DeafnessDECCODESNCT02539901
Development of a Deaf Child With a Cochlear Implant.
An observational study of Deafness, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Cochlear implantation enables profoundly deaf children to acquire speech and develop their understanding of spoken language. However, there are significant interindividual differences in the results obtained with the implant. Read more about this study
- Who is it for?
- Ages 12 months to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Deafness
- What is being tested?
- Evaluation of the detection of non-linguistic sounds, Free hearing test categorization and Early Social Communication Scale (ECSP)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Oct 2014
- Phase
- Observational
- 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 12 months to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Young patients consulting in the Unit of Pediatric Cochlear Implantation, Hospital-University Centre of Toulouse. The normal hearing participants will be recruited by posters, produced in various places childcare (crèches, schools) or pediatric services Purpan hospital.
Who may be able to join
- To achieve this study, two cohorts will be formed:
- A cohort of deaf children aged 12 to 30 months:
- Be reached a bilateral profound sensorineural hearing loss (greater than 90 dB hearing loss, as classified by the International Bureau for Audiophonology, 1997);
- Raise a cochlear implant;
- Being affiliated to a social security scheme.
- Consent representatives of parental authority (or at least one of the two)
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- A cohort of deaf children from 6 to 9 years:
- Be reached a bilateral profound sensorineural hearing loss;
- Be holder of a cochlear implant for at least 3 years;
- Consent representatives of parental authority (or at least one of the two).
- A group of normal hearing typically developing children:
- this group will provide benchmarks for perception tests. It consists of two sub-groups:
- Children with normal hearing typically developing 12 to 30 months; children whith a general, linguistic and normal psychomotor evaluated on the basis of prior clinical examination at baseline and on the compilation of their health record. They must not present psychomotor retardation or language.
- Children with normal hearing in typical development 6 to 9 years.
- Be matched in age and sex with deaf children (a pairing with a child on the criteria defined above). In terms of developmental age, we can consider as having comparable in terms of age development of children with:
- +/- 6 months for the population of children 6 to 9 years
- +/- 1 month for the population of children 12 to 30 months.
- Have a typical development, evaluated by a grade level for their age;
- Consent representatives of parental authority (or at least one of the two).
Who cannot join
- Will be excluded from our study subjects where there is an inability to meet the tests, either in situations:
- Impossible to understand instructions
- Blindness
- Impossible to meet the tests
- Multihandicap
- A legal impossibility. Furthermore, children will be excluded for which there is a refusal on the part of the parents or of the child to participate in the study (for children old enough to express their opinion).
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Purpan - Pavillon Dieulafoy - Service ORL (ENT services)
Toulouse, Haute-Garonne, 31059
About this study
Official title: Cognitive and Communicative Development Description of Deaf Child With a Cochlear Implant.
Cochlear implantation enables profoundly deaf children to acquire speech and develop their understanding of spoken language. However, there are significant interindividual differences in the results obtained with the implant. Given the lack of theoretical knowledge on acoustic predictors, cognitive and language to obtain optimum speech recognition with cochlear implants associated with a good communicative and language development of deaf children, the investigators intend to achieve a preliminary longitudinal study aimed to describe the cognitive, communicative and perceptive implanted deaf children.
The main objective of our study is to describe the cognitive and communicative development of deaf children implanted from the pre-implant assessment to 18 months post-implantation, by addressing the following aspects:
- The psychomotor and cognitive development assessed using the Brunet-Lézine test;
- The development of preverbal communication, evaluated using the Early Social Communication Scale.
- Conditions
- Deafness
- Being tested
- Evaluation of the detection of non-linguistic sounds, Free hearing test categorization, Early Social Communication Scale (ECSP), psychomotor infancy development scale, NEPSY (two domains: "memory and learning" and "attention and executive functions").
- Keywords
- cochlear implant, Developmental Psychology, cognitive development, communicative development, perceptual development, deaf child
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the detection of non-linguistic soundsBehavioural
Evaluation of the detection of non-linguistic sounds (sound room)
Free hearing test categorizationBehavioural
Free hearing test categorization evaluation
Early Social Communication Scale (ECSP)Behavioural
Early Social Communication Scale (ECSP) evaluation
psychomotor infancy development scaleBehavioural
Also called Lézine Brunet-Revised scale
NEPSY (two domains: "memory and learning" and "attention and executive functions").Behavioural
NEPSY evaluation
| Study group | Role | What they receive |
|---|---|---|
| 12-30 months-old deaf children | Children with deafness of bilateral deep perception had : Evaluation of the detection of non-linguistic sounds, Early Social Communication Scale (ECSP) and psychomotor infancy development scale or Lézine Brunet-Revised scale Receives: Behavioral: Evaluation of the detection of non-linguistic sounds; Behavioral: Early Social Communication Scale (ECSP); Behavioral: psychomotor infancy development scale | |
| 6-9 years-old deaf children | Free hearing test categorization and NEPSY (two domains: "memory and learning" and "attention and executive functions") in 6-9 years-old deaf child cohort with deafness of bilateral deep perception and carrying a cochlear implant Receives: Behavioral: Free hearing test categorization; Behavioral: NEPSY (two domains: "memory and learning" and "attention and executive functions"). | |
| 12-30 months-old normal hearing children | Evaluation of the detection of non-linguistic sounds in 12-30 months-old normal hearing child cohort Receives: Behavioral: Evaluation of the detection of non-linguistic sounds | |
| 6-9 years-old normal hearing children | 'Free hearing test categorization' in 6-9 years-old normal hearing child cohort Receives: Behavioral: Free hearing test categorization |
What is being measured
The primary outcome is the main question the study is designed to answer.
