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临床试验/NCT05372094
NCT05372094已完成不适用

Noise Reduction Preferences in Teenagers and Pre-teens

Sonova AG2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2023年2月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Sonova AG
入组人数
18
试验地点
2
主要终点
Subjective Rating of Listening Effort Questionnaire

研究概览

简要总结

Noise reduction preferences and blue tooth access to hearing aid streaming features will be evaluated in experienced hearing aid users age 10-17.

详细描述

The purpose of this study is to evaluate the preferences for hearing aid noise reduction settings in users age 10 -17, as well as to evaluate preferences for accessing the hearing aid Bluetooth streaming programs for this population. Subjective preferences will be obtained by having the participants listen to a noisy scene with different levels of noise reduction, to which they are blinded, and rate their preference. Blinded objective speech performance testing will be completed by a) finding the signal-to-noise ratio at which participant can correctly repeat back 50% of the target words, and b) measuring the percent of words correctly repeated during a noisy listening task. These tasks will be done using different levels of noise reduction. Subjective preferences for accessing Bluetooth streaming will also be obtained by asking participants which method they prefer (phone, hearing aid, or touch control).

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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

盲法说明

Participants will be blinded as to which noise reduction setting they are listening to during lab visit objective testing only.

入排标准

年龄范围
10 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • mild, moderate, or moderate-severe bilateral sensorineural hearing loss
  • native English speakers with ability to communicate verbally
  • able to read and follow directions
  • access to smartphone and willing to download a hearing aid app
  • experienced hearing aid user (6+ months)

排除标准

  • unable to follow verbal directions
  • unable to communicate verbally
  • unable to wear study devices for required home trials
  • active middle ear infection
  • unable to attend lab visits required for study

结局指标

主要结局

Subjective Rating of Listening Effort Questionnaire

时间窗: Day 14 of study, visit 2

Participant will rate perceived listening effort during a speech in noise task with different levels of noise reduction. Participants will rate how easy the task seemed using a sliding scale with 100 increments between two verbal anchors: "it was very easy" to "it was not easy at all". Higher scores indicate higher perceived listening effort. A rating of "0" would indicate "it was very easy" to understand the speech while a rating of "100" would indicate "it was not easy at all" to understand the speech.

次要结局

  • Subjective Preference Questionnaire for Hearing Aid Noise Reduction Settings(Day 1 of study, visit 1)
  • Physical Response Time(Day 14 of study, visit 2)
  • Subjective Questionnaire on Preference for Accessing Bluetooth on Phone(Day 28, visit 3)
  • Speech Reception Threshold(Day 28, visit 3)
  • Verbal Response Accuracy(Day 14 of study, visit 2)

研究者

发起方
Sonova AG
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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