NCT06788184

Brief Summary

This study aimed to design and evaluate the effectiveness of a virtual reality-based restaurant simulation game to improve central auditory processing skills in children with bilateral cochlear implants. The study aims to improve auditory attention, working memory, and speech perception in noise. Children with bilateral cochlear implants between the ages of 10 and 18 will participate in this study, which combines traditional rehabilitation methods with a virtual reality game. The "Hearing in Noise Test" (HINT) assessment tools will be used. The game aims to present interactive scenarios that simulate auditory difficulties encountered in daily life and to improve auditory processing skills. The usability of the game will be tested in the pilot phase. This project aims to bring an innovative approach to rehabilitation programs and to contribute to the social integration of children with hearing loss while increasing social awareness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 12, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

January 12, 2025

Last Update Submit

July 27, 2025

Conditions

Keywords

Cochlear ImplantAuditory ProcessingVirtual RealityAuditory AttentionWorking Memory

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Speech Recognition in Noise Using the Hearing in Noise Test (HINT)

    The HINT test is an adaptable test for measuring sentence recognition threshold, which evaluates the status and efficiency of hearing in noise using sentences from daily life. The aim of the HINT test is to evaluate the auditory capacity of the individual in noisy environments.

    The outcome will be assessed at Baseline (Week 0) and Post-Intervention (Week 4), with improvements in scores reflecting better speech perception in noise.

Study Arms (2)

Control Group (Traditional Auditory Rehabilitation Only)

ACTIVE COMPARATOR

Participants in the control group (15 bilateral cochlear implant users, aged 10-18 years) will receive traditional auditory rehabilitation sessions once a week for 30 minutes over a 4-week period. This group will not participate in the virtual reality intervention.

Behavioral: Traditional Auditory Rehabilitation

Experimental Group (Traditional Auditory Rehabilitation + VR Game)

ACTIVE COMPARATOR

This group will include 15 participants aged 10-18 years with bilateral cochlear implants. In addition to traditional auditory rehabilitation, participants will receive virtual reality (VR) game-based rehabilitation for 30 minutes once a week. The intervention will last for 4 weeks and aims to improve central auditory processing skills.

Device: Virtual Reality (VR) Game for Auditory ProcessingBehavioral: Traditional Auditory Rehabilitation

Interventions

The Virtual Reality (VR) Game is a novel auditory rehabilitation tool designed to enhance central auditory processing skills in children with cochlear implants. This intervention features a restaurant simulation environment where participants perform auditory tasks such as identifying verbal orders, recognizing speech in noisy environments, and matching auditory cues to visual inputs. Dosage Form: Virtual reality sessions conducted through a VR headset (Oculus Meta Quest 3). Frequency: Once per week. Duration per Session: 30 minutes per session. Total Duration: Four weeks (4 sessions). Complexity Levels: Tasks increase in complexity over time, starting with simple auditory cues in quiet environments and progressing to more challenging scenarios involving background noise and multitasking. The VR game is specifically designed to replicate real-world auditory challenges in a controlled and engaging virtual environment, providing participants with tailored tasks to improve auditory atten

Experimental Group (Traditional Auditory Rehabilitation + VR Game)

Name: Traditional Auditory Rehabilitation Description: Participants will continue the standard auditory rehabilitation program they currently receive at their registered rehabilitation center and will focus on improving auditory processing skills. This program includes: Session Length: 30 minutes per session Frequency: Once a week Total Duration: 4 weeks (4 sessions total) Components: Improve speech understanding in noise

Control Group (Traditional Auditory Rehabilitation Only)Experimental Group (Traditional Auditory Rehabilitation + VR Game)

Eligibility Criteria

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

You may qualify if:

  • Being between 10 and 18 years old
  • Having bilateral cochlear implants
  • Having prelingual hearing loss before the age of 2 and having a cochlear implant
  • Having a minimum receptive and expressive language age of 7 on the Peabody Picture-Word Test
  • Having no additional condition that may cause dizziness or balance disorders
  • Having a score in the following ranges on the Child Hearing Performance Scale (CHAPS):
  • Noise Environment item: -7 to -21
  • Multiple Stimuli item: -3 to -9
  • Auditory Memory item: -8 to -24
  • Auditory Attention Span item: -8 to -24
  • Having no diagnosed neurodevelopmental disorder
  • Being a native Turkish speaker
  • Being willing to participate in the study and signing the informed consent form.

You may not qualify if:

  • Individuals younger than 10 or older than 18 years old.
  • Individuals using unilateral cochlear implants.
  • Individuals without prelingual hearing loss or who had a cochlear implant after the age of 2.
  • Individuals with a receptive and expressive language age of under 7 as a result of the Peabody Picture-Word Test.
  • Individuals with dizziness, balance disorders or neurodevelopmental problems.
  • According to the results of the Child Auditory Performance Scale (CHAPS):
  • Those who scored under -7 or over -21 on the "Noise" subscale.
  • Those who scored under -3 or over -9 on the "Multiple Input" subscale.
  • Those who scored under -8 or over -24 on the "Auditory Memory" subscale.
  • Those who scored under -8 or over -24 on the "Auditory Attention Span" subscale.
  • Individuals whose native language is not Turkish.
  • Individuals who did not want to participate in the study and/or did not sign the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Aydın University

Istanbul, Kucukcekmece, 34295, Turkey (Türkiye)

Location

Related Publications (1)

  • Tabak SN, Meral Cetinkaya M, Irali AE. Development and evaluation of a virtual reality game targeting Central auditory processing skills in children using cochlear implants: a randomized controlled trial. Disabil Rehabil Assist Technol. 2026 Feb 4:1-18. doi: 10.1080/17483107.2026.2623465. Online ahead of print.

MeSH Terms

Conditions

Language Development Disorders

Interventions

Auscultation

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This interventional study adopts a parallel group design, comparing the effects of a virtual reality (VR)-based auditory rehabilitation program with traditional auditory rehabilitation methods in children aged 10-18 years who use bilateral cochlear implants. Participants will be randomly assigned to two groups: Intervention Group: Participants in this group will engage in a virtual reality game designed to enhance central auditory processing skills. The VR game includes tasks focusing on auditory attention, working memory, auditory localization, and speech perception in noise. The intervention will consist of weekly 30-minute sessions over a 4-week period. Control Group: Participants in this group will undergo traditional auditory rehabilitation, following established methods aimed at improving similar auditory processing skills. The study model ensures a structured comparison of the effectiveness of the VR intervention against conventional methods.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

January 12, 2025

First Posted

January 23, 2025

Study Start

April 1, 2025

Primary Completion

June 1, 2025

Study Completion

June 15, 2025

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

The individual participant data (IPD) will not be shared to ensure the privacy and confidentiality of the participants. As the study involves a vulnerable group of children with cochlear implants, maintaining their personal data's integrity is of utmost importance. Additionally, the ethical committee's guidelines and institutional policies require strict data protection to prevent potential misuse. Therefore, the IPD will remain confidential and will not be made publicly available.

Locations