Hyperbaric oxygen for hearing loss and tinnitus

For adults with sudden sensorineural hearing loss, with or without tinnitus, and with an onset within the past 14 days, does the application of hyperbaric oxygen therapy, in addition to the standard therapy of oral steriods, result in an improvement in hearing, tinnitus or quality of life?

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000619246

Enrollment

Registered

2009-07-27

Start date

2010-02-22

Completion date

2014-02-15

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

In this study, we aim to show whether hyperbaric oxygen therapy (HBOT) is beneficial for patients with sudden onset of hearing loss (with or without a ringing in the ears) where no cause can be found for the hearing loss.

Interventions

Hyperbaric oxygen therapy (HBOT). Daily sessions Monday to Friday for 2 hours at 2.0 ATA (202.6 kPa) while breathing 100% oxygen. Total number of treatments 15 over three consecutive weeks. Participants will also take the standard medication (see below) starting on the same day as the first hyperbric oxygen session.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

All adult patients (>18 yrs) presenting with idiopathic sudden sensorineural hearing loss (ISSHL), with or without tinnitus and where the first hyperbaric session can be administered within 14 days of the onset of symptoms. Diagnosis will exclude other causes of sudden hearing loss historically (e.g. Menieur’s disease, barotrauma, noise-induced hearing loss, ototoxic drugs) and by a magnetic resonance image (MRI) of the affected side to exclude an acoustic neuroma or other tumour.

Exclusion criteria

Patient refusal (HBOT will not be offered to those who refuse to participate), Contraindications to HBOT including inability to equalise the middle ear or respiratory sinuses, claustrophobia, pneumothorax, previous bleomycin administration or severe respiratory disease with carbon dioxide retention, presence of hearing decrement (documented) for greater than two weeks.

Outcome results