Acute Acoustic Trauma Acute Hearing Loss
Conditions
Interventions
The investigation treatment is hyperbaric oxygen therapy twice daily for five
days while the comparator treatment is hyperbaric oxygen therapy once daily for
ten days. Hyperbaric oxygen therapy will
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
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 Otorhinolaryngology 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.
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 hearing gain on all affected frequencies (>= 20 dB) after between patients in HBOT5 and HBOT10 groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional audiometric outcomes include relative hearing gains and speech discrimination at 100%, these will be compared between the both treatment arms. | — |
Countries
Netherlands
Outcome results
None listed