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Trial registered on ANZCTR


Registration number
ACTRN12613001010785
Ethics application status
Approved
Date submitted
2/09/2013
Date registered
11/09/2013
Date last updated
13/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Cochlear Implant Clinical Care - Evaluation of new methods for sound processor fitting, performance measurement and intra-operative testing in Nucleus Cochlear Implant recipients, compared to existing clinical software
Scientific title
Evaluation of Sound processor fitting, performance measurement and Intra-operative testing in Nucleus Cochlear Implant recipients, compared to existing clinical software.
Secondary ID [1] 283125 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cochlear Implantation 289975 0
Condition category
Condition code
Other 290348 290348 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Ear 290411 290411 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cochlear implant (CI) restores hearing for people with bilateral severe to profound hearing loss. Clinicians use clinical software to
a) Perform intra-operative testing to evaluate the success of the surgery
b) Perform sound processor fitting (also known as MAPping or Programming) to provide optimum performance with the cochlear implant for the recipient
c) Perform performance tests evaluate the benefit of the cochlear implant for the CI recipient.

With the current clinical software, extensive training is required for the clinician to use the software effectively. The study evaluates new versions of clinical software for Sound processor fitting, performance measurement and Intra-operative testing that improves the ease of use for clinicians and CI recipients. The new software has user interface improvements to improve the intuitiveness of the steps to be followed by the clinician making it easier to learn and easy to use.

The study will be conducted with two groups of participants based on whether they are already using an implant (Group 1) or are a candidate for a CI and are scheduled for a surgery (Group 2).
Group 1: Sound processor fitting and performance measurement will be conducted in clinical sessions with participants who have already been implanted with a CI. A usability stage and a performance measurement stage will be conducted. For each stage participants will be randomly selected.

At the usability stage the new software will be used for sound processor fitting, performance measurement with the recipients. The usability of the new software will be assessed in a clinical session typically lasting 2 hours. The participant will not be required to perform tasks outside the clinical session.
At the performance measurement stage the new software will be used for sound processor fitting, with the participants and new programs will be created. The participant's sound processor will be loaded with the programs created by the new software (new program) and also programs created with the current software (current program). The participant will be asked to alternate the use of the new program and the current program on a daily basis for up to 12 weeks and the performance will be assessed in up to 6 clinical sessions. The order of the program used will be randomised and the participant will be blind to the identity of the programs. A daily diary will be used to monitor the participant's adherence to the daily alternation of programs. Each session would last for 2 hours. The study will use a repeated measures design where the recipient will be their own control.

Group 2: The new software will be used for intra-operative testing during CI surgery and the results with the new software will be compared with the current software. No study related activities are required by the participants after the surgery.
Intervention code [1] 287877 0
Other interventions
Comparator / control treatment
Custom Sound suite, the current Clinical software for Sound processor fitting, and Intra-operative testing.
The Custom Sound software is used by the clinician to modify the programs in the cochlear implant recipient's sound processor or to make objective measurements of the implant during cochlear implant surgery.

CNC word test and Austin test, the current tests used for performance measurement . These are recorded speech perception tests materials used to assess the ability of the cochlear implant recipient to comprehend speech.
Control group
Active

Outcomes
Primary outcome [1] 290379 0
Group 1: Speech perception scores for CNC word test and Austin test with new software is not significantly different from the current software.
Timepoint [1] 290379 0
Group 1, performance measurement stage: Within the first fitting session when the new programs are fitted and then evaluated once in 2 weeks for up to 12 weeks if the participant is asked to use the programs at home.
Primary outcome [2] 290381 0
Group 2, Intra-operative testing: The objective test results like NRT thresholds and impedance measurement results with new software and hardware is comparable to the current software.
Timepoint [2] 290381 0
Group 2, Intra-operative testing: During surgery, the set of measurements obtained with the new system will be compared to the the same obtained with the current software.
Secondary outcome [1] 304384 0
Group 1, Usability stage: Ease of use of new software is same or better than current software. The participants will be monitored for their ability to complete the tasks required of them with the training provided without the need for additional help.
Timepoint [1] 304384 0
Group 1, Usability stage: The usability observations with the new system will be compared with the ease of use with the current software in same clinical session when the software is used.

Eligibility
Key inclusion criteria
Implanted or assessed to be suitable for implantation with a commercially available Nucleus implant, resulting in measurable open set speech understanding.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unwillingness or inability of the candidate to comply with all investigational requirements
2. Additional handicaps that would prevent or restrict participation in the audiological evaluations

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Sample size estimation was done based on the standard deviation of error determined from pilot studies.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287876 0
Commercial sector/Industry
Name [1] 287876 0
Cochlear Ltd
Address [1] 287876 0
1 University Ave
Macquarie University
NSW 2109
Country [1] 287876 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cochlear Ltd
Address
1 University Ave
Macquarie University
NSW 2109
Country
Australia
Secondary sponsor category [1] 286603 0
None
Name [1] 286603 0
Address [1] 286603 0
Country [1] 286603 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289819 0
Sydney Local Health District
Ethics committee address [1] 289819 0
Level 11, KGV Building, Missenden Road, CAMPERDOWN NSW 2050
Ethics committee country [1] 289819 0
Australia
Date submitted for ethics approval [1] 289819 0
Approval date [1] 289819 0
16/07/2013
Ethics approval number [1] 289819 0
Protocol No X13-0185

Summary
Brief summary
The study aims at evaluating new methods of sound processor fitting, performance assessments and intra-operative measurements for Nucleus Cochlear Implant recipients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42462 0
Mr Saji Maruthurkkara
Address 42462 0
Cochlear Ltd
1 University Ave
Macquarie University
NSW 2109
Country 42462 0
Australia
Phone 42462 0
+61294253637
Fax 42462 0
Email 42462 0
smaruthurkkara@cochlear.com
Contact person for public queries
Name 42463 0
Mr Saji Maruthurkkara
Address 42463 0
Cochlear Ltd
1 University Ave
Macquarie University
NSW 2109
Country 42463 0
Australia
Phone 42463 0
+61294253637
Fax 42463 0
Email 42463 0
smaruthurkkara@cochlear.com
Contact person for scientific queries
Name 42464 0
Mr Saji Maruthurkkara
Address 42464 0
Cochlear Ltd
1 University Ave
Macquarie University
NSW 2109
Country 42464 0
Australia
Phone 42464 0
+61294253637
Fax 42464 0
Email 42464 0
smaruthurkkara@cochlear.com

No information has been provided regarding IPD availability
Summary results
No Results