DyslexiaNCT07247253

Intervention Efficacy of ALD for Children With Dyslexia

A study testing Use of a real assistive listening device (FM system) in class. in people with Dyslexia, run by Education University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 7 to 11 years
Conditions the study is for: Dyslexia
What is being tested?: Use of a real assistive listening device (FM system) in class.
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 71 participants
Where: 1 siteHong Kong
Study dates: 1 Jun 2017to 31 Oct 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

The Education University of Hong Kong
Hong Kong

Other trials in Hong Kong

About this study

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

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
Being tested: Use of a real assistive listening device (FM system) in class., Use of a Sham assistive listening device (FM system)
Keywords: Dyslexia, Assistive listening devices, RCT, Chinese
Medical subject headings: Dyslexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT07247253
Study group	Role	What they receive
Real ALD	Experimental	Real ALD arm used real ALD (assistive listening device) Receives: 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) Receives: Device: Use of a Sham assistive listening device (FM system)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Tone perception ability was assessed with the Hong Kong Cantonese Tone Identification Test (CANTIT)17.
- The test consisted of a computerized picture-pointing task. After the target word has been presented auditorily, the subject must select an answer among four choices.
Measured: 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
Speech-perception-in-noise ability was assessed with the Cantonese Hearing in Noise Test (CHINT)18.
- The test was software-driven and the assessor judged and input the subject's correct or incorrect response for each trial. During the test, speech spectral noise was presented at 70 dB SPL at zero degree azimuth. The presentation level of the target sentence was presented in an adaptive manner (i.e., the presentation of the next target sentence would be decreased by 2 dB for a correct repetition of the current target sentence and vice versa).
Measured: 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
Language ability was assessed with the Hong Kong Cantonese Oral Language Assessment Scale (HKCOLAS).
- HKCOLAS consisted of six subscales: Hong Kong Cantonese grammar, textual comprehension, word definition, lexical-semantic relations, narrative, and expressive nominal vocabulary.
- The score of each subscale ranges from 1 to 19. The higher the score, the better the performance.
Measured: 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
Articulation was assessed with the Hong Kong Cantonese Articulation test (HKCAT)20.
- HKCAT consisted of four subscales: consonants, vowels, codas, and tone. The subjects were required to name some pictures.
Measured: 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
Phonological awareness was assessed with a combined test of phoneme rhyme production and phoneme onset deletion.
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201731 Oct 2018

First posted25 Nov 2025
Study start1 Jun 2017
Primary completion31 Oct 2018
Study completion31 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DyslexiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07247253
Sponsor's protocol ID: 14150431
Status last verified: Nov 2025
First submitted: 15 Jul 2025
Last updated: 1 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia
Dyslexia, Reading Disability
Recruiting
Personalization of Visual Characters and Text-to-Speech (TTS) to Support Learning in Students With Reading Difficulties
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Recruiting
Dynamic Assessment of the Risk for Language and Reading Disorders in Monolingual and Multilingual Children
Developmental Dyslexia, Developmental Language Disorder
Active, not recruiting
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Active, not recruiting
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All Dyslexia trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intervention Efficacy of Assistive Listening Devices for Chinese Children With Dyslexia - a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07247253
Acronym / sponsor ID: 14150431
Conditions: Dyslexia
Keywords: Dyslexia, Assistive listening devices, RCT, Chinese
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Education University of Hong KongUniversity, hospital or other
Collaborators: Health and Medical Research Fund
Study start: 1 Jun 2017 (actual)
Primary completion: 31 Oct 2018 (actual)
Study completion: 31 Oct 2018 (actual)
First posted: 25 Nov 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Real ALD	Experimental	Device: Use of a real assistive listening device (FM system) in class.Real ALD arm used real ALD (assistive listening device)
Sham ALD	Sham comparator	Device: Use of a Sham assistive listening device (FM system)Sham ALD arm uses sham ALD (assistive listening device)

Who may qualify

Ages: 7 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

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

Primary outcome

Phonological and orthographic processing - wording reading ability
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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

5 secondary outcomes

Tone perception ability
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
Individual participant dataSharing planned: No

Related trials for Dyslexia

Enrolling by invitation
Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia
Dyslexia, Reading Disability
Recruiting
Personalization of Visual Characters and Text-to-Speech (TTS) to Support Learning in Students With Reading Difficulties
Developmental Dyslexia, Reading Problem
Recruiting
Dynamic Assessment of the Risk for Language and Reading Disorders in Monolingual and Multilingual Children
Developmental Dyslexia, Developmental Language Disorder
Active, not recruiting
Promoting Caregiver Implementation of an Effective Early Learning Intervention
Developmental Language Disorder, Reading; Difficult
Active, not recruiting
Pai.ACT: AI-Driven ACT Chatbot for Mental Health Triage and Service Evaluation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Use of a real assistive listening device (FM system) in class. in people with Dyslexia, run by Education University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phonological and orthographic processing - wording reading ability (time frame: 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).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07247253.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.