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临床试验/ACTRN12616001359426
ACTRN12616001359426已完成未知

The effectiveness of hyperbaric oxygen therapy on pure tone audiogram outcome of patients with sudden sensorineural hearing loss. A prospective, randomized, interventional, controlled clinical trial.

Medical School of Aristotle University of Thessaloniki0 个研究点目标入组 50 人开始时间: 2016年9月29日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
50

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Idiopathic sudden sensorineural hearing loss

排除标准

  • 1)Patients with bilateral sudden sensorineural hearing loss.
  • 2)Patients who seek assistance after more than 7 days from the presence of symptoms.
  • 3)Patients who have already received another treatment for sudden sensorineural hearing loss.
  • 4)Patients with other causes of sudden sensorineural hearing loss such as autoimmune disease, Meniere disease, use of ototoxic agents, syphilis, trauma.
  • 5)Acoustic neuroma or demyelinating disease in MRI or other lesion in the cerebellopontine angle.
  • 6)Patients younger than 18 years old.
  • 7)Pregnancy.
  • 8) Contraindications to HBOT such as tension or untreated or recent pneumothorax, administration of certain drugs (Bleomycin, Cisplatin, Disulfiram, Doxorubicin), untreated epilepsy or seizures, congenital spherocytosis, upper respiratory infection, heart failure, chronic obstructive pulmonary disease, claustrophobia.
  • 9)Glaucoma.
  • 10)Mental disorders.
  • 11)Middle ear disease.
  • 12)Diabetes mellitus.
  • 13)Difficult to treat hypertension.
  • 14)Contraindications of steroids administration (peptic ulcer disease, osteoporosis, immunosuppression).

研究者

发起方
Medical School of Aristotle University of Thessaloniki

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