Spatial Hearing Rehabilitation in Noise for Bilateral Cochlear Implant Children

Cochlear Implantation Clinical Trial

— KidTrain  

Official title:

Spatial Hearing Rehabilitation in Noise for Bilateral Cochlear Implant Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06040892
• Other study ID #: 69HCL22_0893
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2024
• Est. completion date: August 2027

Study information

• Verified date: April 2024
• Source: Hospices Civils de Lyon
• Contact: Aurélie Coudert, MD
• Phone: 0427855506
• Email: aurelie.coudert2[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In recent decades, there was a great expansion for bilateral cochlear implantation (bCI) in children, leading to an improvement of their quality of life. However, spatial hearing skills of bCI children remain limited, even for children with the best speech understanding outcomes. Recent studies have brought new insights in spatial hearing by using virtual reality to record spatial hearing performance in 3D and the impact of active listening (i.e. free head exploration during sound emission): all bCI children showed spatial hearing difficulties related to front-back confusions and distance perception, which partly resulted from the reduction in auditory cues by the CI settings. However, bCI children notably improved under conditions of active listening, suggesting that interaction with environment could represent a rehabilitation entry strategy to help bCI users when faced with complex auditory scenes in daily life.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: August 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

Inclusion Criteria:

• Child aged between 7 and 17 years

• 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:

• Bilateral vestibular areflexia,

• 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.

Related Conditions & MeSH terms

• Cochlear Implantation

Intervention

Diagnostic Test:
• 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.

Other:
• 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).

Locations

Country	Name	City	State
France	Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale Hôpital Edouard Herriot, Groupement Hospitalier Centre	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (3)

Coudert A, Gaveau V, Gatel J, Verdelet G, Salemme R, Farne A, Pavani F, Truy E. Spatial Hearing Difficulties in Reaching Space in Bilateral Cochlear Implant Children Improve With Head Movements. Ear Hear. 2022 Jan/Feb;43(1):192-205. doi: 10.1097/AUD.0000000000001090. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the very short-term effects of spatial rehabilitation on the auditory performance of bCI children.	The effect of spatial rehabilitation will be defined as any change in auditory performance (SPHERE value), between the initial assessment and after 4 training sessions.	Immediately after 4 training sessions - day 42
Primary	To evaluate the very short-term effects of spatial rehabilitation on the auditory performance of bCI children.	The effect of spatial rehabilitation will be defined as any change in auditory performance (FRASIMAT value), between the initial assessment and after 4 training sessions.	Immediately after 4 training sessions - day 42
Primary	To evaluate the very short-term effects of spatial rehabilitation on the auditory performance of bCI children.	The effect of spatial rehabilitation will be defined as any change in auditory performance (KID-SSQ score), between the initial assessment and after 4 training sessions.	Immediately after 4 training sessions - day 42
Secondary	To evaluate the compliance of bCI children with the rehabilitation protocol	Number of training sessions attended by bCI patients	At the end of the study ( Visit 13 - day 98)
Secondary	To evaluate the impact of a spatialized sensory index in rehabilitation.	Measures obtained at the E2 assessment (SPHERE value) between the group of bCI children in group A and those in group B.	At the end of the study ( Visit 13 - day 98)
Secondary	To evaluate the impact of a spatialized sensory index in rehabilitation.	Measures obtained at the E2 assessment (FRASIMAT value) between the group of bCI children in group A and those in group B.	At the end of the study ( Visit 13 - day 98)
Secondary	To evaluate the impact of a spatialized sensory index in rehabilitation.	Measures obtained at the E2 assessment (KID-SSQ score) between the group of bCI children in group A and those in group B.	At the end of the study ( Visit 13 - day 98)
Secondary	To evaluate the effect in the very short/short and medium term of spatial hearing rehabilitation on the spatial sound localization performance of bIC children compared to NH children	SPHERE confusion rates (front-back, up-down, near-far) for bCI children at E2, E3 and E4 and NH children at E0.	At evaluation visits Day 0, 42, 77 and 98
Secondary	To evaluate the effect of very short-term, short-term and medium-term spatial hearing rehabilitation on the speech comprehension performance of bIC children compared to NH children.	FRASIMAT noise intelligibility scores for bCI children in E2, E3 and E4 and those for NH children in E0.	At evaluation visits Day 0, 42, 77 and 98
Secondary	To evaluate the effect of very short-term and short-term and medium-term spatial hearing rehabilitation on the quality of life performance of bIC children compared to NH children.	KID-SSQ spatial hearing scores obtained by bCI children in E2, E3 and E4 and those obtained by NH children in E0.	At evaluation visits Day 0, 42, 77 and 98
Secondary	To assess the absence of spontaneous changes in auditory performance.	SPHERE measure for the bCI and NH groups between the E0 and E1 assessments.	At day 0 and 7
Secondary	To assess the absence of spontaneous changes in auditory performance.	FRASIMAT measure for the bCI and NH groups between the E0 and E1 assessments.	At day 0 and 7
Secondary	To assess the absence of spontaneous changes in auditory performance.	KID SSQ measure for the bCI and NH groups between the E0 and E1 assessments.	At day 0 and 7