About this trial
This exploratory, single-center, single-arm study investigates the impact of a 12-week Multimodal Acoustic Therapy (MAT) intervention followed by a 12-week follow-up period on both objective and subjective auditory perception in pediatric cochlear implant users.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals with cochlear implants
Korean patients aged 10 to 19 years
Capable of using a smartphone
Scored ≤80% on MCI pre-assessment
Disqualifiers
Has systemic medical conditions (e.g., cancer, stroke) that limit daily functioning
Has intellectual disability, congenital malformation, or other neurological disorders affecting language or cognitive abilities
Has diagnosed emotional disorders such as depression or anxiety
Primarily uses sign language for daily communication
Trial design
Single group
Treatments tested in this trial
Mobile Auditory Rehabilitation
DeviceMobile Application for Auditory Rehabilitation
Treatment groups
Trial outcomes
Primary outcomes
Melody Contour Identification (MCI)
Participants complete a melody contour identification task in which they listen to brief melodic sequences and select the contour pattern (e.g., rising, falling, flat). Performance is quantified as the percentage of correctly identified contours (% correct). Higher scores indicate better melody contour perception.
Secondary outcomes
Music-Related Quality of Life (MuRQoL)
Each item is rated on a 1-5 Likert scale, and domain scores may be converted to a normalized 0-100 scale. Higher scores indicate better music-related quality of life.
Parents' Evaluation of Aural/Oral Performance of Children (PEACH)
Auditory performance in everyday listening situations will be evaluated using the Parents' Evaluation of Aural/Oral Performance of Children (PEACH) questionnaire. Parents rate their child's functional auditory behaviors across quiet and noisy environments. Scores are converted to a percentage (0-100%), with higher scores indicating better auditory performance. The PEACH is a parent-proxy assessment tool, consistent with its standard scoring procedure.
Quality of Life - Cochlear Implants (Parent-Proxy Report)
Quality of life specific to pediatric cochlear implant users will be assessed using the Quality of Life - Cochlear Implants (CI-QOL) questionnaire. This is a parent-proxy reported measure, in which parents rate their child's auditory-related daily functioning, communication abilities, social participation, and emotional well-being. Scores range from 0 to 100, with higher scores indicating better quality of life.
Emotional Prosody Perception Test (EPP)
Performance will be reported as the percentage. Higher percentages indicate better emotional prosody perception.
Sponsors and contacts
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Seoul National University Hospital
Lead sponsor
BELL Therapeutics Inc.
Collaborator
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