Hearing Loss in Older Adults: A Randomized Controlled Trial of Immediate Versus Delayed Cochlear Implantation.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Cochlear
- 入组人数
- 1
- 试验地点
- 15
- 主要终点
- Hearing Handicap
研究概览
简要总结
This is a prospective, 1:1 randomized controlled trial of immediate versus delayed cochlear implantation (CI) on hearing handicap, communicative function, loneliness, mental wellbeing, and cognitive functioning. Participants are randomized 1:1 to an immediate cochlear implant intervention group versus a hearing aid control intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Community-dwelling
- •Proficient in English
- •Oral communicator
- •PTA (500, 1000 & 2000 Hz) ≥ 70 dB HL hearing loss duration ≥1 and no more than 30 years
- •Active daily hearing aid users
- •HHIE-S score greater than or equal to 24
- •MoCA score greater than or equal to 20
- •Post-linguistic onset sensorineural hearing loss and meet applicable FDA and/or Medicare candidacy criteria for cochlear implantation
- •Willing to consent for the study, to be randomized to either group, to utilize bimodal hearing for the duration of the trial (if clinically appropriate), and follow the study protocol
排除标准
- •Prelingual or perilingual severe-to-profound hearing loss
- •Previous cochlear implantation in either ear
- •Hearing loss of neural or central origin
- •Permanent conductive hearing impairment (e.g. otosclerosis)
- •Medical, audiological, or psychological conductions that might contraindicate participation in the clinical investigation
- •Self reported disability in 2 or more activities of daily living
- •Vision impairment worse than 20/40 on a near vision card
结局指标
主要结局
Hearing Handicap
时间窗: 6 months after enrollment
The SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. Assessment of the impact of cochlear implantation versus continued hearing aid is then calculated and the theoretical score could vary between -10 to + 10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing.
次要结局
未报告次要终点