Randomised controlled trial comparing conventional steroid treatment to conventional steroids plus hyperbaric oxygen treatment in sudden sensorineural hearing loss within two weeks of onset.

The Effectiveness of Steroids and Hyperbaric oxygen for sudden sensorineural hearing loss (SHOOSH): a randomised controlled trial.

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001495112

Acronym

SHOOSH

Enrollment

100

Registered

2019-10-29

Start date

2020-01-01

Completion date

2021-12-31

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This trial is to determine the efficacy of HBOT in addition to steroids in the treatment of ISSHL against conventional steroids alone. There has been increasing evidence of efficacy and a recent Cochrane review suggested a large well designed RCT is needed to understand the role of HBOT. There are wide differences in clinical management across Australia due to the lack of evidence of which strategy is best. This trial hopes to bring clarity to the best management in terms of hearing outcomes.

Interventions

Hyperbaric oxygen treatment (100% oxygen via hood or face mask for 85 mins in a compressed chamber) daily at 2.4 ATA for 20 days with a 5 min air break after 20 mins at depth. Administered in accordance with the Australian and New Zealand Standard (ASNZ 4774.2) by a qualified specialist in hyperbaric medicine. Patients have daily attendance as a hospital outpatient attendance recorded in their medical record.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Documented diagnosis of ISSHL as defined by the criteria of NIDOCD. 2. Presentation within two weeks of onset of symptoms. 3. Adult aged 18 or over. 4. Normal hearing in contralateral ear. 5. Exclusion of retro-cochlear mass. 6. No contraindication to oral steroids. 7. Fitness for compression in a HBOT chamber.

Exclusion criteria

1. Contraindication to HBOT as assessed by a hyperbaric physician. 2. Unstable Type 1 diabetes. 3. Other causative agent for hearing loss suspected (e.g. drugs, acoustic trauma). 4. History of middle ear surgery which in the ENT surgeon’s opinion would exclude the patient from being able to be pressurized.

Outcome results