Hyperbaric OXygen therapy for ACute Acoustic Trauma - HOXACAT

Amsterdam University Medical Centers, location AMC0 个研究点目标入组 84 人开始时间: 2021年8月7日最近更新: 2021年8月30日

试验速览

暂无简介。

•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

•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.

发起方

Amsterdam University Medical Centers, location AMC