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临床试验/NCT05125601
NCT05125601已完成不适用

Hearing Quality of Life of Children With Hearing Aids: Study Based on the PEACH Questionnaire

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2021年12月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
1
主要终点
Hearing quality of life

研究概览

简要总结

There are few or no questionnaires in French on the hearing quality of life of children with hearing aids.

The objectives of the study are to measure the hearing quality of life of children with hearing aid and / or cochlear implants and to compare the hearing quality of life according to the type of hearing aid (hearing aid and / or cochlear implant).

详细描述

There are few or no questionnaires in French on the hearing quality of life of children with hearing aids.

The study will allow an evaluation of the quality of life benefit of hearing rehabilitation at different ages and with varying levels of deafness.

The translated questionnaire for the study will be given to the parents of the child after a sure diagnosis of the child's degree of deafness and at least 1 month of hearing aids. The translated is proposed by Necker Hospital Pediatric ENT department.

The objectives of the study are to measure the hearing quality of life of children with hearing aid and / or cochlear implants and to compare the hearing quality of life according to the type of hearing aid (hearing aid and / or cochlear implant).

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
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Minors aged 2 to 10 years (inclusive)
  • Patients followed in consultation at Necker Hospital in the Pediatric ENT department
  • With a slight to deep bilateral deafness
  • Auditory experience with hearing aid and / or cochlear implant bilateral for more than 1 month
  • holders of parental authority not opposed to participation in the study

排除标准

  • Non-wearing of hearing aid and / or implant over the last month
  • malfunction of hearing aids and / or implant
  • Non-understanding of the French language by parents

结局指标

主要结局

Hearing quality of life

时间窗: Day 0

Score at the Peach questionnaire: qualitative assessment of the perception with the equipment in various modalities of everyday life. The Peach questionnaire is composed of 13 questions with the possibility of setting a score between 0 (never) and 4 (always). Each questionnaire gives an average of the embarrassment of the children in the silence and in the noise. The results will give the opportunity to change the settings, evaluate the quality of the hearing aid and the change them if it is necessary.

次要结局

  • Difference of score to the Peach questionnaire according to the type of hearing aids(Day 0)
  • Difference of score to the Peach questionnaire according to the type of deafness(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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