- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04738968
Cochlear Implantation for Young Single-sided Deaf Children (CICADE)
Cochlear Implant for Young Children and One Deaf Ear
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The main objective of the research project is to fundamentally investigate spatial and binaural hearing in a group of children with a normal hearing ear (NH) and a cochlear implant (CI) longitudinally in order to understand the relationship between sensory experience and auditory cortex plasticity. This relationship is most striking during infancy when changes in sensory input can have profound effects on the functional organization of the developing cortex. Recent studies in the auditory system have revealed the remarkably adaptive nature of sensory processing and provided important insights into the way in which cortical circuits are shaped by experience and learning. The binaural system processes and integrates differences in phase (low frequencies) or intensity (high frequencies) between sounds arriving at the left and right ear and this process goes on from birth up to adulthood. It is expected that cochlear implantation will promote normal or near-normal spatial-hearing skills in children with UHL and that intervention at 2 years of age yields the best conditions for (near-) normal development of cognition, spoken language, balance, and psychopathology, outcomes which will be monitored annually too.
Fifteen NH-CI children, aged 2 or younger, will receive a cochlear implant. This device has already been provided to over 400.000 bilaterally profoundly deaf persons worldwide and is considered a standard treatment. The novelty of the present studies lies in the treatment of unilaterally deaf children with a cochlear implant. Because of the cost of this device, the Belgian government does not reimburse a CI for children with unilateral hearing impairment, which is why a study is done to demonstrate its effectiveness. The 15 devices are provided by Cochlear. While the sample size may seem small, providing the device (25.000€ a piece) and some follow-up (mapping and/or remediation) are a large investment for Cochlear Ltd. The children will act as their own control (tested with and without CI) when possible. In addition, at the start of the research project the NH-CI children will be age-matched with 15 normal hearing children (NH-NH), and with 15 children with unilateral hearing loss without a CI (NH - x). Care will be taken to control for as many other factors as possible (e.g. other disabilities, parental and socioeconomic characteristics, ..).
It is hypothesized that the children with UHL and a CI (NH-CI) will outperform children without intervention (NH-x) because of access to bilateral input, and that provision at a very young age will result in near-normal binaural processing in the following years and hence better auditory/neuro/cognitive processing and learning in general. After cochlear implantation, the children will be followed up in terms of language development, cognitive development, binaural hearing, and academic achievements.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Antwerp, Belgium
- Antwerp University Hospital
-
Antwerp, Belgium
- GZA Hospitals
-
Ghent, Belgium
- Ghent University Hospital
-
Leuven, Belgium
- University Hospitals Leuven
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- profoundly hearing impaired in one ear
- normal hearing in contralateral ear
Exclusion Criteria:
none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cochlear implant for single-sided deafness
Children with single-sided deafness, cochlear implant in the deaf ear
|
A cochlear implant is standard care for profoundly deaf persons.
It enables hearing through electrical stimulation of the auditory nerve.
|
No Intervention: Control single-sided deafness
Children with single-sided deafness, no intervention
|
|
No Intervention: Control normal hearing
Children with normal hearing, no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spoken language comprehension
Time Frame: Every 6 months between 2nd and 5th birthday
|
The Schlichting Test for Receptive Language is a language comprehension test for children aged 2 to 7 years.
Results are reported as an age-referenced language comprehension quotient based on the total score.
|
Every 6 months between 2nd and 5th birthday
|
Spoken language production (young children)
Time Frame: Every 6 months between 2nd and 5th birthday
|
The Schlichting Test for Expressive Language is a language production test for children aged 2 to 7 years.
Results are reported as age-referenced language quotients for each subtest, namely (1) expressive vocabulary, (2) morphosyntactic skills, (3) auditory memory, (4) pseudoword repetition, (5) story telling.
|
Every 6 months between 2nd and 5th birthday
|
Spoken language production (older children)
Time Frame: Yearly from the age of 5, until study completion (average period: 2 years)
|
The Clinical Evaluation of Language Fundamentals (CELF-4-NL) is a language test for children aged 5 to 18 years.
Results are reported as age-referenced scores for some of the subtests, namely (1) word structure, (2) sentence repetition, (3) sentence production, (4) word categories, (5) phonologic awareness.
|
Yearly from the age of 5, until study completion (average period: 2 years)
|
Spatial speech perception in noise
Time Frame: Yearly from the age of 4, until study completion (average period: 3 years)
|
Speech perception in noise is measured for three spatial conditions using the LittleLINT speech material (numbers 1-10).
Results are reported for each condition as the speech reception threshold, i.e. the level (in decibel signal-to-noise ratio, dB SNR) at which 50% of the speech is understood.
Children with a CI are tested both with and without their device.
|
Yearly from the age of 4, until study completion (average period: 3 years)
|
Sound localization
Time Frame: Yearly from the age of 4, until study completion (average period: 3 years)
|
Sound localization is assessed in a 9-loudspeaker setup with 15° degrees spacing between the loudspeakers.
The stimulus is a 1-second broadband telephone sound.
