
- •Unwillingness or inability to follow the study procedures, in the opinion of the investigator
- •Person deprived of the liberty
- •Non-coverage by the social security insurance
- •Person benefiting from a system of legal protection (guardianship...)
结局指标
主要结局
Percentage of patient with hyposmia defined by a ETOC (European Test of Olfactory Capabilities) score strictly inferior to 27 points
时间窗: once time, Baseline
The European Test of Olfactory Capabilities is an olfactory test based on standardized odorants.A composite score evaluates the ability of the patients to define odors localisation and odors identification.The maximum global score is 32 points, the minimum is 0 point. The localisation ability score is rated from 0 to 16 points; The identification score is rated from 0 to 16 points. An hyposmia is defined by a global score strictly inferior to 27 points.
次要结局
- Percentage of patient with anosmia defined by a ETOC (European Test of Olfactory Capabilities) score strictly inferior to10 points(once time, Baseline)
- Correlation between global olfactory score measured with ETOC score and skin involvement severity measured with Rodnan score.(once time, Baseline)
- Correlation between global olfactory score measured with ETOC score and the rhinologic quality of life score measured with the sinonasal outcome test 22)(once time, Baseline)
- Percentage of patients with an unilateral Lund Kennedy score of more than 3 points.(once time, Baseline)
- Measurement of systemic sclerosis disease activity with Medsger Score(once time, Baseline)
- Correlation between global olfactory score measured with ETOC score and systemic sclerosis disease activity measured with Medsger Score(once time, Baseline)
- Correlation between global olfactory score measured with ETOC score and systemic sclerosis disease activity measured with Health Assessment Questionnaire (HAQ) score(once time, Baseline)
- Correlation between global olfactory score measured with ETOC and Hospital anxiety and Depression (HAD) scale.(once time, Baseline)
研究者
研究点 (2)
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