Spatial Hearing Rehabilitation in Noise for Bilateral Cochlear Implant Children
NCT ID: NCT06040892
Last Updated: 2026-02-10
Study Results
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Basic Information
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RECRUITING
NA
56 participants
INTERVENTIONAL
2024-03-27
2027-11-30
Brief Summary
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The ability to localize sounds in space (spatial hearing) and the ability to understand speech in noise are both auditory skills essential in daily interactions with our physical and social environment and, when deficient, limit the quality of life. However, there is no specific rehabilitation program devoted to spatial hearing which could help children face their daily difficulties in noisy environments. Even though technological advances are crucial to improve the restoration of hearing functions, these improvements are also highly dependent on rehabilitation strategies to train our auditory brain to face the restoration of binaural processing or to decode the impoverished spectral information delivered by the CI.
The investigators recently performed a pilot study in bCI adults who attended 8 training sessions of spatial hearing, involving a sensorial and interactive immersive environment (i.e. virtual reality with auditory and visual environment during an active listening task). All participants benefitted of the training, in terms of spatial hearing performance, speech understanding in noise, and quality of life. All early benefits were maintained 1 month after the end of training.
The investigators aim to propose a spatial hearing rehabilitation program (KidTrain) adapted to bCI children from 8 to 17 years old, based on their previous pilot study on bCI adults. Their tool makes it possible to propose rehabilitation programs adapted to the performance and expectations of each child. This program will manipulate both the ambient sound with varying background noise to simulate daily life environments (i.e. making auditory detection more or less complex), and also manipulate virtual immersive environment (i.e. giving more or less relevant visual cues related to real sound location). The KidTrain's effects will be measured with different auditory tests performed in noisy environments. The investigators will also include Normal Hearing (NH) children as age-matched control groups to perform the auditory tests in noise. These NH groups will also bring new insights of spatial hearing maturation in complex auditory environments. Based on our preliminary data in bCI adults, this 'KidTrain program' should improve spatial hearing skills of bCI children, speech comprehension in noise and quality of life in many daily situations.
Virtual reality (VR) has recently proven its effectiveness in rehabilitation in many domains and recent studies have shown that this technology has its place in the auditory evaluation and adaptation of spatial hearing. This VR approach takes advantage of the control of multisensory cues of our environment (audio and visual) during a spatial hearing task, and allows the subject to interact with his environment according to his hearing abilities and needs (i.e. active listening).
Based on their previous study conducted in bCI and NH children and on their spatial training study conducted with bCI adults, the investigators wish to respond to the growing need of spatial hearing rehabilitation for bCI children. To achieve this goal, the investigators will improve the spatial training program by adding different immersive environment in VR with various background noise to simulate daily life environments. This approach will also be a great opportunity to characterize the developmental stages of spatial hearing maturation in NH children. Thus, this project will propose new axes of speech therapy on the Orthophonie \& Surdité platform, combining spatial hearing and speech understanding in noise. This innovative and adapted rehabilitation program will lead the speech therapist to propose more adapted and effective rehabilitations for the daily life of deaf children.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Group A
bilateral cochlear implant children with rehabilitation including 8 sessions with a spatialized sensory index
spatial hearing rehabilitation program
The tool makes it possible to propose rehabilitation programs adapted to the performance and expectations of each child. This program will manipulate both the ambient sound with varying background noise to simulate daily life environments (i.e. making auditory detection more or less complex), and also manipulate virtual immersive environment (i.e. giving more or less relevant visual cues related to real sound location).
SPHERE protocol : Spatial hearing performances test
Participants will be instructed to localize a sound emitted in their environment using a virtual reality setup (SPHERE protocol).
FRASIMAT Test : audiology test of speech in noise perception
Intelligibility threshold is the signal-to-noise ratio (in decibels) for which the subject can repeat 50% of the words heard in a dichotic listening.
Kid SSQ questionnaire of life : The Speech, Spatial and Other Qualities of Hearing Scale
The SSQ questionnaire is a clinical subjective scale that allows evaluating of hearing performances in daily life. The questionnaire is divided into 3 main items (A: speech; B: spatial hearing; C: other qualities of hearing) comprising questions with rating scores out of ten.
Group B
bilateral cochlear implant children with rehabilitation including initially 4 sessions without spatialized sensory cue followed by 4 sessions with spatialized sensory cue
spatial hearing rehabilitation program
The tool makes it possible to propose rehabilitation programs adapted to the performance and expectations of each child. This program will manipulate both the ambient sound with varying background noise to simulate daily life environments (i.e. making auditory detection more or less complex), and also manipulate virtual immersive environment (i.e. giving more or less relevant visual cues related to real sound location).
