Evaluation of Cochlear Implantation in Unilateral or Asymmetric Hearing Loss in Children.
NCT ID: NCT06930170
Last Updated: 2025-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
36 participants
INTERVENTIONAL
2025-06-30
2029-04-30
Brief Summary
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Detailed Description
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Recent research has also indicated that in children with unilateral deafness, the better ear may be affected by sensory deprivation in the impaired ear. Despite these substantial effects, treatment options for these children remain limited. Traditional hearing aids are insufficient to restore functional hearing in cases of profound deafness. The only routinely available options are a Bone-Anchored Hearing Aid (BAHA) or a Contralateral Routing of Sound (CROS) system. While these devices allow the signal from the affected side to be transmitted to the better ear, they do not restore binaural hearing, unlike cochlear implants (CIs).
A growing body of evidence has demonstrated the benefits of cochlear implantation on speech perception in noise and sound localization in adults. However, in France, CIs are currently indicated only for cases of severe to profound unilateral deafness associated with debilitating tinnitus, and only when alternative treatments-such as CROS systems and osseointegrated hearing aids-have failed in children. While studies suggest that children may achieve similar outcomes, no clinical research has been conducted. This study aims to evaluate functional performance and neurological correlates in unilaterally implanted children with unilateral hearing loss, in comparison with their hearing-aided peers
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cochlear implant
Fitted with a cochlear implant
CROS or BiCROS device fitting
At 8 weeks after inclusion, CROS or BICROS (depending on the type of hearing loss) is fitting
French simplified matrix test (FraSimat)
The FraSimat is an adaptive test that measures speech intelligibility in noise. It consists of 14 sentences of 3 words each, recorded in the presence of background noise. The FraSimat will be performed in two different configurations in relation to the source of the signal and noise before implantation or fitting, and 1, 2, 3 and 4 months after.
Sound localization test (ERKI)
ERKI for German "Erfassung des Richtungshörens für Kinder" is an automated test that assesses spatial localization skills. The test is performed with the child seated facing a semi-circular table, surrounded by a set of 5 loudspeakers arranged 1 meter apart.
The test consists of 5 stimuli, followed by 42 trials. Following the presentation of each stimulus, the child must turn a control knob and direct the LED light to the point where he or she has perceived it. The child validates his or her response by pressing the button.
ERKI is evaluated before implantation or fitting, and 1, 2 and 3 months after.
Cortical Auditory Evoked Potentials (PEAc)
The recording of Auditory Cortical Evoked Potentials provides an objective means of assessing the maturation of the auditory system and its ability to process auditory signals. AEPs consist of a series of cortical responses to an auditory stimulus.
PEAc are assessed using a non-invasive EEG recording, made under quiet wakefulness. Four surface electrodes are glued to the patient's skull: one on the vertex, one on the forehead, and one on each mastoid. The latency (msec) and amplitude (mV) values of each of the four component waves will be analyzed.
PEAc is evaluated before implantation or fitting, and 3 and 4 months after.
Speech, Spatial and Qualities of Hearing Scale (SSQ)
The Speech, Spatial and Qualities of Hearing Scale is a questionnaire for subjective evaluation of listening performance in everyday listening situations. The parent version is adapted for parents of hearing-impaired children.
SSQ is evaluated before implantation or fitting, and 4 months after.
Peabody Picture Vocabulary Scale (PPVT or EVIP in french)
Peabody Picture Vocabulary Scale assesses the extent of French listening vocabulary acquired by the child.
The PPVT is designed for patients aged from 2 years and 6 months to 18 years. The raw score is the number of images correctly identified.
Peabody Picture Vocabulary Scale is evaluated before implantation or fitting, and 4 months after.
NEPSY-II (A Developmental Neuropsychological Assessment)
The NEPSY-II (A Developmental Neuropsychological Assessment) is a battery of neuropsychological tests designed to assess children's skills in 6 major neuropsychological domains. The various tests are validated for the age range indicated in brackets, and will be used for patients aged 5 and over.
NEPSY-II is evaluated before implantation or fitting, and 4 months after.
