Intervention Efficacy of ALD for Children With Dyslexia

NCT07247253 | Completed

• 1 other identifier: 14150431
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dyslexia; Assistive listening devices; RCT; Chinese

Outcome Measures

Primary Outcomes (7)

• Phonological and orthographic processing - wording reading ability

  Word reading ability was assessed by counting the number of Chinese character being read correctly in a passage in one minute.

  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

  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.

  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

  Orthographic knowledge was assessed by distinguishing real words from nonwords in 20 trials. Percent correct was marked.

  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

  Grammar knowledge was measured by a sentence reconstruction task. There were 20 items, and the percent correct was marked.

  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

  Morphological awareness was assessed by a homophone identification task. The percent correct on 20 test items was marked.

  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

  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.

  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

  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

  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).

Secondary Outcomes (5)

• 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).

Study Arms (2)

Real ALD

EXPERIMENTAL

Real ALD arm used real ALD (assistive listening device)

Device: Use of a real assistive listening device (FM system) in class.

Sham ALD

SHAM COMPARATOR

Sham ALD arm uses sham ALD (assistive listening device)

Device: Use of a Sham assistive listening device (FM system)

Interventions

Use of a real assistive listening device (FM system) in class. DEVICE

The Real ALD arm used the real FM system in class.

Real ALD

Use of a Sham assistive listening device (FM system) DEVICE

Use the Sham FM system in class for one year.

Sham ALD

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• with known neurological disorders
• with hearing loss
• have not provided written informed consent
• non native Cantonese speaker

Sponsors & Collaborators

• Education University of Hong Kong: lead
• Health and Medical Research Fund: collaborator

Study Sites (1)

The Education University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: November 25, 2025
• Study Start: June 1, 2017
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)