An interventional study of Use of a real assistive listening device (FM system) in class. and Use of a Sham assistive listening device (FM system) in Dyslexia, sponsored by Education University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 7 Years to 11 Years. Per ClinicalTrials.gov, last updated 2025-12-01.
Sponsored by Education University of Hong Kong · Not applicable, Interventional, and Treatment
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.
127 studies on the registry are indexed under Dyslexia; 27 are open to participants now.
This study's enrollment of 71 is close to the median of 71 across 106 interventional studies indexed under Dyslexia.
Browse Dyslexia studies →Education University of Hong Kong is the lead sponsor of 35 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Real ALD arm used real ALD (assistive listening device)
Device: Use of a real assistive listening device (FM system) in class.
Sham ALD arm uses sham ALD (assistive listening device)
Device: Use of a Sham assistive listening device (FM system)
The Real ALD arm used the real FM system in class.
Use the Sham FM system in class for one year.
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.
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 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.
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
Orthographic knowledge was assessed by distinguishing real words from nonwords in 20 trials. Percent correct was marked.
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
Grammar knowledge was measured by a sentence reconstruction task. There were 20 items, and the percent correct was marked.
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
Morphological awareness was assessed by a homophone identification task. The percent correct on 20 test items was marked.
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).
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.
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
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
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).
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.
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
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).
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
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.
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
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.
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
Phonological awareness was assessed with a combined test of phoneme rhyme production and phoneme onset deletion.
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).
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2017 to primary completion in Oct 2018, 16 months.
Of 62 non-industry interventional studies with no phase under Dyslexia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 57. This study's 16 months is below that.
Counting every sponsor, half of 69 studies reached it within 24 months; a quarter within 9 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Education University of Hong Kong