screening and diagnosis of global developmental delays in young children
Measured: inclusion
evaluation of variation pre-linguistic communication and lexicon emergence
Measured: inclusion, 6 months, 12 months and 18 months
Secondary outcomes (2)
Non-linguistic variation of sounds Detection Test
Measured: inclusion, 6 months, 12 months and 18 months
Neuropsychological assessment of child development variation
Measured: inclusion, 6 months, 12 months and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startOct 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeafnessStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier DEGUINE, MD, PhD, Principal investigator, Service ORL - Hôpital Purpan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539901
- Sponsor's protocol ID
- 11 227 02
- Other IDs
- 2011-A01058-33
- Acronym
- DECCODES
- Status last verified
- Aug 2015
- First submitted
- 18 Aug 2015
- Last updated
- 3 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Communicative Development Description of Deaf Child With a Cochlear Implant.
- ClinicalTrials.gov ID
- NCT02539901
- Acronym / sponsor ID
- DECCODES / 11 227 02
- Conditions
- Deafness
- Keywords
- cochlear implant, Developmental Psychology, cognitive development, communicative development, perceptual development, deaf child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 3 Sep 2015 (estimated)
- 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.
Cochlear implantation enables profoundly deaf children to acquire speech and develop their understanding of spoken language. However, there are significant interindividual differences in the results obtained with the implant. Given the lack of theoretical knowledge on acoustic predictors, cognitive and language to obtain optimum speech recognition with cochlear implants associated with a good communicative and language development of deaf children, the investigators intend to achieve a preliminary longitudinal study aimed to describe the cognitive, communicative and perceptive implanted deaf children.
The main objective of our study is to describe the cognitive and communicative development of deaf children implanted from the pre-implant assessment to 18 months post-implantation, by addressing the following aspects:
- The psychomotor and cognitive development assessed using the Brunet-Lézine test;
- The development of preverbal communication, evaluated using the Early Social Communication Scale.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 12-30 months-old deaf children | – | Behavioral: Evaluation of the detection of non-linguistic sounds, Behavioral: Early Social Communication Scale (ECSP), Behavioral: psychomotor infancy development scaleChildren with deafness of bilateral deep perception had : Evaluation of the detection of non-linguistic sounds, Early Social Communication Scale (ECSP) and psychomotor infancy development scale or Lézine Brunet-Revised scale |
| 6-9 years-old deaf children | – | Behavioral: Free hearing test categorization, Behavioral: NEPSY (two domains: "memory and learning" and "attention and executive functions").Free hearing test categorization and NEPSY (two domains: "memory and learning" and "attention and executive functions") in 6-9 years-old deaf child cohort with deafness of bilateral deep perception and carrying a cochlear implant |
| 12-30 months-old normal hearing children | – | Behavioral: Evaluation of the detection of non-linguistic soundsEvaluation of the detection of non-linguistic sounds in 12-30 months-old normal hearing child cohort |
| 6-9 years-old normal hearing children | – | Behavioral: Free hearing test categorization'Free hearing test categorization' in 6-9 years-old normal hearing child cohort |
Who may qualify
- Ages
- 12 months to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Young patients consulting in the Unit of Pediatric Cochlear Implantation, Hospital-University Centre of Toulouse. The normal hearing participants will be recruited by posters, produced in various places childcare (crèches, schools) or pediatric services Purpan hospital.
Key inclusion criteria (19 listed)
- A cohort of deaf children aged 12 to 30 months:
- A cohort of deaf children from 6 to 9 years:
- A group of normal hearing typically developing children:
- Children with normal hearing typically developing 12 to 30 months; children whith a general, linguistic and normal psychomotor evaluated on the basis of prior clinical examination at baseline and on the compilation of their health record. They must not present psychomotor retardation or language.
- Children with normal hearing in typical development 6 to 9 years.
Key exclusion criteria (6 listed)
- Will be excluded from our study subjects where there is an inability to meet the tests, either in situations:
- Impossible to understand instructions
- Blindness
- Impossible to meet the tests
- Multihandicap
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 |
|---|---|---|
| Evaluation of the detection of non-linguistic soundsEvaluation of the detection of non-linguistic sounds (sound room) | Behavioural | 12-30 months-old deaf children, 12-30 months-old normal hearing children |
| Free hearing test categorizationFree hearing test categorization evaluation | Behavioural | 6-9 years-old deaf children, 6-9 years-old normal hearing children |
| Early Social Communication Scale (ECSP)Early Social Communication Scale (ECSP) evaluation | Behavioural | 12-30 months-old deaf children |
| psychomotor infancy development scaleAlso: Lézine Brunet-Revised scale | Behavioural | 12-30 months-old deaf children |
| NEPSY (two domains: "memory and learning" and "attention and executive functions").NEPSY evaluation | Behavioural | 6-9 years-old deaf children |
Primary outcome
screening and diagnosis of global developmental delays in young children
Time frame: inclusion
evaluation of variation pre-linguistic communication and lexicon emergence
Time frame: inclusion, 6 months, 12 months and 18 months
2 secondary outcomes
Non-linguistic variation of sounds Detection Test
Time frame: inclusion, 6 months, 12 months and 18 months
Neuropsychological assessment of child development variation
Time frame: inclusion, 6 months, 12 months and 18 months
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 3 Sep 2015.
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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.
Olivier DEGUINE, MD, PhD principal investigator
Service ORL - Hôpital Purpan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deafness, run by University Hospital, Toulouse at 1 site in France.
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 19 inclusion and 6 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 3 Sep 2015. 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 France. 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?
screening and diagnosis of global developmental delays in young children (time frame: inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2015.