Efficacy and safety of high dose glucocorticosteroid treatment foridiopathic sudden sensorineural hearing loss
- Conditions
- H91Other hearing loss
- Registration Number
- DRKS00010738
- Lead Sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 325
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 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
-enrolment and treatment within 7 days from onset
-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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Average change in hearing thresholds (pure-tone average of the 3 most affected contiguous frequencies)
- Secondary Outcome Measures
Name Time Method -average change in pure tone hearing level (3PTA0,5-2kHz [Fletcher- Typ] und 4PTA0,5-4kHz) 30 days after enrolment<br>-percentage of patients with complete, partial or no improvement of hearing<br>-average change in percentage of ear-specific masked monosyllabic words understood correctly at 65 and 80 dB SPL<br>-patient self evaluation, quality of life and communication competence (patient questionnaires SF-12, HHIE)<br>-percentage of patients needing a hearing aid/ cochlear implant<br>-percentage of patients with new or worsened arterial hypertension at day 5 (office blood pressure >140 mmHg syst. or >90 mmHg diast. or both)<br>-percentage of patients with altered glucose tolerance at day 5 (to be detected by HOMA-IR)<br>-need for rescue therapy<br>-occurrence and extent of tinnitus one and six month after enrolment