NCT05848804招募中不适用
Linus Health Hearing Screening Clinical Study
Linus Health, Inc.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年12月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Hearing Thresholds
研究概览
简要总结
The objective is to compare the Linus Health Hearing Screener (LHHS) to established hearing screening methods performed by a hearing specialist. We will perform an in-office speech hearing test and compare the thresholds with those measured from the iPad at a distance of 1ft with a sound pressure level (SPL) (dBA) meter
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants must be (1) Those with a range of hearing ability but not deaf; (2) 55+ years old; (3) able to use an iPad and Apple Pencil; (4) as close to their normal hearing conditions as possible: if they wear hearing aids normally they should have them during the assessment; if not, they should not wear them; (5) able to provide written informed consent in the Institutional Review Board-approved informed consent form; (6) willing and able to comply with all study procedures as outlined in the informed consent; and (7) fluent in English.
排除标准
- •Exclusion criteria include (1) individuals who are not able to understand or willing to comply with the directions for the administration of neuropsychological tests; (2) the presence of a major psychiatric upset such as bipolar disorder; (3) present with major medical problems such as cancer or epilepsy. Study staff will review potential participants who do not have dementia and can be approached about the study.
结局指标
主要结局
Hearing Thresholds
时间窗: 1 Year
The objective is to compare the Linus Health Hearing Screener (LHHS) to established hearing screening methods performed by a hearing specialist. We aim to perform an in-office hearing test and compare the thresholds with those measured from the iPad at a distance of 11ft with an SPL (dBA) meter. Comparing hearing test results between the LHHS and the results of a lab grade audiogram.
次要结局
未报告次要终点
研究者
研究点 (1)
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