跳至主要内容
临床试验/NCT07116135
NCT07116135招募中不适用

Speech Understanding and Listening Effort Benefits of Infinio Sphere

Sonova AG2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年2月5日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
Sonova AG
入组人数
30
试验地点
2
主要终点
Speech intelligibility as assessed by the Coordinate Response Measure (CRM) Task

研究概览

简要总结

The goal of this clinical study is to investigate the benefits of hearing instrument use in adults with hearing loss. The main questions it aims to answer are:

Does hearing instrument use improve speech understanding and listening effort amount people with hearing loss? Researchers will compare varying models of hearing instruments to see how speech understanding and listening effort are impacted.

Participants will be asked to wearing varying hearing instruments and participate in lab-based activities to evaluate their speech understanding, listening effort, and subjective preference.

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

The participant will not know which condition they are being tested in, but all participants will be given the same intervention and not blinded to the intervention.

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult 18-95 years
  • N3 or N4 hearing loss
  • Experienced hearing aid user
  • English fluency
  • Cognitively able to complete complex listening tasks

排除标准

  • Outside of specified age range
  • Vulnerable populations
  • Hearing within normal limits or otherwise not appropriate for hearing instruments under study
  • Inability to read, write, or speak English
  • Inability to complete complex listening tasks

结局指标

主要结局

Speech intelligibility as assessed by the Coordinate Response Measure (CRM) Task

时间窗: Data is collected during the second lab visit for each participant, approximately 2 weeks after study enrollment. The duration of the study visit including testing is approximately 2.5 hours.

During the CRM task (Bolia et al., 2000), participants are presented with a phrase detailing the following identifiers: target, color, and digit. They must listen for a target name and respond with the corresponding color and digit. Speech intelligibility performance is assessed based on accuracy, or percent correct across all trials conducted in a given condition.

次要结局

  • Listening Effort as assessed by the Adaptive Categorical Listening Effort Scaling (ACALES)(Data is collected during the second lab visit for each participant, approximately 2 weeks after study enrollment. The duration of the study visit including testing is approximately 2.5 hours.)

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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