NCT07247253

Intervention Efficacy of ALD for Children With Dyslexia

Intervention Efficacy of Assistive Listening Devices for Chinese Children With Dyslexia - a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Education University of Hong Kong · Academic / Other
• Sex: All
• Age: 7 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Dyslexia

Interventions

Type	Name	Description
DEVICE	Use of a real assistive listening device (FM system) in class.	The Real ALD arm used the real FM system in class.
DEVICE	Use of a Sham assistive listening device (FM system)	Use the Sham FM system in class for one year.

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-10-31
• Completion: 2018-10-31
• First posted: 2025-11-25
• Last updated: 2025-12-01

Locations

1 site across 1 country: Hong Kong