跳至主要内容
临床试验/CTRI/2023/04/052001
CTRI/2023/04/052001尚未招募不适用

Use of behavioural and physiological hearing tests for early detection of asymptomatic sensorineural hearing loss in systemic lupus erythematosus

MANIPAL ACADEMY OF HIGHER EDUCATION1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年12月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
EFFICIENCY AND CLINICAL USEFULNESS OF AUDIOMETRIC TESTS TO INCORPORATE IT INTO ROUTINE AUDIOLOGIC EXAMINATION

研究概览

简要总结

Otologic manifestations of autoimmune disorders is a rare disease entity. Later the presentation, worse the prognosis in such cases especially since the pathogenesis is unclear. Systemic lupus erythematosus (SLE) is associated with several comorbidities, including hearing and vestibular disorders Ear damage in SLE patients has been occasionally reported. However, the frequency and the mechanisms of ear involvement are not well documented. Andonopoulus et al. in a controlled study showed that 23 out of 40 SLE patients (57.5 per cent) had impaired hearing, which was not associated with the presence of vasculitis, other disease systemic manifestations, or with the presence of anti ds-DNA antibodies. They concluded that these findings are probably attributed to a possible subclinical cochlear hydrops. In a comparative study, Hearing Loss was found in about one fourth of SLE patients. The majority of patients had a SNHL affecting the middle and mainly the high frequencies. Audiometric tests have shown that more than half of SLE patients have chronic sensorineural hearing impairment, often asymptomatic.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ALL PATIENTS DIAGNOSED WITH SLE AND IS ON TREATMENT.

排除标准

  • OTHER AUTOIMMUNE DISEASES 2) OTHER CAUSES OF HEARING LOSS 3) PRIOR HISTORY OF OTOLOGIC PROCEDURES.

结局指标

主要结局

EFFICIENCY AND CLINICAL USEFULNESS OF AUDIOMETRIC TESTS TO INCORPORATE IT INTO ROUTINE AUDIOLOGIC EXAMINATION

时间窗: 1-2 DAYS

PREVALENCE OF SENSORINEURAL HEARING LOSS IN PATIENTS WITH SLE USING ADVANCED AUDIOMETRIC ANALYSIS

时间窗: 1-2 DAYS

次要结局

  • ASSESS SLE DISEASE ACTIVITY USING PHYSICIAN GLOBAL ASSESSMENT (PGA) SCALE AND CORRELATE WITH OCCURENCE OF HEARING LOSS IN DIFFERENT SEVERITY(1 DAY)

研究者

申办方类型
Research institution

研究点 (1)

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