Central Auditory Processing DisorderNCT06788184
Virtual Reality Game to Enhance Auditory Processing in Children With Cochlear Implants
A study testing Virtual Reality (VR) Game for Auditory Processing and Traditional Auditory Rehabilitation in people with Central Auditory Processing Disorder, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Central Auditory Processing Disorder
- What is being tested?
- Virtual Reality (VR) Game for Auditory Processing and Traditional Auditory Rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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):
Show all 13Show fewer
- 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.
Who cannot join
- 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):
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Aydın University
Istanbul, Kucukcekmece, 34295
About this study
Official title: Development and Evaluation of the Effectiveness of a Virtual Reality Game Targeting Central Auditory Processing Skills in Children Using Cochlear Implants
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.
Read the 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.
- Conditions
- Central Auditory Processing Disorder
- Being tested
- Virtual Reality (VR) Game for Auditory Processing, Traditional Auditory Rehabilitation
- Keywords
- Cochlear Implant, Auditory Processing, Virtual Reality, Auditory Attention, Working Memory
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality (VR) Game for Auditory ProcessingDevice
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
Traditional Auditory RehabilitationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Virtual Reality (VR) Game for Auditory Processing; Behavioral: Traditional Auditory Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The outcome will be assessed at Baseline (Week 0) and Post-Intervention (Week 4), with improvements in scores reflecting better speech perception in noise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start1 Apr 2025
- Primary completion1 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Auditory Processing DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyma Nur TABAK, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788184
- Sponsor's protocol ID
- 37/2024
- Other IDs
- Scientific Research Projects
- Status last verified
- Jul 2025
- First submitted
- 12 Jan 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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 Jul;21(5):2211-2228. doi: 10.1080/17483107.2026.2623465. Epub 2026 Feb 4.
PubMed 41636301
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of the Effectiveness of a Virtual Reality Game Targeting Central Auditory Processing Skills in Children Using Cochlear Implants
- ClinicalTrials.gov ID
- NCT06788184
- Acronym / sponsor ID
- 37/2024
- Conditions
- Central Auditory Processing Disorder
- Keywords
- Cochlear Implant, Auditory Processing, Virtual Reality, Auditory Attention, Working Memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group (Traditional Auditory Rehabilitation Only) | Active comparator | Behavioral: Traditional Auditory RehabilitationParticipants 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. |
| Experimental Group (Traditional Auditory Rehabilitation + VR Game) | Active comparator | Device: Virtual Reality (VR) Game for Auditory Processing, Behavioral: Traditional Auditory RehabilitationThis 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality (VR) Game for Auditory ProcessingThe 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 | Device | Experimental Group (Traditional Auditory Rehabilitation + VR Game) |
| Traditional Auditory RehabilitationName: 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 | Behavioural | Control Group (Traditional Auditory Rehabilitation Only), Experimental Group (Traditional Auditory Rehabilitation + VR Game) |
Primary outcome
Change from Baseline in Speech Recognition in Noise Using the Hearing in Noise Test (HINT)
Time frame: The outcome will be assessed at Baseline (Week 0) and Post-Intervention (Week 4), with improvements in scores reflecting better speech perception in noise.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Derived from this study: PubMed 41636301Tabak 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 Jul;21(5):2211-2228. doi: 10.1080/17483107.2026.2623465. Epub 2026 Feb 4.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality (VR) Game for Auditory Processing and Traditional Auditory Rehabilitation in people with Central Auditory Processing Disorder, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Speech Recognition in Noise Using the Hearing in Noise Test (HINT) (time frame: The outcome will be assessed at Baseline (Week 0) and Post-Intervention (Week 4), with improvements in scores reflecting better speech perception in noise.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06788184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.