CRESCENDO: ChildREn's muSiC ENhancement in Cochlear Implant Users

NCT ID: NCT07297524

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-22

Study Completion Date

2026-08-31

Brief Summary

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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

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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

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Cochlear Implant Hearing Loss

Keywords

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Multimodal Acoustic Therapy Cochlear Implant Pediatric Cochlear Implant Users Adolescent Cochlear Implant Users Auditory Rehabilitation Mobile Application Digital Health Intervention

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Device: Auditory rehabilitation application Application: Wowfit

Group Type EXPERIMENTAL

Mobile Auditory Rehabilitation

Intervention Type DEVICE

Mobile Application for Auditory Rehabilitation

Interventions

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Mobile Auditory Rehabilitation

Mobile Application for Auditory Rehabilitation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BELL Therapeutics Inc.

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sang-Yeon Lee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Facility Contacts

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Sang-Yeon Lee, MD, PhD

Role: primary

Other Identifiers

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H-2404-090-1531

Identifier Type: -

Identifier Source: org_study_id