STARFISH

Hearing loss is a common and disabling condition that may result from problems with the cochlea, an inner ear structure that senses sound and sends information to the brain. Loss of hearing due to damage to the cochlea can occur suddenly and without an obvious cause, a condition described as idiopathic sudden sensorineural hearing loss (ISSNHL). ISSNHL usually occurs in one ear, and can range from a mild hearing loss to a completely deaf ear.

The recovery of hearing following ISSNHL may be helped by urgent treatment with steroids, and this is the standard treatment that most doctors would recommend for the condition.

In the UK, steroids are commonly given for this condition in three forms: as tablets, as an injection through the ear drum, or by both routes at the same time. At the moment we do not know how best to give steroids for ISSNHL, but this study aims to identify the method that will provide the best recovery of hearing for patients with ISSNHL.

STARFISH is a pragmatic, multicentre, assessor-blinded, 3-arm randomised controlled trial with an internal pilot.

The participant follow up period is 12 weeks.

Suitable patients will be identified at Ear, Nose and Throat Unit within ~75 NHS Trusts across the UK.

The trial aim to recruit 525 adults with idiopathic sudden sensorineural hearing loss to take part.

• 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 (Prednisolone) and intratympanic (Dexamethasone) steroid as described above, with the first intratympanic injection occurring within 4 days of starting oral steroid use.

Primary Outcome

The absolute improvement in pure tone audiogram average at 12-week following treatment initiation (calculated at 0.5, 1.0, 2.0, 4.0 kHz dBHL)

Secondary Outcomes

• Functional hearing:
  • Speech, Spatial and Qualities of hear scale (SSQ)
  • Pure tone audiogram average at 6-week
  • Pure tone audiogram average across 4.0, 6.0 and 8.0 kHz
  • AB phoneme
  • Classification of recovery
• High frequency hearing threshold measured by the absolute improvement in pure tone audiogram average across 4.0, 6.0 and 8.0 kHz
• Extent of hearing recovery
• Time to recovery
• Associated Symptoms: dizziness and tinnitus (VRBQ & TFI)
• Adverse Events
• Health Economic (HUI3, ICECAP-A, Resource usage)

Optional

Weekly home hearing tests (speech and pure tone thresholds) on apps

Co-Chief Investigators: Dr James Tysome and Dr Matthew Smith

Trial Sponsor: University of Birmingham

Funder: National Institute For Health Research (HTA programme [Ref: NIHR131528]) - This study is funded by the NIHR Health Technology Assessment (HTA) programme (NIHR131528). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

EudraCT number:  2022-000085-17