Acute Acoustic Trauma
Conditions
Interventions
HBOT twice daily for 5 days + corticosteroids vs HBOT once daily for 10 days + corticosteroids.
Sponsors
Amsterdam UMC, location AMC
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Diagnosed with AAT based on audiometry after high impact noise-exposure at the Department of Otorhinolaryngology, Central Military Hospital. - First visit to the Department of Otolaryngology between 24 and 72 hours after the acoustic trauma. - Age = 18 years old. - Minimum hearing loss: = 30 dB on one tested frequency, or = 25 dB on two tested frequencies, or = 20 dB on three tested frequencies. When a previous audiogram is known, then the additional hearing loss due to AAT should be minimal the above.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded: - Subject does not speak fluent Dutch - History of idiopathic sudden sensorineural loss. - History of radiation therapy in the head and neck region. - Previous acute acoustic trauma (before current trauma) with objectified hearing loss. - Current or previous use of ototoxic drugs with objectified complaints before the current visit. - Known presence or history of vestibular schwannoma or cholesteatoma. - Current otitis media. - Epilepsy. - Known presence of untreated pneumothorax. - Known Chronic Obstructive Pulmonary Disease Gold IV grade or other pulmonary disease with severe air trapping. - Known severely reduced cardiac ejection fraction. - Implanted device that is not proven to be compatible with HBOT. - Claustrophobia that interferes with taking place in hyperbaric chamber. - Inability to equalize middle ears using Valsalva manoeuvre. (If so, patients are offered tympanostomy tubes if they wish to participate before being excluded.) - Current pregnancy. - Use of adriamycin, bleomycin, cisplatin, or doxorubicin in previous six months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is the absolute average hearing gain on all affected frequencies at three months follow-up. Affected is defined as the frequencies that have = 20 dB hearing loss on pre-treatment audiogram compared with: 1) a previous audiogram of the affected ear that was produced within a year prior to the current visit; or 2) the unaffected ear; or In case both ears are affected, affected frequencies will be defined as those frequencies that do not comply with the Ministry of Defence hearing standard (maximum accepted hearing impairment of 20 dB at frequencies lower than 3 kHz and maximal hearing impairment of 30 dB at frequencies of 3 kHz or higher). | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional audiometric outcomes include relative hearing gains on all affected frequencies, word recognition (hearing level at which 100% of words can be discriminated) and word recognition (% of words recognized) at 80 dB in case 100% is not yet reached at that level. | — |
Contacts
Public ContactRobert Weenink
Amsterdam UMC, location AMC
Outcome results
None listed