Transplants and ImplantsNCT01800929
Evaluation of Performance and Usability of N6 in the Paediatric Population
A study testing N6 in people with Transplants and Implants and Hearing Loss, run by Cochlear, Asia Pacific at 4 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the performance and usability of the N6 system in children with the N5 system. Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Transplants and Implants, Hearing Loss
- What is being tested?
- N6
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Nov 2012to Jun 2013
- 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 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 5-14 years, currently using N5
- Minimum speech perception ability in noise of 30% at +10 decibels (dB) signal-to-noise ratio (SNR).
- Minimum of 2 years cochlear implant (CI) experience, including at least 6 months experience with their current processor
- Excellent verbal reporters
- Excellent record of attending clinical appointments.
- Attend a regular school,
- English 1st language.
- Excellent record of compliance with habilitation tasks.
Who cannot join
- Cognitive impairment, or other significant impairment that would impact on their ability to undertake task requirements
- Inability to attend study appointments.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Australia3 sites, 2 recruiting
- Recruiting
Hear and Say Centre
Brisbane, Queensland, 4066
Jane McGovern, M AUd St, +61738702221, jane@hearandsay.com.au
Gabriella Constantinescu, PhD, +61738702221, gabriella@hearandsaycentre.com.au
- Recruiting
Melbourne Cochlear Implant Clinic
Melbourne, Victoria, 3002
Michelle Moran, M Aud, +61399298624
Alex Rousset, M Aud, +61399298624
- Active, not recruiting
The Shepherd Centre
Sydney, New South Wales, 2008
New Zealand1 site, 1 recruiting
- Recruiting
The Hearing House
Auckland
Leigh Martelli, M Aud, +6495792333, leigh@hearinghouse.co.nz
Janet Digby, +6495792333, janet@levare.co.nz
About this study
The purpose of this study is to evaluate the performance and usability of the N6 system in children with the N5 system.
Read the detailed description
This study will evaluate the user benefits of the N6 system in the paediatric population currently equipped with N5. The performance and usability of both systems will be evaluated and compared. The performance of the N6 is expected to be at least equivalent to the N5.
Outcome measures:
- City University of New York (CUNY) Sentence Test in quiet and noise
- Consonant-Nucleus-Consonant (CNC) words in quiet
- in-house designed Usability questionnaires of the N6 system (information to be used internally)
- PEACH, TEACH and SELF questionnaires - developed by Ching \& Hill (2007). PEACH - The Parents' Evaluation of Aural/oral performance of Children TEACH - The Teachers' Evaluation of Aural/oral performance of Children for teachers SELF - The Child's Self evaluation of aural/oral performance.
Speech perception tests will be administered at baseline, then again three times, two weeks apart with the N6 processor - i.e. week 0, week 2, week 4 \& week 6. Total time: 2 months.
Questionnaires will also be given at the same time points, to get baseline information, as well as N6 information
- Conditions
- Transplants and Implants, Hearing Loss
- Being tested
- N6
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N6Device
Children with N5 will be upgraded to the N6 for a period of up to 2 months to evaluate.
| Study group | Role | What they receive |
|---|---|---|
| N6 | Experimental | The N6 system comprises an investigational sound processor, remote assistant and fitting software Receives: Device: N6 |
| N5 | Active comparator | The current commercially-available cochlear implant system Performance of N5 will be compared to performance with N6 using a within-subject design. Receives: Device: N6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group usability performance data for N6 versus N5
The investigational sound processor, remote assistant and fitting software will be compared to the existing implant system on measures of speech perception and usability in a take-home study.
Measured: Nov 2012-June 2013
Secondary outcomes (5)
speech recognition scores in quiet and noise between the two processors
The CUNY sentences and CNC word lists will be administered in quiet and noise.
Measured: Nov 2012-June 2013
Useability questionnaire on the different sound processing features
An in house questionnaire has been developed where the parent is asked to rank various features of the device, and its usability on a 5-point Likert Scale
Measured: Nov 2012-June 2013
Subjective feedback on performance as well as patient preference between the 2 processors
The PEACH, TEACH and SELF (Ching \& Hill, 2007) will be used to collect this information from the parent, teacher and child. These questionnaires have been used in many previous studies.
In addition, any verbal feedback provided by recipients will be noted on CRFs.
