Acute acoustic trauma
Conditions
Interventions
Trade Name: Oxygen
Product Name: Oxygen
Product Code: RVG 35329
Pharmaceutical Form:
Trade Name: Oxygen
Product Name: Oxygen
Product Code: RVG 35329
Pharmaceutical Form:
Sponsors
Amsterdam University Medical Centers, location AMC
Eligibility
Sex/Gender
All
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 84 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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 |
|---|---|
| Primary end point(s): The main study endpoint is the absolute average hearing gain on all affected frequencies at one month of 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). ;Main Objective: The objective of this study is to investigate whether hyperbaric oxygen therapy twice-daily for five days (HBOT5) is superior to hyperbaric oxygen therapy once daily for ten days (HBOT10) in obtaining hearing loss recovery after AAT. This will be determined by comparing audiometric outcomes at final follow-up.;Secondary Objective: Not applicable;Timepoint(s) of evaluation of this end point: At 1 month after acoustic trauma | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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. ;Timepoint(s) of evaluation of this end point: At 1 month after acoustic trauma | — |
Countries
Netherlands
Contacts
Public ContactCoordinating Investigator
Amsterdam University Medical Centers, location AMC
Outcome results
None listed