Evaluation of the Impact of Cochlear Implants on Cognition in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 主要终点
- What is impact on cognition of a cochlear implant in older adults
研究概览
简要总结
The subjects will be age 65 years and older, with no upper limit of age range with hearing loss that are candidates for standard-of-care cochlear implant.
Cognitive tests will be administered preoperative, and postoperative at 6 and 12 month, and 5 year intervals.
详细描述
Patients >65 year old who are cochlear implant candidates will be recruited for study participation. Candidacy criteria will be based on current FDA guidelines for cochlear implantation. After pre-operative cognitive testing, subjects will undergo cochlear implantation using standard operative techniques. Patient will have routine post-operative care and will follow up with audiology per standard post-activation routine - 1 week after activation, then monthly until a stable program is achieved. Hearing will be measured with standard audiometry to check for residual acoustic hearing, hearing in noise tests (HINT), aided thresholds, and consonant-nucleus-consonant (CNC) words at activation, 6 and 12 months, and 5 year post-operatively, and as often as needed in the interim to determine function.
Pre-operative and 6 and 12 month, and 5 year post-operative cognitive testing will be performed using a battery of tests that will differentiate verbal/auditory and non-verbal cognitive abilities.
Written informed consent will be sought from all individuals who will participate in the proposed project. Consent will be obtained by the principal investigator or key study personnel such as the research coordinator. When a potential participant has been identified, she/he will be visited in person. The participant will be given an overview of the study as well as written material that further explains the study and the responsibilities of the participant. Since some of our participants may have cognitive impairment, we will also make a determination about capacity to provide informed consent. Following presentation of the informed consent document, participants will be asked questions about the study (i.e. purpose, procedures, risks, and benefits). If these questions are adequately answered, then the participant will be judged to have capacity to provide informed consent. However, if these questions are not adequately answered, the participants will not be judged to have this capacity. In these latter cases, assent will be obtained from the participant and informed consent will be obtained from the participant's legally authorized representative (spouse, adult child
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subjects will be age 65 years and older, with no upper limit of age range with hearing loss that are candidates for a cochlear implant.
排除标准
- •Those patients who are not able to undergo cochlear implantation surgery due to medical co-morbidities would not be eligible for the study.
研究组 & 干预措施
Older Cochlear Implant Subjects
We will assign the study participants to a diagnostic intervention (cognitive testing) before and after their cochlear implant.
干预措施: Cognitive Testing (Other)
结局指标
主要结局
What is impact on cognition of a cochlear implant in older adults
时间窗: 4 years
We will measure cognitive function by administering the Trails A/B test.
Mini-mental State Exam (MMSE)
时间窗: Pre-operatively, at 6 months, 12 months, and five year post-operatively.
Mini-Mental State Examination (MMSE) measures global cognitive function. Score ranges from 0-30; a score of 0 indicates severe cognitive impairment and a score of 30 indicates no cognitive impairment. Higher scores indicate better outcome.
Digit Span test (verbal)
时间窗: Pre-operatively, at 6 months, 12 months, and five year post-operatively.
Measures simple attention. In the first part, subjects are required to recall and recite digits in forward sequence (0-16 points), the second part requires subjects to recall and recite digits in backward sequence (0-14 points). Higher scores indicate better outcome.
Stroop Color-Word Test (Golden version)
时间窗: Pre-operatively, at 6 months, 12 months, and five year post-operatively.
Stroop Color-Word Test measures sustained attention. Raw score is the number of answers correct out of 100. Higher scores = better outcome.
Hopkins Verbal Learning Test-Revised (HVLT-R)
时间窗: Pre-operatively, at 6 months, 12 months, and five year post-operatively
Measures verbal learning and memory. Score ranges from 0-36; a score of 0 indicates no words recalled and a score of 36 indicates perfect recall. Higher scores indicate better outcome
Hayling Sentence Completion Test
时间窗: Pre-operatively, at 6 months, 12 months, and five year post-operatively
Measures executive functioning. Overall scaled score ranges from 1-10; a score of 1 indicates impaired function and 10 indicates very superior function. Higher score indicates better outcome
Spatial Span Test (visuospatial)
时间窗: Pre-operatively, at 6 months, 12 months, and five year post-operatively
Assesses attention, short-term and working memory. Two parts, the first part requires subjects to physically point at the digits shown to them in forward sequence (0-16 points), the second part requires subjects to point the digits in backward sequence (0-16 points). Higher scores indicate better outcome.
d2 Test of Attention
时间窗: Pre-operatively, at 6 months, 12 months, and five year post-operatively
Assesses sustained and selective attention. The score is calculated as: Total Number of Items minus Errors. Higher scores indicate better outcome.
Brief Visuospatial Memory Test-Revised (BVMT-R)
时间窗: Pre-operatively, at 6 months, 12 months, and five year post-operatively.
Measures visuospatial learning and memory First Section assess immediate recall where raw scores range from 0-36; a score of 0 indicates no figures recalled and a score of 36 indicates perfect recall. Second Section assess delayed recall ( 25-minute delay) with a score range from 0-12. A higher score indicates better recall outcome.
Trail Making Test Part B
时间窗: Pre-operatively, at 6 months, 12 months, and five year post-operatively.
Executive functioning is scored by the total time in seconds required to complete the task. The time to complete each task is recorded as a score. A higher score indicates poor performance and less time indicates better performance.
次要结局
- What is the psychosocial impact of cochlear implants on older adults(4 years)
- Mood and Psychosocial impact of cochlear implants on older adults(Pre-operatively, at 6 months, 12 months, and five year post-operatively.)