Language DevelopmentISLODANCT02853786
Language Environment in Children With Cochlear Implants
A study testing LENA and advice and LENA without advice in people with Language Development, run by University Hospital, Montpellier.
Trial summary
The Language Environment Analysis (LENA) system is a specific tool for the language environment analysis. Children aged from 18 months to 6 years old, with cochlear implants (CIs), wear an electronic device during a day and their language interactions are registered. Read more about this study
- Who is it for?
- Ages 18 months to 6 years
- Conditions the study is for
- Language Development
- What is being tested?
- LENA and advice and LENA without advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 21 Oct 2016to 2 Sep 2020
- Phase
- Interventional
- 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 18 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Congenital profound deaf children
- aged from 18 months to 5 years old 11 months
- with a cochlear implant at least since 6 months
- regular following in speech therapy
Who cannot join
- non-francophone parents
- syndrome (like CHARGE syndrome) or aplasia
- partial insertion of the electrode array
- associated troubles (Autism Spectrum Disorders, mental retardation…)
- visual troubles
- irregular use of the cochlear implant (externe part)
- absence of parental consent
About this study
Official title: Influence of Language Environment in Children With Cochlear Implants
The Language Environment Analysis (LENA) system is a specific tool for the language environment analysis. Children aged from 18 months to 6 years old, with cochlear implants (CIs), wear an electronic device during a day and their language interactions are registered. Then the investigators can analyze with a specific software four different parameters (adult words, conversational turns, child vocalizations and media exposure) and compare them to the language ability of the children assessed by a speech therapist. With the results, the speech therapist can advise the parents how to improve the language environment to help their children with CIs for their language development. Parents are encouraged to follow these advices at home during few months (5 months +/-1 month). Then there is a new registration of the LENA device and another language assessment are performed, to see if there is any improvement. The investigators also measure the family participation.
Hypothesis : There is an influence of the language environment measured by the LENA system on language development in children with cochlear implants.
Read the detailed description
Over 24 months the investigators will recruit 90 patients with cochlear implants (CIs) in 2 centers.
Each patient will follow during 5 months and will have three or five visits according to the arm.
- Conditions
- Language Development
- Being tested
- LENA and advice, LENA without advice
- Keywords
- cochlear implant, language environment, speech therapy assessment, LENA technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LENA and adviceBehavioural
Language recording with the LENA device, with the LENA results, we will advise the parents how to improve the language environment to help their children with CIs for their language development
LENA without adviceOther
Language recording with the LENA device. Regular speech therapy follow blindly the results of LENA
| Study group | Role | What they receive |
|---|---|---|
| LENA and advices | Experimental | With the LENA results, we will advise the parents how to improve the language environment to help their children with CIs for their language development Receives: Behavioral: LENA and advice |
| LENA without advices | Active comparator | Regular speech therapy follow blindly the results of LENA Receives: Other: LENA without advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in language environment measured by LENA system
Measured: At the inclusion, and 5 months after the inclusion
Secondary outcomes (2)
Change in language ability measured by the Grammatical Analysis Of Elicited Language Presentence level (GAEL-P)
Measured: At the inclusion, and 5 months after the inclusion
Change in language ability measured by a vocabulary scale with peabody images (EVIP) (EVIP)
Measured: At the inclusion, and 5 months after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study start21 Oct 2016
- Primary completion2 Sep 2020
- Study completion2 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language DevelopmentStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Necker-Enfants Malades
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853786
- Sponsor's protocol ID
- 9678
- Other IDs
- 2016-A00155-46
- Acronym
- ISLODA
- Status last verified
- Nov 2020
- First submitted
- 7 Jul 2016
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Language Environment in Children With Cochlear Implants
- ClinicalTrials.gov ID
- NCT02853786
- Acronym / sponsor ID
- ISLODA / 9678
- Conditions
- Language Development
- Keywords
- cochlear implant, language environment, speech therapy assessment, LENA technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Hôpital Necker-Enfants Malades
- Study start
- 21 Oct 2016 (actual)
- Primary completion
- 2 Sep 2020 (actual)
- Study completion
- 2 Sep 2020 (actual)
- First posted
- 3 Aug 2016 (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.
The Language Environment Analysis (LENA) system is a specific tool for the language environment analysis. Children aged from 18 months to 6 years old, with cochlear implants (CIs), wear an electronic device during a day and their language interactions are registered. Then the investigators can analyze with a specific software four different parameters (adult words, conversational turns, child vocalizations and media exposure) and compare them to the language ability of the children assessed by a speech therapist. With the results, the speech therapist can advise the parents how to improve the language environment to help their children with CIs for their language development. Parents are encouraged to follow these advices at home during few months (5 months +/-1 month). Then there is a new registration of the LENA device and another language assessment are performed, to see if there is any improvement. The investigators also measure the family participation.
Hypothesis : There is an influence of the language environment measured by the LENA system on language development in children with cochlear implants.
Detailed description
Over 24 months the investigators will recruit 90 patients with cochlear implants (CIs) in 2 centers.
Each patient will follow during 5 months and will have three or five visits according to the arm.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LENA and advices | Experimental | Behavioral: LENA and adviceWith the LENA results, we will advise the parents how to improve the language environment to help their children with CIs for their language development |
| LENA without advices | Active comparator | Other: LENA without adviceRegular speech therapy follow blindly the results of LENA |
Who may qualify
- Ages
- 18 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Congenital profound deaf children
- aged from 18 months to 5 years old 11 months
- with a cochlear implant at least since 6 months
- regular following in speech therapy
Key exclusion criteria (7 listed)
- non-francophone parents
- syndrome (like CHARGE syndrome) or aplasia
- partial insertion of the electrode array
- associated troubles (Autism Spectrum Disorders, mental retardation…)
- visual troubles
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 |
|---|---|---|
| LENA and adviceLanguage recording with the LENA device, with the LENA results, we will advise the parents how to improve the language environment to help their children with CIs for their language development | Behavioural | LENA and advices |
| LENA without adviceLanguage recording with the LENA device. Regular speech therapy follow blindly the results of LENA | Other | LENA without advices |
Primary outcome
Change in language environment measured by LENA system
Time frame: At the inclusion, and 5 months after the inclusion
2 secondary outcomes
Change in language ability measured by the Grammatical Analysis Of Elicited Language Presentence level (GAEL-P)
Time frame: At the inclusion, and 5 months after the inclusion
Change in language ability measured by a vocabulary scale with peabody images (EVIP) (EVIP)
Time frame: At the inclusion, and 5 months after the inclusion
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 18 Nov 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing LENA and advice and LENA without advice in people with Language Development, run by University Hospital, Montpellier.
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 4 inclusion and 7 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 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in language environment measured by LENA system (time frame: At the inclusion, and 5 months after the inclusion). 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 18 Nov 2020.