Intervention Efficacy of ALD for Children With Dyslexia

Education University of Hong Kong

Status: Completed

Conditions: Dyslexia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07247253

14150431

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 7 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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71 participants in 2 patient groups

Real ALD

Experimental group

Description:

Real ALD arm used real ALD (assistive listening device)

Treatment:

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

Sham ALD

Sham Comparator group

Description:

Sham ALD arm uses sham ALD (assistive listening device)

Treatment:

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