Additional oxygen under high pressure for acute hearing loss.

Phase 1

• Conditions: Acute acoustic trauma; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2020-005741-17-NL
• Lead Sponsor: Amsterdam University Medical Centers, location AMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-07
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• 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.

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

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 clinical trial of medicinal product
• Study Design: Not specified