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临床试验/NCT04882709
NCT04882709终止不适用

Using Headphone Presentation to Investigate Compression Strategy Modifications in Hearing Aids for Moderate-to-severe Hearing Loss

Sonova AG2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
Sonova AG
入组人数
12
试验地点
2
主要终点
Sound Quality Rating

研究概览

简要总结

The stimuli consist of speech in quiet, speech in noise, reverberant speech, and music recorded with different hearing aid settings, post-processed for headphone presentation and incorporated in an online sound survey. Participants will receive tablets and headphones to conduct a sound quality rating at home. The survey will involve a training session and within-subject repeated measures. Stimuli presentation will be randomized by sound quality rating tool.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

The acoustic output of the different devices had been recorded and the recordings have been presented in random order (random order created by the sound survey algorithm) to the participants in a digital sound survey, so neither the researcher nor the participant knew which recording the participant was listening to when rating.

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (18-99 years) with ≥3 months hearing aid experience
  • binaural, symmetric, sensorineural N3 to N4 hearing loss
  • able to use Android interface and receive a video call on phone/computer
  • fluent in English

排除标准

  • children/teenagers
  • normal hearing or hearing loss exceeding N4 by 10dB
  • cannot wear over-ear headphones

结局指标

主要结局

Sound Quality Rating

时间窗: 1 hour

Participants moved through a self-guided, double-blinded sound survey which presented sound samples of all hearing aid conditions (see Arms/Groups for conditions) and asked participants to rate the sound quality dimensions on a scale. The rating dimensions and scales were based on a sound quality rating guidance document by Delta Labs (Danmark) ranging from 0 to 100 with step sizes of 1 and descriptive markers at 0 (worst), 20, 40, 60, 80 and 100 (best) depending on the dimension (Reverberation (only assessed for Speech in Quiet and Reverberant Speech), Sound Source Localization, Sound Source Separation, and Timbral Balance). Overall Preference was implemented as a ranking according to the 5-point Mean Opinion Score (bad (1), poor (2), fair (3), good (4), excellent (5); MOS, International Telecommunication Union, 1996).

次要结局

未报告次要终点

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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