CRESCENDO: ChildREn's muSiC ENhancement in Cochlear Implant Users

December 9, 2025 updated by: Sang-Yeon Lee, Seoul National University Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • Seoul
      • Seoul, Seoul, South Korea, 03080
        • Seoul National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Device: Auditory rehabilitation application Application: Wowfit
Device: Mobile Auditory Rehabilitation
Mobile Application for Auditory Rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Music-Related Quality of Life (MuRQoL)
Time Frame: 12 weeks

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.
12 weeks
Parents' Evaluation of Aural/Oral Performance of Children (PEACH)
Time Frame: 12 weeks

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.
12 weeks
Quality of Life - Cochlear Implants (Parent-Proxy Report)
Time Frame: 12 weeks

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.
12 weeks
Emotional Prosody Perception Test (EPP)
Time Frame: 12 weeks
Performance will be reported as the percentage. Higher percentages indicate better emotional prosody perception.
12 weeks
Monosyllabic Word Test
Time Frame: 4 weeks

Performance will be reported as the percentage of correctly identified words (% correct).

Higher percentages indicate better auditory word recognition ability.
4 weeks
Sentence Test in Quiet
Time Frame: 4 weeks

Performance will be reported as the percentage of correctly repeated sentences (% correct).

Higher percentages indicate better speech recognition ability.
4 weeks
Speech test in Noise
Time Frame: 4 weeks

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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

BELL Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 22, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

December 9, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2404-090-1531

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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