Hearing LossNCT01072409
Clinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System
A study testing Nucleus 5 Cochlear implant and Cochlear implantation in people with Hearing Loss, run by Cochlear at 1 site in United States.
Trial summary
To evaluate the performance of the Nucleus 5 Cochlear Implant System. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Nucleus 5 Cochlear implant and Cochlear implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Nov 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eighteen years of age or older at the time of the study.
- Postlinguistic onset of bilateral severe-to-profound sensorineural hearing loss
- Bilateral severe-to-profound hearing loss that meets current cochlear implant criteria (<50% open-set sentence recognition in quiet scores in the ear to be implanted and <60% in the best-aided condition)
- English spoken as the primary language.
- Willingness to participate in and to comply with all requirements of the study
- Subject may receive bilateral simultaneous cochlear implants.
Who cannot join
- Previous cochlear implant experience
- Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age).
- Ossification, absence of cochlear development or any other cochlear anomaly that might prevent complete insertion of the electrode array.
- Normal hearing in one or both ears.
- Hearing loss of neural or central origin (e.g., deafness due to lesions on the acoustic nerve or central auditory pathway).
- Active middle-ear infection.
- Unwillingness and/or inability of the candidate to comply with all investigational requirements including, but not limited to, study protocol and surgical procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Nucleus 5 Cochlear Implant System
To evaluate the performance of the Nucleus 5 Cochlear Implant System.
Read the detailed description
Performance outcomes of newly implanted adult recipients using the Nucleus 5 Cochlear Implant System.
- Conditions
- Hearing Loss
- Being tested
- Nucleus 5 Cochlear implant, Cochlear implantation
- Keywords
- Speech perception ability in the CI alone condition
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nucleus 5 Cochlear implantDevice
Cochlear implant surgery
Cochlear implantationDevice
Implantation
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Single arm design Receives: Device: Nucleus 5 Cochlear implant; Device: Cochlear implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
CNC Monosyllabic Word Performance - Treated Ear
CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by CochlearThe 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teresa Zwolan, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072409
- Sponsor's protocol ID
- CAM5255
- Status last verified
- Sep 2014
- First submitted
- 18 Feb 2010
- Last updated
- 27 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Nucleus 5 Cochlear Implant System
- ClinicalTrials.gov ID
- NCT01072409
- Acronym / sponsor ID
- CAM5255
- Conditions
- Hearing Loss
- Keywords
- Speech perception ability in the CI alone condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 22 Feb 2010 (estimated)
- Results
- Posted 25 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the performance of the Nucleus 5 Cochlear Implant System.
Detailed description
Performance outcomes of newly implanted adult recipients using the Nucleus 5 Cochlear Implant System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: Nucleus 5 Cochlear implant, Device: Cochlear implantationSingle arm design |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eighteen years of age or older at the time of the study.
- Postlinguistic onset of bilateral severe-to-profound sensorineural hearing loss
- Bilateral severe-to-profound hearing loss that meets current cochlear implant criteria (<50% open-set sentence recognition in quiet scores in the ear to be implanted and <60% in the best-aided condition)
- English spoken as the primary language.
- Willingness to participate in and to comply with all requirements of the study
Key exclusion criteria (7 listed)
- Previous cochlear implant experience
- Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age).
- Ossification, absence of cochlear development or any other cochlear anomaly that might prevent complete insertion of the electrode array.
- Normal hearing in one or both ears.
- Hearing loss of neural or central origin (e.g., deafness due to lesions on the acoustic nerve or central auditory pathway).
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 |
|---|---|---|
| Nucleus 5 Cochlear implantCochlear implant surgery | Device | Single Arm |
| Cochlear implantationImplantation | Device | Single Arm |
Primary outcome
CNC Monosyllabic Word Performance - Treated Ear
Time frame: 12 months
CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Teresa Zwolan, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nucleus 5 Cochlear implant and Cochlear implantation in people with Hearing Loss, run by Cochlear 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 6 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 27 Oct 2016. 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?
Yes. Results are posted in the registry (first posted 25 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
CNC Monosyllabic Word Performance - Treated Ear (time frame: 12 months). 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 27 Oct 2016.