DeafnessNCT00604474
Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants
A study testing HiResolution Bionic Ear System (Cochlear Implant) in people with Deafness, run by University of California, San Francisco at 1 site in United States.
Trial summary
The primary objective to this study is to describe the auditory development and performance of young deaf children who receive bilateral implants during the first two years following device activation. Read more about this study
- Who is it for?
- Ages 12 to 36 months
- Conditions the study is for
- Deafness
- What is being tested?
- HiResolution Bionic Ear System (Cochlear Implant)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to May 2010
- 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 12 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Profound bilateral hearing loss (PTA>= 90dB HL)
- Have independently elected to undergo bilateral implantation of Advanced Bionics HiResolution Bionic Ear System and meet all the eligibility criteria for this device as described in the product labeling.
- Age at implant: 12-36 months
- Negligible benefit from hearing aids, defined as failure to reach developmentally appropriate milestones on IT-MAIS
- No previous cochlear implant use
- Normal/patent cochlea with no more than a mild "partitioning" defect in either ear
- English as the primary language spoken in the home
- Parental willingness to follow study protocol
Who cannot join
- Deafness secondary to meningitis
- Presence of other conditions that could affect performance on outcome measures or otherwise confound or interfere with study participation of outcomes measures.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
The primary objective to this study is to describe the auditory development and performance of young deaf children who receive bilateral implants during the first two years following device activation.
Read the detailed description
The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of children, ages 12 to 36 months at time of surgery, who receive two implants in the same operation or in two different surgeries with the initial fitting of the devices separated by no more than six months. Acquisition of auditory milestones and speech recognition skills, which underpin the development of spoken language, will be assessed on a battery of outcome measures typically used to quantify implant benefits. In addition, global quality of life and communicative performance will be assessed by parental proxy. Performance will be tracked after 3, 6, 12, 18, and 24 months of device use. The study also will identify variables that may predict the degree of bilateral implant benefit in young children (e.g., age at implant, pre-implant hearing thresholds, communication mode, family socioeconomic status, post-implant aided thresholds, simultaneous vs. staged placement of devices).
- Conditions
- Deafness
- Being tested
- HiResolution Bionic Ear System (Cochlear Implant)
- Keywords
- Deafness, Hearing Loss, Cochlear Implants, Advanced Bionics, HiResolution Bionic Ear System
- Medical subject headings
- Deafness, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HiResolution Bionic Ear System (Cochlear Implant)Device
Subjects are required to have bilateral implantation of the Advanced Bionics HiResolution Bionic Ear System (Cochlear Implant)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Device: HiResolution Bionic Ear System (Cochlear Implant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject performance on speech perception tests
Measured: Two years post device activation
Secondary outcomes (1)
Speech recognition performance at various intervals. Global quality of life and functional communicative performance completed by parental proxy
Measured: 3, 6, 12, 18, and 24 months post device activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: Not sufficient enrollment
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 of California, San FranciscoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence Lustig, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604474
- Sponsor's protocol ID
- 07030750
- Other IDs
- ACR0906
- Status last verified
- Feb 2012
- First submitted
- 17 Jan 2008
- Last updated
- 6 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants
- ClinicalTrials.gov ID
- NCT00604474
- Acronym / sponsor ID
- 07030750
- Conditions
- Deafness
- Keywords
- Deafness, Hearing Loss, Cochlear Implants, Advanced Bionics, HiResolution Bionic Ear System
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not sufficient enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 30 Jan 2008 (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 primary objective to this study is to describe the auditory development and performance of young deaf children who receive bilateral implants during the first two years following device activation.
Detailed description
The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of children, ages 12 to 36 months at time of surgery, who receive two implants in the same operation or in two different surgeries with the initial fitting of the devices separated by no more than six months. Acquisition of auditory milestones and speech recognition skills, which underpin the development of spoken language, will be assessed on a battery of outcome measures typically used to quantify implant benefits. In addition, global quality of life and communicative performance will be assessed by parental proxy. Performance will be tracked after 3, 6, 12, 18, and 24 months of device use. The study also will identify variables that may predict the degree of bilateral implant benefit in young children (e.g., age at implant, pre-implant hearing thresholds, communication mode, family socioeconomic status, post-implant aided thresholds, simultaneous vs. staged placement of devices).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: HiResolution Bionic Ear System (Cochlear Implant) |
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Profound bilateral hearing loss (PTA>= 90dB HL)
- Have independently elected to undergo bilateral implantation of Advanced Bionics HiResolution Bionic Ear System and meet all the eligibility criteria for this device as described in the product labeling.
- Age at implant: 12-36 months
- Negligible benefit from hearing aids, defined as failure to reach developmentally appropriate milestones on IT-MAIS
- No previous cochlear implant use
Key exclusion criteria (2 listed)
- Deafness secondary to meningitis
- Presence of other conditions that could affect performance on outcome measures or otherwise confound or interfere with study participation of outcomes measures.
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 |
|---|---|---|
| HiResolution Bionic Ear System (Cochlear Implant)Subjects are required to have bilateral implantation of the Advanced Bionics HiResolution Bionic Ear System (Cochlear Implant) | Device | 1 |
Primary outcome
Subject performance on speech perception tests
Time frame: Two years post device activation
1 secondary outcome
Speech recognition performance at various intervals. Global quality of life and functional communicative performance completed by parental proxy
Time frame: 3, 6, 12, 18, and 24 months post device activation
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 6 Feb 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.
Lawrence Lustig, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HiResolution Bionic Ear System (Cochlear Implant) in people with Deafness, run by University of California, San Francisco at 1 site in United States.
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 8 inclusion and 2 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 6 Feb 2012. 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 United States. 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 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?
Subject performance on speech perception tests (time frame: Two years post device activation). 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 6 Feb 2012.