SPHERE protocol : Spatial hearing performances test
Participants will be instructed to localize a sound emitted in their environment using a virtual reality setup (SPHERE protocol).
FRASIMAT Test : audiology test of speech in noise perception
Intelligibility threshold is the signal-to-noise ratio (in decibels) for which the subject can repeat 50% of the words heard in a dichotic listening.
Kid SSQ questionnaire of life : The Speech, Spatial and Other Qualities of Hearing Scale
The SSQ questionnaire is a clinical subjective scale that allows evaluating of hearing performances in daily life. The questionnaire is divided into 3 main items (A: speech; B: spatial hearing; C: other qualities of hearing) comprising questions with rating scores out of ten.
Normal hearing volunteers
Children without known hearing loss
SPHERE protocol : Spatial hearing performances test
Participants will be instructed to localize a sound emitted in their environment using a virtual reality setup (SPHERE protocol).
FRASIMAT Test : audiology test of speech in noise perception
Intelligibility threshold is the signal-to-noise ratio (in decibels) for which the subject can repeat 50% of the words heard in a dichotic listening.
Kid SSQ questionnaire of life : The Speech, Spatial and Other Qualities of Hearing Scale
The SSQ questionnaire is a clinical subjective scale that allows evaluating of hearing performances in daily life. The questionnaire is divided into 3 main items (A: speech; B: spatial hearing; C: other qualities of hearing) comprising questions with rating scores out of ten.
Interventions
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spatial hearing rehabilitation program
The tool makes it possible to propose rehabilitation programs adapted to the performance and expectations of each child. This program will manipulate both the ambient sound with varying background noise to simulate daily life environments (i.e. making auditory detection more or less complex), and also manipulate virtual immersive environment (i.e. giving more or less relevant visual cues related to real sound location).
SPHERE protocol : Spatial hearing performances test
Participants will be instructed to localize a sound emitted in their environment using a virtual reality setup (SPHERE protocol).
FRASIMAT Test : audiology test of speech in noise perception
Intelligibility threshold is the signal-to-noise ratio (in decibels) for which the subject can repeat 50% of the words heard in a dichotic listening.
Kid SSQ questionnaire of life : The Speech, Spatial and Other Qualities of Hearing Scale
The SSQ questionnaire is a clinical subjective scale that allows evaluating of hearing performances in daily life. The questionnaire is divided into 3 main items (A: speech; B: spatial hearing; C: other qualities of hearing) comprising questions with rating scores out of ten.
Eligibility Criteria
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Inclusion Criteria
* Normal vision (including correction),
* Able to understand the experimental instructions,
* Parents or guardians informed of the study and having signed the consent form,
Specific for NH:
* Normal tone audiometry (mean threshold ≤ 30 dB). Specific for bIC
* Minimum 2 years of binaural experience,
* Average speech recognition ≥ 80% with both cochlear implants
Exclusion Criteria
* Attention deficit disorder,
* Known neurological or psychiatric disorders,
* Oculomotor disorders,
* Parents not affiliated to a social security scheme or beneficiaries of a similar scheme who sign the consent for the child's participation,
* Subject participating in other interventional research with an exclusion period still ongoing at inclusion.
7 Years
17 Years
ALL
Yes
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Aurélie Coudert, MD
Role: STUDY_CHAIR
Hospices Civils de Lyon
Locations
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Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale Hôpital Edouard Herriot, Groupement Hospitalier Centre
Lyon, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Yuzefovsky AI, Lonardo RF, Michel RG. Spatial discrimination against background with different optical systems for collection of fluorescence in laser-excited atomic fluorescence spectrometry with a graphite tube electrothermal atomizer. Anal Chem. 1995 Jul 1;67(13):2246-55. doi: 10.1021/ac00109a052.
Valzolgher C, Gatel J, Bouzaid S, Grenouillet S, Todeschini M, Verdelet G, Salemme R, Gaveau V, Truy E, Farne A, Pavani F. Reaching to Sounds Improves Spatial Hearing in Bilateral Cochlear Implant Users. Ear Hear. 2023 Jan-Feb 01;44(1):189-198. doi: 10.1097/AUD.0000000000001267. Epub 2022 Aug 19.
Coudert A, Verdelet G, Reilly KT, Truy E, Gaveau V. Intensive Training of Spatial Hearing Promotes Auditory Abilities of Bilateral Cochlear Implant Adults: A Pilot Study. Ear Hear. 2023 Jan-Feb 01;44(1):61-76. doi: 10.1097/AUD.0000000000001256. Epub 2022 Aug 9.
Other Identifiers
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69HCL22_0893
Identifier Type: -
Identifier Source: org_study_id
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