Intervention Efficacy of Assistive Listening Devices for Chinese Children With Dyslexia - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Phonological and orthographic processing - wording reading ability
研究概览
简要总结
This double-blind, randomized controlled crossover trial aimed to evaluate the efficacy of providing assistive listening devices (ALDs) in improving specific abilities among Chinese children diagnosed with dyslexia. The primary purpose was to determine whether using ALDs in the classroom setting over the course of one academic year (10 months) leads to significant improvements in literacy abilities compared to using sham (placebo) devices. The study specifically sought to answer the question: Does intervention with real ALDs, as opposed to sham devices, result in superior gains in literacy skills, measured by the change from baseline to 10 months post-intervention initiation? Furthermore, the trial investigated potential treatment benefits on several secondary outcomes, including the neural representation of speech (specifically the consistency of auditory brainstem response to speech sounds), auditory processing abilities, speech and language abilities, phonological awareness, and teachers' perceptions of the children's listening performance in class. The core objective was thus to assess the therapeutic impact of ALDs on literacy development and related auditory and neural functions in this pediatric dyslexic population within their educational environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged seven to eleven years;
- •diagnosed with dyslexia;
- •registered normal IQs (scores > 85);
- •displayed normal hearing, with air-conduction thresholds of smaller than or at 25 dB hearing level (HL) for pure tones at octave intervals from 250 Hz to 8000 Hz, with an air-bone gap of < 10 dB for pure tones ranging from 500 Hz to 4000 Hz;
- •have not reported current or prior neurological disorders;
- •have obtained written informed consent;
- •committed to completing the entire study; and
- •Chinese who speak Cantonese as the first language.
排除标准
- •with known neurological disorders
- •with hearing loss
- •have not provided written informed consent
- •non native Cantonese speaker
结局指标
主要结局
Phonological and orthographic processing - wording reading ability
时间窗: At enrollment, 10-months after the use of first intervention (real or sham FM system), and 10-months after the use of intervention (sham or real FM system).
Word reading ability was assessed by counting the number of Chinese character being read correctly in a passage in one minute.
Phonological and orthographic processing - rapid automatized naming
时间窗: At enrollment, 10-months after the use of first intervention (real or sham FM system), and 10-months after the use of intervention (sham or real FM system).
A page of randomized letters was presented. The child was required to read the letters row by row as quickly as possible. The number of correctly named letters was counted in one minute.
Orthographic knowledge
时间窗: At enrollment, 10-months after the use of first intervention (real or sham FM system), and 10-months after the use of intervention (sham or real FM system).
Orthographic knowledge was assessed by distinguishing real words from nonwords in 20 trials. Percent correct was marked.
Grammar knowledge
时间窗: At enrollment, 10-months after the use of first intervention (real or sham FM system), and 10-months after the use of intervention (sham or real FM system).
Grammar knowledge was measured by a sentence reconstruction task. There were 20 items, and the percent correct was marked.
Morphological awareness
时间窗: At enrollment, 10-months after the use of first intervention (real or sham FM system), and 10-months after the use of intervention (sham or real FM system).
Morphological awareness was assessed by a homophone identification task. The percent correct on 20 test items was marked.
Reading comprehension
时间窗: At enrollment, 10-months after the use of first intervention (real or sham FM system), and 10-months after the use of intervention (sham or real FM system).
A short passage was presented to the kid. The kid was required to answer ten questions based on the understanding of the passage. The percent correct was marked.
Consistency of ABR to sound
时间窗: At enrollment, 10-months after the use of first intervention (real or sham FM system), and 10-months after the use of intervention (sham or real FM system).
Consistency of ABR to sound was assessed with this test: \- An electrophysiological recording protocol that has been employed reliably in previous studies was adopted.16 In brief, the stimuli consisted of 170 ms /ba/, /da/, and /ga/ syllables synthesized with a 50 ms formant transition. In this transition, the first, second, and third formants were dynamic; the fundamental frequency, fourth formant, and fifth formant were stable throughout the process. The stimuli were presented at 80 dB SPL to the right ear monaurally via insert earphones. The polarities of the stimuli alternate at a rate of 4.35 Hz. ABR was captured using a vertical Ag-AgCI electrode montage (Cz active, forehead ground, ipsilateral earlobe reference) in combination with the SmartEP (Intelligence Hearing Systems). A bandpass filter of 70 Hz to 2000 Hz was employed, and a total of 6,000 artifact-free responses (3,000 for each polarity) were obtained for each of the three sounds. Responses from even-numbered events thro
次要结局
- Speech-perception-in-noise ability(At enrollment, 10-months after the use of first intervention (real or sham FM system), and 10-months after the use of intervention (sham or real FM system).)
- Oral language ability(At enrollment, 10-months after the use of first intervention (real or sham FM system), and 10-months after the use of intervention (sham or real FM system).)
- Articulation(At enrollment, 10-months after the use of first intervention (real or sham FM system), and 10-months after the use of intervention (sham or real FM system).)
- Phonological awareness(At enrollment, 10-months after the use of first intervention (real or sham FM system), and 10-months after the use of intervention (sham or real FM system).)
- Tone perception ability(At enrollment, 10-months after the use of first intervention (real or sham FM system), and 10-months after the use of intervention (sham or real FM system).)
- Speech-perception-in-noise ability(At enrollment, 10-months after the use of first intervention (real or sham FM system), and 10-months after the use of intervention (sham or real FM system).)
- Oral language ability(At enrollment, 10-months after the use of first intervention (real or sham FM system), and 10-months after the use of intervention (sham or real FM system).)
- Articulation(At enrollment, 10-months after the use of first intervention (real or sham FM system), and 10-months after the use of intervention (sham or real FM system).)
- Phonological awareness(At enrollment, 10-months after the use of first intervention (real or sham FM system), and 10-months after the use of intervention (sham or real FM system).)
研究者
KAM Chi Shan Anna
Associate Professor
Education University of Hong Kong