Chronic Cough and Small Fiber Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Proportion of patients with small fiber neuropathy
研究概览
简要总结
Diabetic patients with and without chronic cough will be included in this study. After giving their informed consent, the patients will perform a spirometry, chest X-ray at the inclusion visit. Cough will be assessed using the cough visual analog scale (VAS) and the Leicester Cough Questionnaire (LCQ). Within 60 days, the patient will perform neurophysiological tests. The neurophysiological assessment will be concluded with a skin biopsy to evaluate small fiber neuropathy. The aim of the study is to compare the proportion of small fiber neuropathy between diabetic patients with chronic cough and those without chronic cough.
详细描述
Chronic cough is a very common entity that affects 9.6% people worldwide. Given the high number of patients with refractory cough, the concept of cough hypersensitivity syndrome (CHS) has emerged. In CHS, afferent sensory nerves may exhibit a modification of activation patterns with facilitation of encoding signals in response to irritating stimuli. Similar patterns with neuropathic pain have been described. Small fiber neuropathy has never been assessed in chronic cough. Interestingly, diabetic patients experienced cough more frequently than healthy subject. We hypothesized that small fiber neuropathy may explain chronic cough is more frequent in diabetic patients.
Within 60 days after inclusion, diabetic patients with and without chronic cough will perform neurophysiological tests such as electromyography, thermotest, QSART (Quantitative Sudomotor Axon Reflex Test and Sudoscan), cardio-vascular tests to study the autonomic nervous system. No risks are expecting with these non-invasive tests. A skin biopsy to evaluate small fiber neuropathy will also be performed.After the neurophysiological tests, a consultation will be scheduled at 6 months. A cough VAS and LCQ will be used to assess cough.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •In diabetic patients with chronic cough:
- •Chronic cough defined by cough for more than 8 weeks.
- •Normal chest X-ray
- •history of type 2 diabetes
- •Age of diabetes onset> 40 years
- •Affiliated or beneficiary person of social security
- •Free, informed and written consent
- •In diabetic patients without chronic cough
- •History of type 2 diabetes
- •Age of discovery of diabetes> 40 years
- •Affiliated or beneficiary person of social security
- •Free, informed and written consent
排除标准
- •Presence of physical signs of peripheral neuropathy
- •Active smoking or smoking cessation within the last 12 months
- •Pregnant or lactating woman
- •History of non-type 2 diabetes (type I, secondary diabetes, monogenic ...)
- •Cancer within the last 5 years (except cutaneous squamous cell carcinoma)
- •History of anti-cancer chemotherapy
- •Suspicion of autoimmune pathology
- •Active neurological pathology
- •Electromyography in favor of large fiber neuropathy
- •Chronic pathology that may interfere with the neurophysiological assessment
- •Patient who were given anticoagulation drug therapy, anti-cholinergic drugs, beta-blocker and impossibility to withdraw the treatment before neurophysiological tests
- •In diabetic patients without chronic cough, another non-inclusion criteria is acute or chronic cough
研究组 & 干预措施
Diabetic patients with chronic cough
Diabetic patients with chronic cough defined by cough lasting for more than 8 weeks. Cough assessment, neurological tests and cardiovascular tests and skin biopsy.
干预措施: Cough assessment (Other)
Diabetic patients with chronic cough
Diabetic patients with chronic cough defined by cough lasting for more than 8 weeks. Cough assessment, neurological tests and cardiovascular tests and skin biopsy.
干预措施: Neurological tests and cardiovascular tests (Other)
Diabetic patients with chronic cough
Diabetic patients with chronic cough defined by cough lasting for more than 8 weeks. Cough assessment, neurological tests and cardiovascular tests and skin biopsy.
干预措施: Skin biopsy (Other)
Diabetic patients without chronic cough
Diabetic patients without chronic cough defined by cough lasting for more than 8 weeks. Cough assessment, neurological tests and cardiovascular tests and skin biopsy.
干预措施: Cough assessment (Other)
Diabetic patients without chronic cough
Diabetic patients without chronic cough defined by cough lasting for more than 8 weeks. Cough assessment, neurological tests and cardiovascular tests and skin biopsy.
干预措施: Neurological tests and cardiovascular tests (Other)
Diabetic patients without chronic cough
Diabetic patients without chronic cough defined by cough lasting for more than 8 weeks. Cough assessment, neurological tests and cardiovascular tests and skin biopsy.
干预措施: Skin biopsy (Other)
结局指标
主要结局
Proportion of patients with small fiber neuropathy
时间窗: 6 month after inclusion visit
The primary endpoint is the proportion of patients with small fiber neuropathy between diabetic patients with chronic cough and those without chronic cough (defined by at least 2 abnormal neurophysiological tests).
次要结局
- values of Leicester Cough Questionnaire (LCQ) in diabetic patients(6 month after inclusion visit)
- values of the DN4 questionnaire in diabetic patients(6 month after inclusion visit)
- proportion of patients with abnormal results of laser evoked potentials(6 month after inclusion visit)
- proportion of patients with pathological results of the sudori-motor response(6 month after inclusion visit)
- proportion of patients with abnormal results of the thermotest(6 month after inclusion visit)
- proportion of patients with abnormal findings of cutaneous biopsy(6 month after inclusion visit)
- the proportion of patients with abnormal results of cardiovascular tests(6 month after inclusion visit)