Pediatric Quality of Life Inventory™ Multidimensional Fatigue Scale (PedsQL MFS)
PedsQL MFS is a questionnaire used to assess subjective experiences of fatigue. The questionnaire consists of 18 items The parent version is adapted for parents of hearing-impaired children. PedsQL MFS is evaluated before implantation or fitting, and 4 months after.
CROS or biCROS system
Fitted with a CROS or BiCROS system, depending on the type of hearing loss
Cochlear implantation
During surgery at 8 weeks after inclusion, cochlear implant is implanted
French simplified matrix test (FraSimat)
The FraSimat is an adaptive test that measures speech intelligibility in noise. It consists of 14 sentences of 3 words each, recorded in the presence of background noise. The FraSimat will be performed in two different configurations in relation to the source of the signal and noise before implantation or fitting, and 1, 2, 3 and 4 months after.
Sound localization test (ERKI)
ERKI for German "Erfassung des Richtungshörens für Kinder" is an automated test that assesses spatial localization skills. The test is performed with the child seated facing a semi-circular table, surrounded by a set of 5 loudspeakers arranged 1 meter apart.
The test consists of 5 stimuli, followed by 42 trials. Following the presentation of each stimulus, the child must turn a control knob and direct the LED light to the point where he or she has perceived it. The child validates his or her response by pressing the button.
ERKI is evaluated before implantation or fitting, and 1, 2 and 3 months after.
Cortical Auditory Evoked Potentials (PEAc)
The recording of Auditory Cortical Evoked Potentials provides an objective means of assessing the maturation of the auditory system and its ability to process auditory signals. AEPs consist of a series of cortical responses to an auditory stimulus.
PEAc are assessed using a non-invasive EEG recording, made under quiet wakefulness. Four surface electrodes are glued to the patient's skull: one on the vertex, one on the forehead, and one on each mastoid. The latency (msec) and amplitude (mV) values of each of the four component waves will be analyzed.
PEAc is evaluated before implantation or fitting, and 3 and 4 months after.
Speech, Spatial and Qualities of Hearing Scale (SSQ)
The Speech, Spatial and Qualities of Hearing Scale is a questionnaire for subjective evaluation of listening performance in everyday listening situations. The parent version is adapted for parents of hearing-impaired children.
SSQ is evaluated before implantation or fitting, and 4 months after.
Peabody Picture Vocabulary Scale (PPVT or EVIP in french)
Peabody Picture Vocabulary Scale assesses the extent of French listening vocabulary acquired by the child.
The PPVT is designed for patients aged from 2 years and 6 months to 18 years. The raw score is the number of images correctly identified.
Peabody Picture Vocabulary Scale is evaluated before implantation or fitting, and 4 months after.
NEPSY-II (A Developmental Neuropsychological Assessment)
The NEPSY-II (A Developmental Neuropsychological Assessment) is a battery of neuropsychological tests designed to assess children's skills in 6 major neuropsychological domains. The various tests are validated for the age range indicated in brackets, and will be used for patients aged 5 and over.
NEPSY-II is evaluated before implantation or fitting, and 4 months after.
Pediatric Quality of Life Inventory™ Multidimensional Fatigue Scale (PedsQL MFS)
PedsQL MFS is a questionnaire used to assess subjective experiences of fatigue. The questionnaire consists of 18 items The parent version is adapted for parents of hearing-impaired children. PedsQL MFS is evaluated before implantation or fitting, and 4 months after.
Interventions
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Cochlear implantation
During surgery at 8 weeks after inclusion, cochlear implant is implanted
CROS or BiCROS device fitting
At 8 weeks after inclusion, CROS or BICROS (depending on the type of hearing loss) is fitting
French simplified matrix test (FraSimat)
The FraSimat is an adaptive test that measures speech intelligibility in noise. It consists of 14 sentences of 3 words each, recorded in the presence of background noise. The FraSimat will be performed in two different configurations in relation to the source of the signal and noise before implantation or fitting, and 1, 2, 3 and 4 months after.
Sound localization test (ERKI)
ERKI for German "Erfassung des Richtungshörens für Kinder" is an automated test that assesses spatial localization skills. The test is performed with the child seated facing a semi-circular table, surrounded by a set of 5 loudspeakers arranged 1 meter apart.
