Efficacy and safety of high dose glucocorticosteroid treatment for idiopathic sudden sensorineural hearing loss (HODOKORT) - HODOKORT

Martin-Luther-Universität Halle-Wittenberg0 个研究点目标入组 312 人开始时间: 2016年3月8日最近更新: 2020年4月14日

适应症

试验速览

暂无简介。

•-female and male adults (18-80 years)
•-unilateral sensorineural hearing loss
•-sudden onset of hearing loss (occurring within 24 hours)
•-unknown etiology (no other ear or CNS disease)
•-change in hearing threshold due to ISSHL of 30 dB or higher (as compared to a pre-event audiogram, the audiogram of the unaffected ear, or the ISO) for the 3 most affected contiguous frequencies in the affected ear but not less then 50 dB absolute threshold as average of the 3 most affected contiguous frequencies between 0,25 und 8 kHz < 50 dB HL
•-enrolment and treatment within 7 days from onset
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 156
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 156

•-recurrent ISSHL at the affected side (< 12 months)
•-known other otologic cause of ISSHL (e.g.: middle ear disease; vestibular schwannoma; known fluctuating hearing loss; Meniere’s disease)
•-absolute hearing threshold as average of the 3 most affected contiguous frequencies between 0,25 und 8 kHz < 50 dB HL
•-certain systemic diseases (treatment for or chronically active infection such as HIV, hepatitis C or B, tuberculosis, hard to balance diabetes mellitus, ongoing immunosuppressive treatment for rheumatic or chronic inflammatory disease, unstable atherosclerotic disease, heart failure >NYHA II, suicidality, severe osteoporosis, active peptic ulcer, uncontrolled (syst. >180 mmHg or diast. >100 mmHg) arterial hypertension)
•-treated mental disorders or after surgical interventions in the last 6 weeks: inclusion only after critical evaluation by the investigator
•-pre-treatment of ISSHL with glucocorticosteroids or hyperbaric oxygen
•-conductive deafness (air-bone gap 4PTA0,5-4kHz >10 dB)
•-pregnancy or lactation

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