Clinical trial NCT06788184: Virtual Reality Game to Enhance Auditory Processing in Children With Cochlear Implants
Official title: Development and Evaluation of the Effectiveness of a Virtual Reality Game Targeting Central Auditory Processing Skills in Children Using Cochlear Implants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Central Auditory Processing Disorder
Keywords: Cochlear Implant
Auditory Processing
Virtual Reality
Auditory Attention
Working Memory
Lead sponsor: Istanbul Aydın University
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: This study aims to develop and evaluate a virtual reality (VR) game designed to improve central auditory processing skills in children aged 10-18 years with bilateral cochlear implants. The project aims to test the effectiveness of an innovative VR platform as a complement to traditional auditory rehabilitation methods. It focuses on improving critical skills such as auditory attention in noise, working memory, auditory localization and speech perception.

Scope of the Study:

Participant Profile: Children aged 10-18 years with prelingual hearing loss who received bilateral cochlear implants before the age of 2. Participants will be selected according to the criteria of the Child Auditory Performance Scale (CHAPS) and a minimum age of 7 years for receptive and expressive language as a result of the Peabody Picture Word Test.

Methodology: The study will compare traditional auditory rehabilitation (control group) with VR-based rehabilitation (study group). The VR rehabilitation process will consist of weekly 30-minute sessions lasting a total of 4 weeks. The assessment tools will include the Hearing in Noise Test (HINT).

Scales and Forms to be Used in the Pilot Study: The following tools and forms will be used in the pilot phase to comprehensively evaluate the effectiveness and usability of the game:

Demographic Information Forms:

Demographic information form for children using cochlear implants. Demographic information form for children with normal hearing. Game Observation Checklist: Used to systematically observe and document participants' interactions with the game.

Virtual Reality Game Test List: To evaluate specific tasks and performance results in the VR game.

System Usability Scale (SUS): Will be administered to parents to evaluate the usability of the VR system. Parents will provide insight into how their children experienced the game and their perceptions of the usability process.

Parent One-on-One Interview Form: To collect feedback from parents about the impact and effectiveness of the game. Child Game Evaluation Form: To collect direct feedback from children about their experiences with the VR game.

Participant One-on-One Interview Form: To document qualitative data from participants about their experiences and challenges.

The feedback received from 10 participants and their parents in the pilot phase will play a critical role in improving the game mechanics and ensuring the effectiveness of the system.

Innovative Aspects and Contributions: The innovative aspect of the study is the use of virtual reality technology in auditory rehabilitation. In the VR environment, participants will undertake tasks in a realistic restaurant simulation by adapting to increasing levels of difficulty to improve their auditory skills. The study aims to achieve improvements in auditory attention, working memory and speech perception in noise of the participants, exceeding the results of traditional methods.

It is expected that the results of this study will contribute to the development of new strategies for the rehabilitation of individuals with hearing loss and enable them to participate more effectively in daily life. In addition, the developed VR game will support the education and social integration of hearing impaired individuals while raising awareness in society. It is planned that the scientific findings of the study will be published in national and international journals and form the basis for the development of various rehabilitation programs.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Baseline in Speech Recognition in Noise Using the Hearing in Noise Test (HINT)
timeFrame: The outcome will be assessed at Baseline (Week 0) and Post-Intervention (Week 4), with improvements in scores reflecting better speech perception in noise.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Aydın University
state: Kucukcekmece
Study officials:
References: