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临床试验/NCT05999461
NCT05999461已完成不适用

Association of Auditory Dysfunction With Retinal Ischemia in Behcet Disease

Assiut University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
correlation of hearing abnormalities with retinal ischemia

研究概览

简要总结

Auditory dysfunction is commonly detected in Behçet's disease (BD). Also, vestibular abnormalities as well as cochlear function affection have been found. The inflammatory process in BD may be the cause of audiometry abnormalities in those patients. The aim of this study is to assess hearing dysfunction in Behçet patients and its relation to retinal ischemia and disease activity using conventional pure-tone audiometry (cPTA), tympanogram and acoustic reflex

详细描述

pure tone audiometry is a behavioral test used to measure hearing sensitivity. This measure involves the peripheral and central auditory systems. Pure-tone thresholds (PTTs) indicate the softest sound audible to an individual at least 50% of the time. Hearing sensitivity is plotted on an audiogram, which displays intensity as a function of frequency.

Speech audiometry employs speech signals to assess if the patient has problems hearing speech or speech in noise. Speech audiometry can be used to examine the processing ability and if it is affected by disorders of the middle ear, cochlea, auditory nerve, brainstem pathway, or auditory centers of the cortex.

Tympanogram is a test of middle ear functioning. This objective test also allows to view the functioning of the Eustachian Tube, the upper auditory pathways and the reflex contraction from the middle ear muscles. Impedance testing is crucial in distinguishing a conductive loss from a sensorineural hearing loss.

Optical coherence tomography angiography (OCT-A) for imaging the microvasculature of the retina and the choroid.

Behcet disease current activity form for assessment of disease activity range from 0 to 12 . 12 represents the highest disease activity. It depends on the symptoms present over the last 4 weeks.

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
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All patients fulfill the International Criteria of behcet disease

排除标准

  • age more than 50
  • ear infection,
  • ear trauma, acoustic trauma, or usage of ototoxic drugs.
  • Also, associated systemic diseases that can affect the hearing as infectious diseases (e.g., mumps, CMV), granulomatous diseases (e.g., sarcoidosis, Wegner's granulomatosis), other autoimmune diseases (e.g., Rheumatoid arthritis, Cogan's syndrome, polyarteritis nodosa, relapsing polychondritis), and diseases of the bone (e.g., Paget's disease).

结局指标

主要结局

correlation of hearing abnormalities with retinal ischemia

时间窗: 3 months

oct angiography

Detection of hearing abnormalities in behcet disease

时间窗: 3 MONTHS

pure tone audiometry, tympanogram and acoustic reflex

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maha Sayed Ibrahim Abdelrahman

Principal investigator

Assiut University

研究点 (1)

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