Hyperbaric OXygen therapy for ACute Acoustic Trauma

Phase 3

Recruiting

• Conditions: Acute Acoustic Trauma; Acute Hearing Loss; 10019243

• Registration Number: NL-OMON55905
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 84

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the absolute hearing gain on all affected<br /><br>frequencies (>= 20 dB) after between patients in HBOT5 and HBOT10 groups.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Additional audiometric outcomes include relative hearing gains and speech<br /><br>discrimination at 100%, these will be compared between the both treatment arms.</p><br>