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临床试验/NCT02353091
NCT02353091已完成不适用

Effects of Remote Microphone Hearing Aids on Classroom Listening, Spatial Listening, and Attention in School-Aged Children With Auditory Processing Disorder

University College, London0 个研究点目标入组 26 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
主要终点
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Low-cue Speech Reception Threshold Condition

研究概览

简要总结

Auditory Processing Disorder (APD) is a disorder where the functions of the ear are normal, but the person has difficulty identifying or discriminating sounds and experiences listening difficulties in noise. Remote Microphone Hearing Aids (RMHAs) are wireless listening devices that pick up the speaker's voice and transmit it to a receiver in the listener's ear. In this way, the negative effects of ambient noise, distance from speaker and reverberation are reduced.

The research questions are whether RMHAs improve classroom listening, listening in noise performance, listening in spatialised noise and auditory attention, in children with APD. We hypothesize that RMHA use will lead to improved classroom listening and improved speech-in-noise skills after 6 months of RMHA use. Additionally, we hypothesise that listening in spatialised noise and attention skills will remain unchanged following the intervention period.

Twenty-six (26) children aged 7-12 with a diagnosis of an APD from the Great Ormond Street Hospital Audiology clinic were included in the study.

详细描述

Auditory Processing Disorder (APD) is a disorder where the functions of the ear (outer, middle, inner) are normal but the person has difficulty identifying or discriminating sounds (1). For children with APD it is particularly difficult to hear when the listening conditions are not ideal. For example, when there is background noise it becomes really challenging to focus on the speaker. Two other factors that influence their hearing ability are reverberation and the distance from the speaker (2). Some symptoms reported for APD are listening difficulties in background noise, attention and memory problems, and distractibility (3,4). Children with APD have worse skills in speech perception in noise compared to typically developing children (5,6) and have also have poorer sustained auditory attention compared to children suspected of APD (7).

Remote Microphone Hearing Aids (RMHAs) are a management approach recommended for children with APD. These are wireless listening devices that pick up the speaker's voice and transmit it to a receiver in the listener's ear. The use of this system helps improve the signal-to-noise ratio for children and bypasses the negative effects of background noise and reverberation in the classroom (2,8,9). There have not been many studies, though. That looked into the effects of RMHA on children with APD. Previous research suggests that children with APD after a prolonged use of RMHAs benefit from improved speech perception which is possibly linked to an enhanced auditory system (9). Adding to that, children with APD have shown improved speech in noise perception when using the RMHA, hence emphasizing the advantages of the device in discriminating speech in background noise (9,10).

Sustained attention and the ability of children with APD to listen in spatialised noise after RMHA use has been examined by one study (10). It did not show improvement (unaided) in any of the two tests. However, this was a non-randomised trial that did not use a control group. As the central point of this study will be the use of the RMHA by children with APD for 6 months, it is expected that the findings could add valuable information on the subject.

Aim and hypotheses The aim of the study is to examine the effect of a 6-month RMHA use on self-reported listening in the classroom, speech perception in noise, speech perception in spatialised noise and on attention skills.

Hypotheses:

研究设计

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

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Listening in Spatialised Noise - Sentences Test (LiSN-S) - Low-cue Speech Reception Threshold Condition

时间窗: Baseline to 6 months

Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.

Listening in Spatialised Noise - Sentences Test (LiSN-S) - High-cue Speech Reception Threshold Condition

时间窗: 6 months

Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.

Listening in Spatialised Noise - Sentences Test (LiSN-S) - Total Advantage Condition

时间窗: Baseline to 6 months

Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.

Listening Inventory For Education Revised (LIFE-R) - Total Score

时间窗: Baseline to 6 months

Children questionnaire measured in raw scores. This is the total score of 9 questions on a likert scale from 0 to 5. Thus, this is the summed score. Therefore, minimum value 0, maximum value 45. Higher scores mean better outcome.

Listening in Spatialised Noise - Sentences Test (LiSN-S) - Talker Advantage Condition

时间窗: Baseline to 6 months

Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.

Listening in Spatialised Noise - Sentences Test (LiSN-S) - Spatial Advantage Condition

时间窗: Baseline to 6 months

Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.

次要结局

  • Test of Everyday Attention for Children TEACh - Selective Visual Attention Subscale(Baseline to 6 months)
  • Test of Everyday Attention for Children TEACh - Sustained Auditory Attention Subscale(Baseline to 6 months)
  • Test of Everyday Attention for Children TEACh - Divided Auditory Attention Subscale(Baseline to 6 months)
  • Test of Everyday Attention for Children TEACh - Divided Auditory-Visual Attention Subscale(Baseline to 6 months)

研究者

申办方类型
Other
责任方
Sponsor

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