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.
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Phonological and orthographic processing - wording reading ability
Timeframe: 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 and orthographic processing - rapid automatized naming
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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).
Reading comprehension
Timeframe: 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
Timeframe: 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).