Idiopathic sudden sensorineural hearing loss
Conditions
Interventions
Trade Name: Prednisolut® 250 mg
Pharmaceutical Form: Powder and solvent for solution for injection
Pharmaceutical form of the placebo: Powder and solvent for solution for injection
Route of administra
Sponsors
Martin-Luther-Universität Halle-Wittenberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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 =65 years) yes F.1.3.1 Number of subjects for this age range 156
Exclusion criteria
Exclusion criteria: -recurrent ISSHL at the affected side (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy (hearing threshold improvement) of high dose systemic glucocorticosteroids (“steroids”) versus standard of care (standard dose systemic steroids) for the treatment of unilateral idiopathic sudden sensorineural hearing loss, when given as a primary therapy;Secondary Objective: To assess the safety (hearing threshold improvement) of high dose systemic glucocorticosteroids (“steroids”) versus standard of care (standard dose systemic steroids) for the treatment of unilateral idiopathic sudden sensorineural hearing loss, when given as a primary therapy;Primary end point(s): Average change in hearing thresholds (pure-tone average of the 3 most affected contiguous frequencies) ;Timepoint(s) of evaluation of this end point: 30 days after enrolment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -average change in pure tone hearing level (3PTA0,5-2kHz [Fletcher-Typ] und 4PTA0,5-4kHz) 30 days after enrolment -percentage of patients with complete, partial or no improvement of hearing -average change in percentage of ear-specific masked monosyllabic words understood correctly at 65 and 80 dB SPL -patient self evaluation, quality of life and communication competence (patient questionnaires) -percentage of patients needing a hearing aid/ cochlear implant -percentage of patients with new or worsened arterial hypertension at day 5 (office blood pressure >140 mmHg syst. or >90 mmHg diast. or both) -percentage of patients with altered glucose tolerance at day 5 (to be detected by HOMA-IR) -need for rescue therapy -occurrence and extent of tinnitus one and six month after enrolment ;Timepoint(s) of evaluation of this end point: 30 days and 180 days after enrolment | — |
Countries
Germany
Contacts
Public ContactKKSH
Coordinating Centre for Clinical Trials University of Halle (KKSH)
Outcome results
None listed