DeafnessPhase 3CochleoNCT01499901
Comparison of the Bilateral Sequential and Simultaneous Cochlear Implantation in the Deaf Children
A Phase 3 study testing bilateral cochlear Implantation in sequential and bilateral cochlear Implantation in simultaneous in people with Deafness, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
In France the indication of bilateral cochlear implant (CI) is limited to specific cases. The impact on perception and language of bilateral CI simultaneous versus sequential has to be established before discussing the enlargement of indications. Read more about this study
- Who is it for?
- Ages 8 to 38 months
- Conditions the study is for
- Deafness
- What is being tested?
- bilateral cochlear Implantation in sequential and bilateral cochlear Implantation in simultaneous
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jan 2012
- Phase
- Phase 3
- 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 8 to 38 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Deep bilateral congenital deafness.
- Age at the implantation: from 10 to 40 months, included.
- Criteria for indication of unilateral implantation (those considered by the HAS (2007))
- Deep bilateral deafness
- Threshold prosthetic equal or above 60 dB
- Intelligibility test in open list, below 30%, (to children under 3 years old : raw score in the questionnaire of the M.A.I.S. (72) below 15 with 2 apparatus)
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- No medical nor radiologic contraindication
- Entitled child for welfare (excepted medical state aids)
- French spoken at home
- Agreement firms for the study by the two genitors
Who cannot join
- Neurologic and/or psychiatric known related disorders
- Malformation of the inner ear: the MRI scanners are routine examinations, in case of a cochlear implantation evaluation.
- Progressive or acquired deafness
About this study
Official title: Interest of the Bilateral Cochlear Implantation in the Deep Deaf Children Respect to the Unilateral Implantation - a Randomized Test
In France the indication of bilateral cochlear implant (CI) is limited to specific cases. The impact on perception and language of bilateral CI simultaneous versus sequential has to be established before discussing the enlargement of indications.
Read the detailed description
French multicentric study. 100 children, profound, congenitally deaf, aged between 10 months and 40 months, with indication of unilateral CI will be included. Randomization: 50 sequential at one year CI versus 50 simultaneous bilateral CI, their results compared. Main measures at 12 and 24 months: speech perception in silence and in noise. Other measures: sound localisation, oral language, vestibular impact, quality of life.
- Conditions
- Deafness
- Being tested
- bilateral cochlear Implantation in sequential, bilateral cochlear Implantation in simultaneous
- Keywords
- deafness, unilateral implantation, bilateral, auditory perception
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral cochlear Implantation in sequentialProcedure or surgery
bilateral cochlear Implantation in sequential
bilateral cochlear Implantation in simultaneousProcedure or surgery
bilateral cochlear Implantation in simultaneous
| Study group | Role | What they receive |
|---|---|---|
| sequential | Experimental | implantation bilateral sequential Receives: Procedure: bilateral cochlear Implantation in sequential |
| simultaneous | Experimental | implantation bilateral simultaneous Receives: Procedure: bilateral cochlear Implantation in simultaneous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the score of perception of words in open list
Measurement of the score of perception of words in open list in the noise 12 and 24 months after the implantation
Measured: 12 months after the implantation
Secondary outcomes (5)
Measurement of the capability of localization right/left
Measurement of the capability of localization right/left
Measured: 12 and 24 months after the implantation
Measurement of the level of comprehension and production
Measurement of the level of comprehension and production after 24 months after the implantation
Measured: 24 months after the implantation
Evaluation of the medical monitoring about the materiovigilance and the eventual complications
Evaluation of the medical monitoring about the materiovigilance and the eventual complications
Measured: During all the duration of the study
Measurement of the vestibulometry and of the children's psychomotor development
Measurement of the vestibulometry and of the children's psychomotor development
Measured: 12 and 24 months after the implantation
Analysis of the parent questionnaires of the quality of life
Analysis of the parent questionnaires of the quality of life
Measured: 12 and 24 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Recommendations of HAS have changed, the study is now useless
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 Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie Loundon, MD, MD-PhD, Principal investigator, Assistance Publique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499901
- Sponsor's protocol ID
- P091204
- Other IDs
- HAO 09048
- Acronym
- Cochleo
- Status last verified
- Nov 2012
- First submitted
- 6 Dec 2011
- Last updated
- 19 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Bilateral Cochlear Implantation in the Deep Deaf Children Respect to the Unilateral Implantation - a Randomized Test
- ClinicalTrials.gov ID
- NCT01499901
- Acronym / sponsor ID
- Cochleo / P091204
- Conditions
- Deafness
- Keywords
- deafness, unilateral implantation, bilateral, auditory perception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recommendations of HAS have changed, the study is now useless
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 Dec 2011 (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.
In France the indication of bilateral cochlear implant (CI) is limited to specific cases. The impact on perception and language of bilateral CI simultaneous versus sequential has to be established before discussing the enlargement of indications.
Detailed description
French multicentric study. 100 children, profound, congenitally deaf, aged between 10 months and 40 months, with indication of unilateral CI will be included. Randomization: 50 sequential at one year CI versus 50 simultaneous bilateral CI, their results compared. Main measures at 12 and 24 months: speech perception in silence and in noise. Other measures: sound localisation, oral language, vestibular impact, quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sequential | Experimental | Procedure: bilateral cochlear Implantation in sequentialimplantation bilateral sequential |
| simultaneous | Experimental | Procedure: bilateral cochlear Implantation in simultaneousimplantation bilateral simultaneous |
Who may qualify
- Ages
- 8 to 38 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Deep bilateral congenital deafness.
- Age at the implantation: from 10 to 40 months, included.
- Criteria for indication of unilateral implantation (those considered by the HAS (2007))
- Deep bilateral deafness
- Threshold prosthetic equal or above 60 dB
Key exclusion criteria (3 listed)
- Neurologic and/or psychiatric known related disorders
- Malformation of the inner ear: the MRI scanners are routine examinations, in case of a cochlear implantation evaluation.
- Progressive or acquired deafness
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 |
|---|---|---|
| bilateral cochlear Implantation in sequentialbilateral cochlear Implantation in sequential | Procedure or surgery | sequential |
| bilateral cochlear Implantation in simultaneousbilateral cochlear Implantation in simultaneous | Procedure or surgery | simultaneous |
Primary outcome
Measurement of the score of perception of words in open list
Time frame: 12 months after the implantation
Measurement of the score of perception of words in open list in the noise 12 and 24 months after the implantation
5 secondary outcomes
Measurement of the capability of localization right/left
Time frame: 12 and 24 months after the implantation
Measurement of the level of comprehension and production
Time frame: 24 months after the implantation
Evaluation of the medical monitoring about the materiovigilance and the eventual complications
Time frame: During all the duration of the study
Measurement of the vestibulometry and of the children's psychomotor development
Time frame: 12 and 24 months after the implantation
Analysis of the parent questionnaires of the quality of life
Time frame: 12 and 24 months after implantation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2012.
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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.
Nathalie Loundon, MD, MD-PhD principal investigator
Assistance Publique
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bilateral cochlear Implantation in sequential and bilateral cochlear Implantation in simultaneous in people with Deafness, run by Assistance Publique - Hôpitaux de Paris.
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 10 inclusion and 3 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: withdrawn, as of the sponsor's last update on 19 Nov 2012. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Measurement of the score of perception of words in open list (time frame: 12 months after the implantation). 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 19 Nov 2012.