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临床试验/NCT05435612
NCT05435612招募中不适用

Evaluation of Rehabilitation Results in the Single-sided Deafness/Asymmetrical Hearing Loss With Cochlear Implantation

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Objective electroencephalography-based assessment(EEG)

研究概览

简要总结

Single-sided deafness (SSD) refers to severe to profound sensorineural hearing loss on one side (average pure-tone hearing threshold≥70 dB HL at 0.5, 1, 2, and 4kHz) while the opposite side maintains normal hearing or mild hearing loss (30 dB HL). Asymmetrical hearing loss (AHL) refers to severe to profound sensorineural hearing loss in the bad ear (average pure-tone hearing threshold≥70 dB HL at 0.5, 1, 2, and 4kHz) and mild to moderate hearing loss in the contralateral ear. Moderate hearing loss (30≤mean pure-tone hearing threshold≤55dBHL). It is generally acknowledged that SSD is a particular clinical manifestation of AHL. The number of people who have hearing loss accounts for 5.3% of the total population, with children for 9%. According to the Second National Sampling Survey on Disabled Persons, China has 27.8 million people with hearing disabilities. The incidence of SSD adults in the United States is 7.2%, with 60,000 new cases per year, compared with 7,500 new patients with SSD annually in the UK. The incidence of SSD in neonates is 0.04%-0.34%, and it ranges from 0.1% to 0.5% in children and adolescents. The etiology of congenital SSD is primarily unknown, which is related to genes. Among the causes of acquired SSD, sudden deafness is the most common. Other causes include head trauma, Meniere's disease, labyrinthitis, unilateral acoustic neuroma, middle ear surgery, ototoxic drug exposure, Virus infection, noise-induced deafness, senile deafness, etc.

SSD and AHL impede intellectual development and speech development in children and adolescents, which is associated with the side of hearing loss. For example, children with right-sided hearing loss have relatively poor language learning, logical thinking, and divergent thinking. In contrast, children with left-sided hearing loss have weaker analytical, comprehensive and visual memory abilities and relatively poor spatial imagination and visual-motor coordination. In addition, the lack of long-term monaural listening and sound source localization makes SSD children require excessive concentration, which is prone to fatigue and behavioral problems, and their academic performance is lower than that of normal children.

详细描述

Current options for hearing interventions for patients with SSD are air conduction hearing aids, bone conduction hearing aids and cochlear implants. Attributed to the United States Food and Drug Administration (FDA) approval of one manufacturer's CI for patients aged five years and older with SSD in 2019, CI has been considered by the growing population. However, few studies on CI in patients with SSD, especially in China. Therefore, the study aims to evaluate the efficacy of CI in SSD patients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 12 years old and above
  • Language ability: postlingual deafness, able to cooperate with sentence test in noise
  • Normal mental, intelligence and motor development
  • Patients who meet the diagnosis of single-sided deafness and asymmetric hearing loss

排除标准

  • Cochlear malformation (except large vestibular aqueduct syndrome)
  • Retrocochlear lesions
  • Incomplete implantation of cochlear implant electrodes
  • Non-Chinese Mandarin communication

结局指标

主要结局

Objective electroencephalography-based assessment(EEG)

时间窗: The test is conducted 12 months after CI activation.

EEG is a non-invasive objective assessment technique that records brain activity along with specific neural pathways. we utilize cortical auditory evoked potential (CAEP) and event-related potentials(ERP) to obtain time-domain analysis.

speech recognition

时间窗: The tests are conducted 12 months after CI activation.

Both speech recognition score and speech recognition threshold are conducted to assess the auditory sensitivity and articulation of the spoken language. That is to evaluate the subjects' ability to recognize and understand speech in actual communication.

sound localization

时间窗: The test is conducted 12 months after CI activation.

180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation).

次要结局

  • NCIQ (Nijmegen Cochlear Implant Questionnaire)(The test is conducted 12 months after CI activation.)
  • SSQ12 (Speech, Spatial and Qualities of Hearing Scale)(The test is conducted 12 months after CI activation.)
  • THI (Tinnitus Handicap Inventory)(The test is conducted 12 months after CI activation.)
  • QLBHE (Quality of Life for Bilateral Hearing Effect)(The test is conducted 12 months after CI activation.)

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

YangShiming

College of Otolaryngology Head and Neck Surgery, Chinese PLA General Hospital

Chinese PLA General Hospital

研究点 (1)

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