Hearing Loss and Brain Health Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility- Proportion of enrolled participants who complete all study periods
研究概览
简要总结
Hearing loss is a prevalent and modifiable risk factor for cognitive decline and dementia in older adults, yet access to hearing care remains limited. Over-the-counter (OTC) hearing aids represent a promising and scalable strategy to expand access, particularly for individuals at elevated risk for dementia who may benefit most from earlier intervention. This pilot study aims to evaluate the feasibility and acceptability of OTC hearing aid use among older adults. Participants aged ≥50 years will undergo standardized hearing screening to identify bilateral, mild-to-moderate hearing loss. Eligible participants will be randomized to one of two sequences: (1) immediate intervention: 3-mo using OTC hearing aids or (2) waitlist control: 3-mo without devices followed by OTC hearing aid use after 3 months. Feasibility outcomes include study enrollment and retention, protocol adherence, and average daily device use determined by data-logging. Acceptability outcomes will be assessed using the International Outcome Inventory for Hearing Aids (IOI-HA), device satisfaction ratings, and participant intention to continue hearing-aid use. Hearing outcomes include validated questionnaires on hearing and listening efforts. Findings will inform the design of larger trials aimed at improving access to hearing care and promoting cognitive health.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 50 years
- •Known APOE status
- •Bilateral mild to moderate sensorineural hearing loss
- •No current use of hearing aids or cochlear implants
- •No diagnosis of dementia and able to provide informed consent
- •Able to complete questionnaires and follow instructions in English
- •Willing and able to comply with study procedures, follow-up visits, and hearing-aid use
排除标准
- •Clinical diagnosis of dementia
- •Severe or profound hearing loss
- •Self-reported congenital hearing loss
- •Absence of an ear canal due to medical conditions or prior surgical procedures
- •unwillingness to wear OTC hearing aids regularly (>=4 hours/day)
- •medical contraindication to use hearing aids (e.g., actively draining ear)
- •Known retrocochlear pathology
- •Severe uncorrected visual impairment or significant manual dexterity limitations that prevent handling the device
研究组 & 干预措施
Immediate Intervention
Immediate Intervention: 3-month of OTC hearing aid use
干预措施: Over-The-Counter (OTC) hearing aid (Device)
Waitlist control
Waitlist control: Basic patient education on hearing loss without OTC hearing aid for 3 months, followed by OTC hearing aid fitting
干预措施: Over-The-Counter (OTC) hearing aid (Device)
结局指标
主要结局
Feasibility- Proportion of enrolled participants who complete all study periods
时间窗: Baseline, 2-months, 4-months, and 6-months follow up
Feasibility- Proportion of enrolled participants who complete all study periods
Feasibility - Enrollment rate (% eligible who consent)
时间窗: Baseline
Feasibility - Enrollment rate (% eligible who consent)
Feasibility - Study visit completion rate (% of planned visits completed)
时间窗: Baseline, 2-months, 4-months, and 6-months follow up
Feasibility - Study visit completion rate (% of planned visits completed)
Feasibility - Frequency of device troubleshooting encounters
时间窗: Baseline, 2-months, 4-months, and 6-months follow up
Feasibility - Frequency of device troubleshooting encounters
Feasibility - Percentage achieving >= 4hours/day of objective wear time
时间窗: Baseline, 2-months, 4-months, and 6-months follow up
Feasibility - Percentage achieving \>= 4hours/day of objective wear time
Feasibility - Hearing aid use adherence (mean daily wear time from data-logging)
时间窗: Baseline, 2-months, 4-months, and 6-months follow up
Feasibility - Hearing aid use adherence (mean daily wear time from data-logging)
Acceptability - Intention to continue use after study completion
时间窗: Baseline, 2-months, 4-months, and 6-months follow up
Acceptability - Intention to continue use after study completion
Feasibility- Proportion of enrolled participants who complete all study periods
时间窗: Baseline, 2-months, 4-months, and 6-months follow up
Feasibility- Proportion of enrolled participants who complete all study periods
Feasibility - Enrollment rate (% eligible who consent)
时间窗: Baseline
Feasibility - Enrollment rate (% eligible who consent)
Feasibility - Study visit completion rate (% of planned visits completed)
时间窗: Baseline, 2-months, 4-months, and 6-months follow up
Feasibility - Study visit completion rate (% of planned visits completed)
Feasibility - Frequency of device troubleshooting encounters
时间窗: Baseline, 2-months, 4-months, and 6-months follow up
Feasibility - Frequency of device troubleshooting encounters
Feasibility - Percentage achieving >= 4hours/day of objective wear time
时间窗: Baseline, 2-months, 4-months, and 6-months follow up
Feasibility - Percentage achieving \>= 4hours/day of objective wear time
Feasibility - Hearing aid use adherence (mean daily wear time from data-logging)
时间窗: Baseline, 2-months, 4-months, and 6-months follow up
Feasibility - Hearing aid use adherence (mean daily wear time from data-logging)
Feasibility - Protocol adherence rate (% completing scheduled assessments)
时间窗: Baseline, 2-months, 4-months, and 6-months follow up
Feasibility - Protocol adherence rate (% completing scheduled assessments)
Feasibility - Retention rate (% completing follow-up visits)
时间窗: Baseline, 2-months, 4-months, and 6-months follow up
Feasibility - Retention rate (% completing follow-up visits)
Acceptability - International Outcome Inventory for Hearing Aids
时间窗: Baseline, 2-months, 4-months, and 6-months follow up
International Outcome Inventory for Hearing Aids
Acceptability - Intention to continue use after study completion
时间窗: Baseline, 2-months, 4-months, and 6-months follow up
Acceptability - Intention to continue use after study completion
次要结局
- Hearing Handicap Inventory - Screening Version(Baseline, at the end of period 1 (4-week from baseline), at the end of period 2 (8-week from baseline))
- Vanderbilt fatigue scale(Baseline, 2-months, 4-months, and 6-months follow up)
研究者
Janet Choi
Assistant Professor
University of Southern California