Assessment of The Efficacy of Intratympanic Platelet Rich Plasma for Treatment of Sensorineural Hearing Loss.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Changes in Pure Tone Averages
研究概览
简要总结
Assessment of the efficacy of Intratympanic platelet rich plasma injection for treatment of idiopathic suden sensorineural hearing loss
详细描述
Sensorineural hearing loss is the collective term for hearing damage to the cochlea and auditory nerve and is by far the most common type of hearing loss in adults, accounting for over 90% of all cases. Sensorineural hearing loss is a heterogeneous disorder, which can arise due to damage to pathway for sound impulses from the hair cells of inner ear to auditory nerve and less commonly brain.
Sensorineural hearing loss is a challenge to physicians, as it progresses with age and causes significant reductions in quality of life and there are no treatments to reverse its effects, other than sound amplification with the use of hearing aids or direct auditory nerve stimulation via cochlear implantation.
Platelet-rich Plasma (PRP) Therapy is a cutting-edge procedure that is revolutionizing the hearing loss and deafness. Intratympanic instillation of Platelet-rich Plasma (PRP) does wonder to the hair cells of inner ear, thus improving the hearing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have sudden idiopathic sensorineural hearing loss
排除标准
- •patients has previous ear surgery.
- •patients has absent cochlea in CT or MRI
- •patients has Cancer,Chronic liver disease, Hemodynamic instability,Hypofibrinogenemia, Platelet dysfunction syndromes, Systemic disorder, sepsis, Low platelet count.
研究组 & 干预措施
platlet rich plasma
干预措施: Platelet Rich Plasma (Biological)
platlet rich plasma
干预措施: local anesthesia in external auditory canal (Drug)
platlet rich plasma
干预措施: Intratympanic Injection (Procedure)
结局指标
主要结局
Changes in Pure Tone Averages
时间窗: 6 weeks
Continuous pure tone averages calculated from pure tone audiometry will be summarized using the mean, standard deviation, median, 25th percentile, 75th percentile, minimum and maximum.
次要结局
未报告次要终点
研究者
Mahmoud Hassan Ali
Resident doctor at Otolaryngology Departement, Principal Investigator
Assiut University