New Approach to Objectively Measure Social Engagement in Older Adults With Hearing Loss
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Audio sensor- speech activity
研究概览
简要总结
The goal of this clinical trial is to learn if hearing devices, like hearing aids, 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
- •Group 1- older adults with normal hearing defined as speech frequency PTA <25dB HL in bilateral ears
- •Group 2- older adults with bilateral hearing loss who are not using hearing aids
- •Group 3- older adults with bilateral hearing loss, who are currently using hearing aids
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 (hearing aid users)
Participants with bilateral hearing loss (defined as those with speech-frequency pure-tone average >=25 dB HL bilaterally) and currently using hearing aids.
干预措施: Hearing aid use (Device)
Adults without hearing loss
Hearing loss defined as speech-frequency pure-tone average >=25 dB HL bilaterally
Adults with hearing loss (non-hearing aid users)
Participants with bilateral hearing loss (defined as those with speech-frequency pure-tone average >=25 dB HL bilaterally) and not currently using hearing aids.
结局指标
主要结局
Audio sensor- speech activity
时间窗: Baseline and 4-month after hearing aid use
The audio sensor employs deep-learning-based multimodal speech pattern modeling of participants' own voice activities to extract speech arousal and speech activities. Speech activity measures include the intersession time (the interval between speech sessions, representing the frequency of conversation engagement).
Audio sensor- speech arousal
时间窗: Baseline, 4-month after hearing aid use
The audio sensor employs deep-learning-based multimodal speech pattern modeling of participants' own voice activities to extract speech arousal and speech activities. Speech arousal measures include the percentage of strong arousals, serving as a proxy of enhanced engagement in conversations.
次要结局
- EEG Measures(Baseline, 4-month after hearing aid use)
- Cognitive test- MoCA(Baseline and 4-month after hearing aid use)
- UCLA Loneliness Scale(Baseline, optional 4 months follow-up)
- Lubben Social Network Scale (LSNS-6)(Baseline, optional 4 months follow-up)
- Duke Social Support Index (DSSI-11)(Baseline, optional 4 months follow-up)
- Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S)(Baseline, optional 4 months follow-up)
- Generalized Anxiety Disorder 7-item (GAD-7) Scale(Baseline, optional 4 months follow-up)
- Center for Epidemiologic Studies Depression Scale (CES-D)(Baseline, optional 4 months follow-up)
- Short Form Health Survey - 12 Item (SF-12)(Baseline, optional 4 months follow-up)
- Short Assessment of Health Literacy (SAHL)(Baseline, optional 4 months follow-up)
研究者
Janet Choi
Assistant Professor
University of Southern California