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

Phase 1

• Conditions: Idiopathic sudden sensorineural hearing loss; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2015-002602-36-DE
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-08
• Last Update Posted: 14 April 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 312

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 < 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

Exclusion Criteria

-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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): -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)<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<br>;Timepoint(s) of evaluation of this end point: 30 days and 180 days after enrolment