NCT07584837尚未招募不适用
Cochlear Implantation and Social Outcomes
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to learn if hearing devices, like cochlear implants, affect social and cognitive function of older adults. The main questions the researchers want to answer are:
- How social are older adults with hearing loss before and after using hearing devices?
- How well do older adults with hearing loss think before and after using hearing devices?
- For older adults who have hearing loss and use hearing devices, do changes in social interaction explain changes in how well they think (cognitive function)?
- Do brainwaves (EEGs) in older adults with hearing loss change after using hearing devices?
- Are there differences in how social older adults with hearing loss are compared to older adults without hearing loss?
What Participants Will Do:
- Participants will take questionnaires for around 60 minutes. Questionnaires will ask participants about their background, health, hearing, and how social they are. Another set of questionnaires will check their thinking ability or cognition.
- Participants will wear an audio sensor (TILES Audio Recorder on Jelly Mobile phone) for 2 weeks. The sensor will collect and store information about a participant's voice during conversations. Once the device has information about a participant's voice such as pitch and tone it will store this information and delete the audio recording. Words spoken during conversations will be deleted.
- (Optional) Participants can choose to participate in a 45-60-minute EEG (electroencephalogram) recording session. Participants will have sensors placed on top of their heads. Sensors will record the participants' brainwaves. Sounds will be played to see how participants' brainwaves change when they hear sounds. Eligible participants will be invited to participate in 4-month follow-up study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >= 60 years
- •English or Spanish speaking
- •older adults with bilateral moderate to profound sensorineural hearing loss who are candidates for cochlear implants or have undergone cochlear implantation.
排除标准
- •Age <60 years
- •Unable to complete questionnaires in English or Spanish
研究组 & 干预措施
Adults with bilateral hearing loss (cochlear implant users or candidates)
Participants with bilateral moderate to profound hearing loss who are candidates for cochlear implant or currently using cochlear implants
干预措施: Cochlear implant (Procedure)
结局指标
主要结局
未指定
次要结局
- EEG Measure - Mismatch negativity amplitude(Baseline, optional 4-month follow-up)
- EEG Measure - Mismatch negativity latency(Baseline, optional 4-month follow-up4-month follow-up)
- EEG Measure - P300 amplitude(Baseline, optional 4-month follow-up)
- EEG Measure - P300 latency(Baseline, optional 4-month follow-up)
研究者
Janet Choi
Principal Investigator
University of Southern California
研究点 (1)
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