Cochlear Implantation During Vestibular Schwannoma Removal or During Labyrinthectomy Surgery for Treatment of Meniere's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in Sound Detection Testing
研究概览
简要总结
This study is a prospective, clinical study to determine if it is safe and effective to use a cochlear implant over time in individuals undergoing removal of a vestibular schwannoma (VS), benign tumor of the hearing and balance nerve or undergoing a labyrinthectomy for treatment of Meniere's disease. Individuals undergoing these surgeries will be deaf on the surgical side after the procedure. Currently, cochlear implants are approved for use and not considered investigational in individuals with hearing loss on both sides. However, use of a cochlear implant for these patient populations (single-sided hearing loss) will be considered a new use of an approved device. Participants undergoing surgery to remove a VS or having a labyrinthectomy will have a cochlear implant inserted after the surgical procedure for clinical care. Approximately 4 weeks after surgery, participants will be fitted with an external speech processor on the surgical side that will stimulate the internal cochlear implant. Participants will return at the following intervals after the initial processor fitting: 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months. At each interval, participants will complete questionnaires on how they are hearing with the implant and their quality of life with the implant and be tested on their ability to hear sounds and understand speech. Potential risks are those associated with all cochlear implant surgeries, and include device failure resulting in removal of device, irritation or redness in surgical area and/or area where processor is attached, increased ringing in the ear, facial nerve stimulation and a change in the way speech and other sounds sound through the implant. Potential benefits to individual participants in this study include improvement in detection and speech understanding of the surgical ear. Participants may also experience improved abilities to locate sound and understand speech in noise as the result of having hearing on both sides.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of a vestibular schwannoma confirmed by a physician with an MRI and/or CT scan; Or have a diagnosis of Meniere's disease by a physician
- •Be scheduled to undergo surgery to remove the vestibular schwannoma through translabyrinthine approach; Or be scheduled to undergo a labyrinthectomy
- •Be English-speaking due to objective speech perception tasks. Non-English speakers may show a reduced speech perception score due to language differences
- •For patients undergoing tumor removal, tumor removal must allow preservation of the auditory division of the VIIIth cranial nerve
排除标准
- •Subjects with bilateral Meniere's disease or bilateral vestibular schwannomas
- •Inability to preserve the auditory division of the VIIIth cranial nerve during removal of vestibular schwannoma
- •Ossification or fibrosis of the cochlear found on preoperative imaging (CT or MRI) that precludes cochlear implantation
- •Active middle ear disease
- •Greater than 70 years of age
- •Vestibular schwannoma greater than 2 cm
- •Patient refusal of receiving pneumococcal vaccine
- •Any contra-indication(s) for undergoing surgery.
研究组 & 干预措施
Meniere's Disease/Vestibular Schwannoma
Individuals diagnosed with Meniere's disease and undergoing labyrinthectomy or diagnosed with vestibular schwannoma and undergoing surgical excision via translabyrinthine approach for treatment will receive cochlear implant at the time of surgery.
干预措施: Cochlear Implant (Device)
结局指标
主要结局
Change in Sound Detection Testing
时间窗: Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.
Sounds that vary in pitch (frequency) will be presented in a sound field to identify hearing thresholds in decibels (dB). Participant indicates when a sound is detected/perceived when listening with the cochlear implant. The softest sound at each specific frequency (125, 250, 500, 1000, 2000, 3000, 4000, 6000, 8000 Hertz (Hz)) will be recorded in dB hearing level.
Change in Speech Perception Testing
时间窗: Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.
Arizona (AZ) Bio sentences (speech perception test comprised of 660 unique sentences, presented in 33 independent lists of 20 sentences each) and the Maryland consonant-vowel nucleus-consonant (CNC) (10 phonetically balanced 50-word lists) word lists will be presented through a sound field speaker, and participant will be asked to repeat back the sentences and/or word that was heard. Background noise will be presented in conjunction with the sentences/words at various signals to noise levels (quiet \[no noise\], +0 dB and +5 dB signal to noise ratio). The percentage of sentences/words correctly repeated will be calculated for each test (AZ Bio, CNC) at each signal to noise level. Higher percentages indicate better word and sentence recognition ability.
Change in Sound Localization Testing
时间窗: Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.
Participant listens to bursts of sounds (100 trials of pink noise \[random noise having equal energy per octave and having more low-frequency components than white noise; the power per hertz decreases as the frequency increases\] presented randomly from seven speakers in a half-moon orientation and identifies which speaker presented the sounds. Two testing conditions will be evaluated (implant on, implant off). Total percentage of sounds correctly identified for each condition (0-100%) will be calculated, with a larger percentage indicating higher accuracy. Additionally, root mean square error (average of total degree of error when localizing) will be calculated for each trial.
次要结局
- Change in Speech, Spatial and Qualities of Hearing Scale (SSQ) Scores(Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.)
- Change in Tinnitus Handicap Inventory (THI) Scores(Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.)
- Change in Nijmegen Cochlear Implant Questionnaire (NCIQ) Scores(Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.)
研究者
Oliver Adunka
Professor-Clinical Otolaryngology
Ohio State University