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临床试验/NCT05054816
NCT05054816已完成不适用

Speech Locator In-car Performance Evaluation

Sonova AG1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年2月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Sonova AG
入组人数
20
试验地点
1
主要终点
Speech Clarity

研究概览

简要总结

Listeners will conduct sound quality ratings of recordings talkers in a moving car processed using three different microphone processing strategies: an investigational adaptive directional microphone, an omnidirectional microphone and a fixed directional microphone. Participants will listen to the recordings streamed via commercially-available and individually-prescribed hearing aids, and conduct ratings onsite in the lab. The procedure will involve a training session and within-subject repeated measures. Stimuli will be randomized.

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 (Participant, Investigator)

盲法说明

Hearing aid processing settings are randomized and double blinded.

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
否

入选标准

  • •Adults (18-99 years) with ≥3 months hearing aid experience
  • •binaural, symmetric, sensorineural N2 (mild) to N5 (severe) hearing loss
  • •fluent in English

排除标准

  • •children/teenagers
  • •normal hearing or hearing loss exceeding N5 (severe) by 10 dB

研究组 & 干预措施

Participants with hearing loss.

Experimental

Participants with hearing loss.

干预措施: Investigational adaptive directional microphone strategy (Device)

Participants with hearing loss.

Experimental

Participants with hearing loss.

干预措施: Comparator omnidirectional microphone strategy (Device)

Participants with hearing loss.

Experimental

Participants with hearing loss.

干预措施: Comparator fixed directional microphone strategy (Device)

结局指标

主要结局

Speech Clarity

时间窗: Up to 6 hours over 3 2-hour sessions

The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "Please rate the clarity of speech". Speech clarity ratings will be measured on a 100-point continuous slider from worst to best (0-Very unclear, 25- Unclear, 50-Slightly clear, 75-Clear, 100-Very clear). Speech clarity ratings are expected to be impacted by how intelligible the speech is. Participants will rate and compare speech clarity between the investigational and comparator features.

Noise Annoyance

时间窗: Up to 6 hours over 3 2-hour sessions

The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "Please rate how annoying the noise is". Noise annoyance ratings will be measured on a 100-point continuous slider from worst to best (0- Extremely annoying, 25-Very annoying, 50-Moderately annoying, 75-Slightly annoying, 100-Not at all annoying). Noise annoyance ratings are expected to be impacted by how bothersome the background noise in the recordings is. Participants will rate and compare noise annoyance between the investigational and comparator features.

Spatialization

时间窗: Up to 6 hours over 3 2-hour sessions

The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "Please rate your confidence that the talker is in \[a location\]", with the local being either passenger of rear left. Spatialization ratings will be measured on a 100-point continuous slider from worst to best (0-I don't know where the talker is, 25-The talker might be to my \[location\], 50-The talker is probably to my \[location\], 75-The talker is to my \[location\], 100-The talker is definitely to my \[location\]). Spatialization ratings are expected to be impacted by how well the recordings preserve spatial perception. Participants will rate and compare spatialization between the investigational and comparator features.

Transition Annoyance

时间窗: Up to 6 hours over 3 2-hour sessions

The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "Please rate how annoying the transitions are". Transitions annoyance ratings will be measured on a 100-point continuous slider from worst to best (0-Extremely annoying, 25-Very annoying, 50-Moderately annoying, 75-Slightly annoying, 100-Not at all annoying). Transition annoyance ratings are expected to be influenced by presence of unexpected sounds or transitions that occur in different microphone modes and different listening situations. Participants will rate and compare transition annoyance between the investigational and comparator features.

Overall Impression

时间窗: Up to 6 hours over 3 2-hour sessions

The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "All things considered, please rate overall preferences". Overall preferences ratings will be measured on a 100-point continuous slider from worst to best (0-Bad, 25-Poor, 50-Fair, 75-Good, 100-Excellent). Overall impression ratings are expected to be impacted by participants' overall preferences for the different stimuli. Participants will rate and compare overall impression between the investigational and comparator features.

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 (1)

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