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NCT Number: NCT07297524

CRESCENDO: ChildREn's muSiC ENhancement in 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.

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Key information

Conditions

Cochlear Implant Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

10 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile Auditory Rehabilitation

Device

Mobile Application for Auditory Rehabilitation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Emotional Prosody Perception Test (EPP)

    Time frame: 12 weeks

    Performance will be reported as the percentage. Higher percentages indicate better emotional prosody perception.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • BELL Therapeutics Inc.

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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