NL-OMON55905招募中3 期
Hyperbaric OXygen therapy for ACute Acoustic Trauma - HOXACAT
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •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.
排除标准
- •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
- •- Current pregnancy.
- •- Use of adriamycin, bleomycin, cisplatin, or doxorubicin in previous six
研究者
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