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临床试验/NCT05465564
NCT05465564进行中(未招募)不适用

My Hearing Experience - a Study About the Effect of Personality and Lifestyle on Everyday Hearing

WSAUD A/S1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
WSAUD A/S
入组人数
40
试验地点
1
主要终点
overall hearing aid satisfaction

研究概览

简要总结

The primary purpose of this study is to investigate how personality, motivation & auditory lifestyle relate to hearing aid satisfaction & acceptance for first-time hearing aid users. As such, first-time hearing aid users will be followed via an app for a period of six months. They will answer baseline questionnaires about personality, lifestyle and hearing aid expectations before the first fit. After the hearing aid fitting, they will be prompted by the app to answer questionnaires about their hearing aid experience at weeks 2, 4, 8, 12, 16, 20 and 24.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-85 years of age
  • Sensorineural hearing loss within the hearing aid's fitting range
  • Fluency in local language
  • First-time hearing aid user
  • Experienced smartphone and app user
  • Must sign the informed consent

排除标准

  • Severe cognitive impairment that would preclude the ability to perform the necessary tasks (as judged by the HCP)
  • Inability for the TPs to travel to the clinic during the study period
  • Complex hearing disorders such as Ménière's

结局指标

主要结局

overall hearing aid satisfaction

时间窗: 6 months

minimum: 1, maximum: 10 ; the higher value indicates a better outcome

IOI-HA

时间窗: 6 months

minimum: 7, maximum: 35; the higher value indicates a better outcome

hearing aid satisfaction (Hearing-Related Lifestyle scale)

时间窗: 6 months

minimum: 1, maximum: 5; the higher value indicates a better outcome

次要结局

未报告次要终点

研究者

发起方
WSAUD A/S
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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