In-Lab Evaluation of A Hearing Aid Housed in Ophthalmic Spectacles for Mild to Moderate Hearing Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Unaided and Aided speech in noise Matrix test
研究概览
简要总结
Evaluation of in-lab benefit for speech-in-noise intelligibility with the device for adults with mild to moderate hearing loss.
详细描述
This primary objective is to evaluate whether the device improves speech recognition in noise compared to the clinically relevant comparison condition of no treatment (unaided) for adults with mild to moderate hearing loss. The primary outcome will be measured using a clinically available test of speech recognition in noise that uses adaptive bracketing of signal to noise ratio (the Matrix test). The secondary outcome will also assess speech recognition in babble at ecologically valid fixed signal to babble ratios (The Connected Speech Test). Tertiary outcomes will examine device users' ratings of listening effort in noise with and without the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years and older
- •symmetrical bilateral mild to moderate sensorineural hearing loss
- •native speakers of English.
排除标准
- •those without hearing loss
- •those without symmetrical bilateral mild to moderate sensorineural hearing loss
- •those who do not wish to wear the test device instead of their own spectacles during the in-lab procedure
- •those who are not native speakers of English
- •those who have pacemakers, other implantable devices, or insulin pumps
研究组 & 干预措施
A prospective in-lab within-subjects design with repeated measures
Test of speech recognition in noise (the Matrix test). Assessment of speech recognition in babble (The Connected Speech Test). Device users' ratings of listening effort in noise with and without the device.
干预措施: Evaluation of speech-in-noise intelligibility and listening effort (Device)
结局指标
主要结局
Unaided and Aided speech in noise Matrix test
时间窗: 1 hour
Matrix Test with and without device. The outcome is Speech Reception Threshold (SRT) in dB SNR
Unaided and Aided Connected speech-in-noise tests
时间窗: 1 hour
Connected Speech Test with and without device. The outcome is the percentage score representing the number of key words correctly repeated
Unaided and Aided speech in noise Matrix test
时间窗: 1 hour
Matrix Test with and without device. The outcome is Speech Reception Threshold (SRT) in dB SNR
Unaided and Aided Connected speech-in-noise tests
时间窗: 1 hour
Connected Speech Test with and without device. The outcome is the percentage score representing the number of key words correctly repeated
次要结局
- Unaided vs Aided Ratings of Listening Effort(30 minutes)