跳至主要内容
临床试验/NCT04363580
NCT04363580终止不适用

Creation of Auditory Processing Disorder Screening Tool in French

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2020年9月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
16
试验地点
1
主要终点
Sensitivity

研究概览

简要总结

The objective of the study is to validate a screening tool for auditory processing disorder in children of 7 to 13 years old. This screening tool was created based on literature and combines a questionnaire and a mini-battery of tests composed of verbal and nonverbal assessments.

详细描述

Hearing plays a vital role in the development of a child. Hearing is based on two main systems: the peripheral system and the central system. Peripheral hearing, which includes the outer, middle, and inner ear and the auditory nerve, can detect sound signals.

For its part, the central system, which is composed of auditory structures from the auditory nerve to the brain, makes it possible to process these sound signals and to analyze them. Peripheral hearing damage will result in deafness while a problem in the central auditory system will be called auditory processing disorder. Peripheral deafness can be detected from birth through neonatal screening for deafness. The symptoms of an auditory processing disorder can easily be confused with those caused by attention deficit disorder with or without hyperactivity and a specific language disorder. Auditory processing disorder is often unknown in the medical and educational worlds, and children are referred late for consultation. In addition, the lack of French screening tests for auditory processing disorder and the long waiting lists for specialized consultations help to delay diagnosis and hinder early intervention. Auditory processing disorder affects about 2 to 3% of school-aged children.

The objective of the study is to validate a screening tool for auditory processing disorder in children of 7 to 13 years old. This screening tool was created based on literature and combines a questionnaire and a mini-battery of tests composed of verbal and nonverbal assessments.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
7 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child aged 7 to 13 on the day of enrollment.
  • Child referred for assessment of central auditory skills, who did not have an auditory processing disorder -type assessment before.
  • Hearing thresholds at both ears between 0 decibels Hearing Level (dB HL) and 15 dB HL at 250, 500, 1000, 2000, 4000 and 8000 Hz. Absence of auditory neuropathy.
  • Child affiliated to a social security scheme.
  • Holders of parental authority who do not oppose the patient's participation in research.

排除标准

  • Known neurological disorder (epilepsy, cranial trauma, etc.).
  • Non medicated attention deficit since the presence of such a deficit can affect the child's performance during the auditory processing disorder assessment.
  • Intellectual disability since impairment of cognitive skills may also explain poor test performance (IQ <80).

研究组 & 干预措施

Patients

Children consulting for an assessment of central auditory skills

干预措施: Auditory processing disorder screening tool (Other)

结局指标

主要结局

Sensitivity

时间窗: 2 years

Comparison of the results of the auditory processing disorder screening tool with those obtained at the auditory processing disorder reference diagnostic battery. Sensitivity: Number of true positives / Number of true positives + Number of false negatives For the screening tool questionnaire, a score of 1 is given for each item for which parents or teachers believe that the child has a problem. A score of more than 50% on the questionnaire (or sub-section) suggests that the child is at risk of having an auditory processing disorder. The child would also be at risk when he fails at least one hearing test of the tool.

Specificity

时间窗: 2 years

Comparison of the results of the auditory processing disorder screening tool with those obtained at the auditory processing disorder reference diagnostic battery. Specificity: Number of true negatives / Number of true negatives + Number of false positives For the screening tool questionnaire, a score of 1 is given for each item for which parents or teachers believe that the child has a problem. A score of more than 50% on the questionnaire (or sub-section) suggests that the child is at risk of having an auditory processing disorder. The child would also be at risk when he fails at least one hearing test of the tool.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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