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临床试验/NCT06256081
NCT06256081已完成不适用

Testing the Hear Glue Ear Software Application on Patients With Glue Ear

Dr. Tamsin Brown2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年2月1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
入组人数
60
试验地点
2
主要终点
acceptability of the Hear Glue Ear application to children with glue ear and their families

研究概览

简要总结

To assess whether children with glue ear ( and some normal hearing controls) and their families find the Hear Glue Ear application acceptable and easy to use. Whether the hearing screening section on the app is comparable to the hearing test data obtained from formal audiology hearing tests.

详细描述

The Hear Glue Ear application aims to provide up-to-date information for families as well as audiobooks, songs and games for children with hearing loss secondary to glue ear, to be able to aid with their developmental skills (particularly speech, language, auditory processing, auditory memory and listening skills) during the period of time when they have glue ear.

Outcome measures include acceptability of the application by the family (provided by questionnaires to the child and an adult parent/ carer), usability of the app (a member of the research team will observe the child using the app and how much difficulty they have such as how many times the researcher has to help/ intervene) and comparison of the hearing screen on the app with formal audiology hearing test result.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

盲法说明

Single arm study of children trialling an app

入排标准

年龄范围
2 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • aged 2-8 years old
  • had a formal hearing test at Cambridge audiology clinic and has a diagnosis of gluem ear worse than 25dB at more than 1 frequency or nornmal hearing diagnosed where 20dB or better is recorded at 0.5, 1, 2, 4 KHz

排除标准

  • permanent hearing loss
  • English not a dominant language (since the app is written in English)

结局指标

主要结局

acceptability of the Hear Glue Ear application to children with glue ear and their families

时间窗: Observing the child looking at the app for he first time and following up with the family after 1 week from baseline regarding whether they used it at home

Questionnaire: Whether children like the Hear Glue ear app and find it useful

次要结局

  • Ease of use of the Hear Glue ear application(1 hour. one appointmnet where the researcher observes the child accessing the app)
  • does the hearing screen on the Hear Glue Ear application compare to hearing test results from formal audiology testing.(1 hour maximum. one appointmnet where the researcher observes the child accessing the app)

研究者

发起方
Dr. Tamsin Brown
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Tamsin Brown

Principal investigator

Cambridgeshire Community Services NHS Trust

研究点 (2)

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