Idiopathic sudden sensorineural hearing loss Ear, Nose and Throat A sudden loss of hearing (over 3 days or less), due to inner ear damage, with no obvious cause
Conditions
Interventions
Oral steroid (Prednisolone) 1mg/Kg/day up to 60mg/day for 7 days
or
Intratympanic steroid (Dexamethasone) three intratympanic injections 3.3mg/ml or 3.8mg/ml spaced 7±2 days apart
or
Combined oral (Pr
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 13/11/2025: 1. Adults aged 18 years or over 2. Diagnosis of new-onset ISSNHL: a new increase in sensorineural thresholds of 30 decibels (dBHL) or greater affecting each of three contiguous pure-tone frequencies (out of 0.5, 1.0, 2.0, 4.0 kilohertz (kHz)) confirmed with a pure tone audiogram, having an onset over a period of 3 days or less according to the patient's history* 3. Onset of hearing loss within 4 weeks prior to randomisation 4. English spoken as a first or second language *Where audiometry is not available prior to the ISSNHL and there is a history is of equal hearing in both ears prior to the sudden loss, hearing loss will be defined in relation to the opposite ear’s thresholds. Where audiometry is not available prior to the ISSNHL and there is a history of different hearing in both ears prior to the sudden loss, then the candidate can only be included if the ISSNHL occurred in the better hearing ear and the measured thresholds are at least 30dB below the contralateral ear at three contiguous pure-tone frequencies (out of 0.5, 1.0, 2.0, 4.0 kilohertz (kHz)) confirmed with a pure tone audiogram. Previous inclusion criteria: 1. Adults aged 18 years or over 2. Diagnosis of new-onset ISSNHL- sensorineural hearing loss of 30 decibels (dBHL) or greater occurring within a 3-day period and including 3 contiguous pure-tone frequencies (out of 0.5, 1.0, 2.0, 4.0 kilohertz (kHz)) confirmed with a pure tone audiogram occurring within a 3-day period (based on participant-reported history) 3. Onset of hearing loss within 4 weeks prior to randomisation 4. English spoken as a first or second language
Exclusion criteria
Exclusion criteria: 1. Identified cause for hearing loss (not idiopathic) 2. Bilateral ISSNHL 3. Received prior steroid treatment for the same episode of ISSNHL 4. Medical contraindication to high dose systemic steroids 5. Previous history of psychosis 6. On oral steroid therapy for another condition 7. Known adrenocortical insufficiency other than exogenous corticosteroid therapy 8. Hypersensitivity to the active substance or to any of the excipients 9. Has a systemic infection unless specific anti-infective therapy is employed 10. Has ocular herpes simplex 11. Has ipsilateral acute or chronic active middle ear disease (including acute otitis media, chronic suppurative otitis media and cholesteatoma, excluding dry perforation) 12. Does not have the capacity to provide written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The absolute improvement in pure tone audiogram average (calculated at 0.5, 1.0, 2.0, 4.0 kHz) at 12 weeks after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| At 6 and 12 weeks post randomisation: 1. Functional hearing 1.1. Hearing related to speech: using The Speech, Spatial and Qualities of hearing scale (SSQ). SSQ is a validated measure, in the form of a short questionnaire, known to provide a good representation of the functional relationship with speech in everyday life and has been used to assess the disability of unilateral hearing loss seen in ISSNHL, providing disability scores associated with different aspects of hearing. 1.2. The absolute improvement in pure tone audiogram average (calculated at 0.5, 1.0, 2.0, 4.0 kHz). 1.3. Actual hearing thresholds measured by pure tone audiogram average following treatment initiation (calculated at 0.5, 1.0, 2.0, 4.0 kHz). 1.4. High frequency hearing threshold measured by the absolute improvement in pure tone audiogram average across 4.0, 6.0 and 8.0 kHz. 1.5. Recovery of speech perception: using Arthur Boothroyd (AB) word lists scored by phoneme. 1.6. Extent of hearing recovery: using an established classification of recovery (complete/partial/none) based on pure tone audiogram and speech perception 1.7. Time to hearing recovery: using online digits-in-noise and pure tone tests (Optional and recommended weekly where done). 2. Associated Symptoms 2.1. Dizziness: using the Vestibular Rehabilitation Benefit Questionnaire (VRBQ). 2.2. Tinnitus: using the Tinnitus Functional Index (TFI). 3. Adverse Events (AEs) 3.1. Adverse events relevant to the interventions 4. Health Economic Assessment 4.1. Two tools will be used to assess health economics: the Health Utilities Index 3 (HUI3), a participant reported assessment of health-related quality of life suited to hearing loss, and ICEpop CAPability measure for Adults (ICECAP-A), a participant reported measure of capability for the adult population 4.2. Resource usage | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactKaren James
Outcome results
None listed