The test consists of 5 stimuli, followed by 42 trials. Following the presentation of each stimulus, the child must turn a control knob and direct the LED light to the point where he or she has perceived it. The child validates his or her response by pressing the button.
ERKI is evaluated before implantation or fitting, and 1, 2 and 3 months after.
Cortical Auditory Evoked Potentials (PEAc)
The recording of Auditory Cortical Evoked Potentials provides an objective means of assessing the maturation of the auditory system and its ability to process auditory signals. AEPs consist of a series of cortical responses to an auditory stimulus.
PEAc are assessed using a non-invasive EEG recording, made under quiet wakefulness. Four surface electrodes are glued to the patient's skull: one on the vertex, one on the forehead, and one on each mastoid. The latency (msec) and amplitude (mV) values of each of the four component waves will be analyzed.
PEAc is evaluated before implantation or fitting, and 3 and 4 months after.
Speech, Spatial and Qualities of Hearing Scale (SSQ)
The Speech, Spatial and Qualities of Hearing Scale is a questionnaire for subjective evaluation of listening performance in everyday listening situations. The parent version is adapted for parents of hearing-impaired children.
SSQ is evaluated before implantation or fitting, and 4 months after.
Peabody Picture Vocabulary Scale (PPVT or EVIP in french)
Peabody Picture Vocabulary Scale assesses the extent of French listening vocabulary acquired by the child.
The PPVT is designed for patients aged from 2 years and 6 months to 18 years. The raw score is the number of images correctly identified.
Peabody Picture Vocabulary Scale is evaluated before implantation or fitting, and 4 months after.
NEPSY-II (A Developmental Neuropsychological Assessment)
The NEPSY-II (A Developmental Neuropsychological Assessment) is a battery of neuropsychological tests designed to assess children's skills in 6 major neuropsychological domains. The various tests are validated for the age range indicated in brackets, and will be used for patients aged 5 and over.
NEPSY-II is evaluated before implantation or fitting, and 4 months after.
Pediatric Quality of Life Inventory™ Multidimensional Fatigue Scale (PedsQL MFS)
PedsQL MFS is a questionnaire used to assess subjective experiences of fatigue. The questionnaire consists of 18 items The parent version is adapted for parents of hearing-impaired children. PedsQL MFS is evaluated before implantation or fitting, and 4 months after.
Eligibility Criteria
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Inclusion Criteria
* Using spoken French as the primary mode of communication
* Diagnosed with unilateral or asymmetric hearing loss :
Unilateral is defined by severe to profound hearing loss in the affected ear (thresholds \> 70 dB at ≥ 4 frequencies, established by audiometry or ASSR) and normal hearing in the better ear (thresholds ≤ 25 dB between 500-4000 Hz, established by audiometry or ASSR).
Asymmetric is defined by severe to profound hearing loss in the weaker ear (thresholds \> 70 dB at ≥ 4 frequencies, established by audiometry or ASSR) and mild hearing loss in the better ear (thresholds between 30-40 dB at ≤ 4 frequencies, established by audiometry or ASSR).
* Written informed consent from both legal guardians (or the sole guardian, if applicable)
* Affiliated with a health insurance system or entitled to coverage
Exclusion Criteria
* Severe cognitive, child psychiatric, or developmental delay
* Severe cochleo-vestibular malformation
* Severe cochlear nerve malformation
* Social circumstances preventing long-term follow-up
* Family not proficient in spoken French
* Patient fitted with a CROS or BiCROS system
* Patient with a contraindication to implantation surgery or anesthesia (including lack of meningitis/pneumococcal vaccination)
4 Years
6 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Nathalie LOUNDON, MD, PHD
Role: STUDY_CHAIR
Unité d'Audiophonologie et d'Implantation cochléaire - Service d'ORL et chirurgie cervico-faciale Hôpital Necker.
Locations
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Audiophonology Unit of the Ear, Nose and Throat (ENT) Department ("Oto-rhino-laryngologie (ORL) et chirurgie cervico-faciale")
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Centre de Recherche en Audiologie Pédiatrique - Hôpital Necker
Role: primary
Other Identifiers
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2023-A00003-42
Identifier Type: OTHER
Identifier Source: secondary_id
APHP220669
Identifier Type: -
Identifier Source: org_study_id
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