Measured: Nov 2012-June 2013
Evaluate the usability of the two systems in a group of children, their carers and their teachers
The information from the above questionnaires will be used to collectively compare the usability of the child's current processor and the N6 processor.
Measured: Nov 2012-June 2013
Clinical recommendations for fitting paediatric recipients with the new processor
Measured: Nov 2012-June 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplants and ImplantsStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cochlear, Asia Pacific
- Sponsor type
- University, hospital or other
- Collaborators
- The HEARing Co-operative Research Centre, Melbourne, Melbourne Cochlear Implant Clinic, Melbourne, The Shepherd Centre, Sydney, Hear and Say Centre, The Hearing House, Auckland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800929
- Sponsor's protocol ID
- CAP5433
- Status last verified
- Feb 2013
- First submitted
- 27 Aug 2012
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Performance and Usability of N6 in the Paediatric Population
- ClinicalTrials.gov ID
- NCT01800929
- Acronym / sponsor ID
- CAP5433
- Conditions
- Transplants and Implants, Hearing Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cochlear, Asia PacificUniversity, hospital or other
- Collaborators
- The HEARing Co-operative Research Centre, Melbourne, Melbourne Cochlear Implant Clinic, Melbourne, The Shepherd Centre, Sydney, Hear and Say Centre, The Hearing House, Auckland
- Study start
- Nov 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 28 Feb 2013 (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 purpose of this study is to evaluate the performance and usability of the N6 system in children with the N5 system.
Detailed description
This study will evaluate the user benefits of the N6 system in the paediatric population currently equipped with N5. The performance and usability of both systems will be evaluated and compared. The performance of the N6 is expected to be at least equivalent to the N5.
Outcome measures:
- City University of New York (CUNY) Sentence Test in quiet and noise
- Consonant-Nucleus-Consonant (CNC) words in quiet
- in-house designed Usability questionnaires of the N6 system (information to be used internally)
- PEACH, TEACH and SELF questionnaires - developed by Ching \& Hill (2007). PEACH - The Parents' Evaluation of Aural/oral performance of Children TEACH - The Teachers' Evaluation of Aural/oral performance of Children for teachers SELF - The Child's Self evaluation of aural/oral performance.
Speech perception tests will be administered at baseline, then again three times, two weeks apart with the N6 processor - i.e. week 0, week 2, week 4 \& week 6. Total time: 2 months.
Questionnaires will also be given at the same time points, to get baseline information, as well as N6 information
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N6 | Experimental | Device: N6The N6 system comprises an investigational sound processor, remote assistant and fitting software |
| N5 | Active comparator | Device: N6The current commercially-available cochlear implant system Performance of N5 will be compared to performance with N6 using a within-subject design. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age 5-14 years, currently using N5
- Minimum speech perception ability in noise of 30% at +10 decibels (dB) signal-to-noise ratio (SNR).
- Minimum of 2 years cochlear implant (CI) experience, including at least 6 months experience with their current processor
- Excellent verbal reporters
- Excellent record of attending clinical appointments.
Key exclusion criteria (2 listed)
- Cognitive impairment, or other significant impairment that would impact on their ability to undertake task requirements
- Inability to attend study appointments.
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 |
|---|---|---|
| N6Children with N5 will be upgraded to the N6 for a period of up to 2 months to evaluate. | Device | N5, N6 |
Primary outcome
Group usability performance data for N6 versus N5
Time frame: Nov 2012-June 2013
The investigational sound processor, remote assistant and fitting software will be compared to the existing implant system on measures of speech perception and usability in a take-home study.
5 secondary outcomes
speech recognition scores in quiet and noise between the two processors
Time frame: Nov 2012-June 2013
Useability questionnaire on the different sound processing features
Time frame: Nov 2012-June 2013
Subjective feedback on performance as well as patient preference between the 2 processors
Time frame: Nov 2012-June 2013
Evaluate the usability of the two systems in a group of children, their carers and their teachers
Time frame: Nov 2012-June 2013
Clinical recommendations for fitting paediatric recipients with the new processor
Time frame: Nov 2012-June 2013
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2013.
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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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N6 in people with Transplants and Implants and Hearing Loss, run by Cochlear, Asia Pacific at 4 sites in 2 countries.
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: status not confirmed, as of the sponsor's last update on 1 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, New Zealand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Cowan, PhD (+61294286555, r.cowan@unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group usability performance data for N6 versus N5 (time frame: Nov 2012-June 2013). 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 1 Mar 2013.