Cochlear ImplantNCT07297524
CRESCENDO: ChildREn's muSiC ENhancement in Cochlear Implant Users
A study testing Mobile Auditory Rehabilitation in people with Cochlear Implant and Hearing Loss, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Cochlear Implant, Hearing Loss
- What is being tested?
- Mobile Auditory Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Dec 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Individuals with cochlear implants
- Korean patients aged 10 to 19 years
- Capable of using a smartphone
- Scored ≤80% on MCI pre-assessment
- Voluntarily agreed to participate in this study
Who cannot join
- 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
- Has undergone cochlear implant revision surgery
- Has prior experience with the investigational auditory rehabilitation application used in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 03080
Sang-Yeon Lee, MD, PhD, +82-2-2072-3550, maru4843@hanmail.net
About this study
Official title: A Single-Center, Single-Arm Exploratory Study to Evaluate the Impact of Multimodal Acoustic Therapy (MAT) on Objective and Subjective Auditory Perception During a 12-Week Intervention and a 12-Week Follow-Up in Pediatric and Adolescent Cochlear Implant Users
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.
Read the detailed description
Duration of study period (per participant): 24 weeks, including a 12-week intervention and a 12-week online follow-up.
Participants will use the Multimodal Acoustic Therapy (MAT) mobile application at home for 12 weeks to improve music and speech perception.
Participants will visit the site twice (baseline and post-intervention), while all other evaluations, including follow-up, will be conducted online.
The first on-site visit is mainly to on-board participants and to train them for accurate use of the intervention.
- Conditions
- Cochlear Implant, Hearing Loss
- Being tested
- Mobile Auditory Rehabilitation
- Keywords
- Multimodal Acoustic Therapy, Cochlear Implant, Pediatric Cochlear Implant Users, Adolescent Cochlear Implant Users, Auditory Rehabilitation, Mobile Application, Digital Health Intervention
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Auditory RehabilitationDevice
Mobile Application for Auditory Rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Device: Auditory rehabilitation application Application: Wowfit Receives: Device: Mobile Auditory Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (7)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Emotional Prosody Perception Test (EPP)
Performance will be reported as the percentage. Higher percentages indicate better emotional prosody perception.
Measured: 12 weeks
Monosyllabic Word Test
Performance will be reported as the percentage of correctly identified words (% correct).
Higher percentages indicate better auditory word recognition ability.
Measured: 4 weeks
Sentence Test in Quiet
Performance will be reported as the percentage of correctly repeated sentences (% correct).
Higher percentages indicate better speech recognition ability.
Measured: 4 weeks
Speech test in Noise
Sentence recognition will be assessed using standardized sentence materials presented in background noise at a +5 dB signal-to-noise ratio (SNR), where the noise level is higher relative to the speech signal.
Performance will be reported as the percentage of correctly repeated sentences (% correct).
Lower percentages are expected compared to quiet due to increased listening difficulty; higher percentages indicate better speech-in-noise perception ability.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start22 Dec 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BELL Therapeutics Inc.
- Responsible party
- Principal investigator, Sang-Yeon Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297524
- Sponsor's protocol ID
- H-2404-090-1531
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Single-Arm Exploratory Study to Evaluate the Impact of Multimodal Acoustic Therapy (MAT) on Objective and Subjective Auditory Perception During a 12-Week Intervention and a 12-Week Follow-Up in Pediatric and Adolescent Cochlear Implant Users
- ClinicalTrials.gov ID
- NCT07297524
- Acronym / sponsor ID
- H-2404-090-1531
- Conditions
- Cochlear Implant, Hearing Loss
- Keywords
- Multimodal Acoustic Therapy, Cochlear Implant, Pediatric Cochlear Implant Users, Adolescent Cochlear Implant Users, Auditory Rehabilitation, Mobile Application, Digital Health Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- BELL Therapeutics Inc.
- Study start
- 22 Dec 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 22 Dec 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.
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.
Detailed description
Duration of study period (per participant): 24 weeks, including a 12-week intervention and a 12-week online follow-up.
Participants will use the Multimodal Acoustic Therapy (MAT) mobile application at home for 12 weeks to improve music and speech perception.
Participants will visit the site twice (baseline and post-intervention), while all other evaluations, including follow-up, will be conducted online.
The first on-site visit is mainly to on-board participants and to train them for accurate use of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Mobile Auditory RehabilitationDevice: Auditory rehabilitation application Application: Wowfit |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Individuals with cochlear implants
- Korean patients aged 10 to 19 years
- Capable of using a smartphone
- Scored ≤80% on MCI pre-assessment
- Voluntarily agreed to participate in this study
Key exclusion criteria (6 listed)
- 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
- Has undergone cochlear implant revision surgery
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 |
|---|---|---|
| Mobile Auditory RehabilitationMobile Application for Auditory Rehabilitation | Device | Intervention |
Primary outcome
Melody Contour Identification (MCI)
Time frame: 12 weeks
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.
7 secondary outcomes
Music-Related Quality of Life (MuRQoL)
Time frame: 12 weeks
Parents' Evaluation of Aural/Oral Performance of Children (PEACH)
Time frame: 12 weeks
Quality of Life - Cochlear Implants (Parent-Proxy Report)
Time frame: 12 weeks
Emotional Prosody Perception Test (EPP)
Time frame: 12 weeks
Monosyllabic Word Test
Time frame: 4 weeks
Sentence Test in Quiet
Time frame: 4 weeks
Speech test in Noise
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Auditory Rehabilitation in people with Cochlear Implant and Hearing Loss, run by Seoul National University Hospital at 1 site in South Korea.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 22 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 South Korea. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melody Contour Identification (MCI) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2025.