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临床试验/NCT05854719
NCT05854719已完成不适用

Eyes On Lips? - Identifying Optimal Gaze Patterns and Support Obtained From Facial Expressions in Enhancing Speechreading Skills in Children With and Without Impaired Hearing

University of Oulu1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2023年5月12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
140
试验地点
1
主要终点
Level of performance in emotions (facial expressions) + sentence-level speeachreading task

研究概览

简要总结

The goal of this clinical trial is to find out the role of background factors and gaze use in children's speechreading performance.

The main questions it aims to answer are:

  • Which background factors and eye gaze patterns are associated with the best speechreading results in hearing children and those with hearing impairment/loss?
  • Are children's gaze patterns and facial expression discrimination associated with interpretation of emotional contents of verbal messages in speechreading?
  • What is the efficacy of intervention that is based on the use of a speechreading application to be developed?

Participants will be

  • tested with linguistic and cognitive tests and tasks
  • tested with a speechreading test and tasks with or without simultaneous eye-tracking
  • about half of the participants with hearing impairment/loss will train speechreading with an application

Researchers will compare the different age groups and the results of hearing children to those of children with impaired hearing to see if there are differences.

详细描述

  1. Aim The objectives of this project are to 1) gain information about speechreading abilities in Finnish of children without and with hearing impairment, 2) obtain information about the association between gaze behaviour and speechreading accuracy, 3) develop a test for speechreading for Finnish-speaking children, 4) find out whether emotion discrimination (discrimination of facial expressions) helps children with impairment in speechreading, 5) find out whether speechreading can effectively be trained with a smart device application, and 6) explore and train artificial intelligence algorithms further with the help of data on children's use of gaze and speechreading skills (this part does not belong to the clinical trial part of the study).
  2. Study design Controlled, clinical trial. Study arms: 1) hearing children serving as controls 2) children with impaired hearing participating in speechreading training, 3) children with impaired hearing serving as controls

Altogether 50 children (a part of them with impaired hearing) will be tested remotely (via Zoom application), and about 90 children on site (as eye-tracking is used in data collection from them; a part of the children with impaired hearing).

Caregivers will be requested to fill out a background form by using an on-line survey platform REDCap having a high data protection capability. Caregivers will give information about their child's hearing ability/level based on the most recent audiogram, overall health (e.g., possible medical diagnoses, vision) and development. Caregivers' profession and educational level will also be surveyed.

Child outcomes:

Children will be tested with linguistic, cognitive and social cognitive tests and tasks and 90 children also with eye-tracking.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
8 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Normally hearing children:
  • age 8-11 years
  • being born full-term (on
  • gestational week or later)
  • Finnish speaking (Finnish is the language the child's family uses at home, the child goes to a school where Finnish is used as the language of instruction)
  • normal hearing and vision
  • typically developing, mainstream education curriculum at school
  • for those tested remotely: computer available at home for remote testing
  • Children with hearing impairment/loss:
  • age 8-11 years
  • diagnosed bilateral hearing impairment
  • being born full-term (on
  • gestational week or later)
  • Finnish speaking (Finnish is the language the child's family uses at home, the child goes to a school where Finnish is used as the language of instruction)
  • normal vision
  • (mainly) typically developing
  • for those tested remotely: computer available at home for remote testing

排除标准

  • Normally hearing children: psychiatric and neurodevelopmental disorders, including ADHD (Attention Deficit and Hyperacitivity Disorder)
  • Children with hearing impairment/loss: psychiatric and neurodevelopmental disorders (excluding ADHD if medication helps the child to concentrate well during testing)

结局指标

主要结局

Level of performance in emotions (facial expressions) + sentence-level speeachreading task

时间窗: Two months

Score obtained (percent correct, min 0, max 100, higher score indicates better result)

Level of speechreading skill

时间窗: Two months

Score obtained in Children's speechreading test (percent correct, min 0, max 100, higher score indicates better result)

次要结局

  • Eye gaze use(Two months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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