Results are reported as the mean absolute error, i.e. the average difference (in degrees) between the active loudspeaker and the child's response.
Children with a CI are tested both with and without their device.
|
Yearly from the age of 4, until study completion (average period: 3 years)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive development (young children)
Time Frame: Every 6 months until the age of 3.5 years
|
The Bayley Scales of Infant and Toddler Development (Bayley-III-NL) is a developmental test for children aged 0 to 4 years and includes cognitive, language, and motor assessment scales.
Results are reported as an age-referenced cognitive quotient for the cognitive scale.
|
Every 6 months until the age of 3.5 years
|
Cognitive development (older children)
Time Frame: At 4 and 6 years of age (i.e. twice in total)
|
The Wechsler Preschool & Primary Scale of Intelligence (WPPSI-III-NL) is a cognitive development test for children aged 2 to 8 years.
Results are reported as age-referenced composite scores or intelligence quotients (IQs), namely (1) full IQ, (2) verbal IQ, (3) performance IQ, (4) processing speed.
|
At 4 and 6 years of age (i.e. twice in total)
|
Functional balance
Time Frame: Yearly from the age of 4, until study completion (average period: 3 years)
|
The Balance scale of the Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) provides a nine-item screening for balance problems, for children aged 4 to 22 years.
Results are reported as an age-referenced standard score.
|
Yearly from the age of 4, until study completion (average period: 3 years)
|
Speech perception with the cochlear implant alone
Time Frame: At clinical visits after the age of 3, on average 2 times per year, until study completion (average period: 4 years)
|
In the group of single-sided deaf children with a cochlear implant, speech perception using only the implant is measured using the Lilliput speech materials.
The sound is streamed directly to the implant to avoid contribution from the normal hearing ear.
Results are reported as speech perception scores (in percentages).
|
At clinical visits after the age of 3, on average 2 times per year, until study completion (average period: 4 years)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Binaural integration and cortical symmetry
Time Frame: One EEG session after the age of 5
|
Using electroencephalography (EEG), the cortical reorganization effect of single-sided deafness is assessed in a subsample of children with compared to without cochlear implant.
Cortical onset responses and bilateral auditory steady-state responses (ASSRs) are used to derive a measure for both cortical symmetry and binaural integration.
|
One EEG session after the age of 5
|
Collaborators and Investigators
Investigators
- Principal Investigator: Astrid van Wieringen, PhD, KU Leuven
- Study Director: Tine Arras, MSc, KU Leuven
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S57318
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Deafness Unilateral
-
Dr. Daniel LeeUniversity of Wisconsin, MadisonTerminatedTotal Unilateral Deafness | Unilateral Partial DeafnessUnited States
-
RWTH Aachen UniversityAdvanced BionicsCompletedDeafness, Bilateral | Deafness Unilateral | Deafness Congenital | Deafness, AcquiredGermany
-
University of North Carolina, Chapel HillMed-El CorporationRecruitingHearing Loss | Congenital Hearing Loss | Hearing Loss, Unilateral | Single Sided Deafness | Unilateral Deafness | Deafness One EarUnited States
-
Oticon MedicalCompletedUnilateral Deafness | Bone Conduction Deafness | Mixed Hearing Loss | Middle Ear DeafnessNetherlands
-
Manohar BanceDalhousie UniversityCompletedUnilateral Hearing Loss | Unilateral Deafness
-
Sonitus Medical IncCompletedHearing Loss | Unilateral Hearing Loss | Total Unilateral DeafnessUnited States
-
Chinese PLA General HospitalRecruitingUnilateral DeafnessChina
-
Sonova AGWestern University, CanadaCompleted
-
Oticon MedicalCompletedUnilateral Deafness | Bone Conduction Deafness | Mixed Hearing Loss | Middle Ear DeafnessNetherlands
-
Washington University School of MedicineChildren's Hospital of Philadelphia; University of Southern California; University... and other collaboratorsRecruitingUnilateral Deafness | Asymmetric Hearing Loss | Single-sided DeafnessUnited States
Clinical Trials on Cochlear implant
-
University of North Carolina, Chapel HillMed-El CorporationCompletedMeniere's Disease | Unilateral Acoustic NeuromaUnited States
-
Nantes University HospitalRecruitingProfound Bilateral Hearing LossFrance
-
CochlearCompletedSingle Sided DeafnessUnited States
-
Western University, CanadaLawson Health Research Institute; Academic Medical Organization of Southwestern... and other collaboratorsRecruiting
-
MED-EL Elektromedizinische Geräte GesmbHRecruitingSensorineural Hearing Loss, BilateralFrance
-
Med-El CorporationTerminatedHearing LossUnited States, Canada
-
CochlearCompleted
-
University of NottinghamNottingham University Hospitals NHS TrustNot yet recruiting
-
University Hospital, AntwerpCochlearRecruitingHearing Loss, Unilateral | Cochlear Implants | Hearing Loss, Sensorineural, Severe | Hearing Loss, Sensorineural, Bilateral | Hearing Loss, Sensorineural, ProfoundBelgium