NCT07297524

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress54%
Dec 2025Aug 2026

First Submitted

Initial submission to the registry

December 9, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

December 22, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

December 9, 2025

Last Update Submit

December 9, 2025

Conditions

Keywords

Multimodal Acoustic TherapyCochlear ImplantPediatric Cochlear Implant UsersAdolescent Cochlear Implant UsersAuditory RehabilitationMobile ApplicationDigital Health Intervention

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (7)

  • Music-Related Quality of Life (MuRQoL)

    12 weeks

  • Parents' Evaluation of Aural/Oral Performance of Children (PEACH)

    12 weeks

  • Quality of Life - Cochlear Implants (Parent-Proxy Report)

    12 weeks

  • Emotional Prosody Perception Test (EPP)

    12 weeks

  • Monosyllabic Word Test

    4 weeks

  • +2 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

Device: Auditory rehabilitation application Application: Wowfit

Device: Mobile Auditory Rehabilitation

Interventions

Mobile Application for Auditory Rehabilitation

Intervention

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 9, 2025

First Posted

December 22, 2025

Study Start

December 22, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations