Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01800929




Registration number
NCT01800929
Ethics application status
Date submitted
27/08/2012
Date registered
28/02/2013
Date last updated
1/03/2013

Titles & IDs
Public title
Evaluation of Performance and Usability of N6 in the Paediatric Population
Scientific title
Evaluation of Performance and Usability of N6 in the Paediatric Population
Secondary ID [1] 0 0
CAP5433
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transplants and Implants 0 0
Hearing Loss 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - N6

Experimental: N6 - The N6 system comprises an investigational sound processor, remote assistant and fitting software

Active Comparator: N5 - The current commercially-available cochlear implant system Performance of N5 will be compared to performance with N6 using a within-subject design.


Treatment: Devices: N6
Children with N5 will be upgraded to the N6 for a period of up to 2 months to evaluate.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Group usability performance data for N6 versus N5
Timepoint [1] 0 0
Nov 2012-June 2013
Secondary outcome [1] 0 0
speech recognition scores in quiet and noise between the two processors
Timepoint [1] 0 0
Nov 2012-June 2013
Secondary outcome [2] 0 0
Useability questionnaire on the different sound processing features
Timepoint [2] 0 0
Nov 2012-June 2013
Secondary outcome [3] 0 0
Subjective feedback on performance as well as patient preference between the 2 processors
Timepoint [3] 0 0
Nov 2012-June 2013
Secondary outcome [4] 0 0
Evaluate the usability of the two systems in a group of children, their carers and their teachers
Timepoint [4] 0 0
Nov 2012-June 2013
Secondary outcome [5] 0 0
Clinical recommendations for fitting paediatric recipients with the new processor
Timepoint [5] 0 0
Nov 2012-June 2013

Eligibility
Key inclusion criteria
- 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.
Minimum age
5 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Cognitive impairment, or other significant impairment that would impact on their
ability to undertake task requirements

- Inability to attend study appointments.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2013
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
The Shepherd Centre - Sydney
Recruitment hospital [2] 0 0
Hear and Say Centre - Brisbane
Recruitment hospital [3] 0 0
Melbourne Cochlear Implant Clinic - Melbourne
Recruitment postcode(s) [1] 0 0
2008 - Sydney
Recruitment postcode(s) [2] 0 0
4066 - Brisbane
Recruitment postcode(s) [3] 0 0
3002 - Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Cochlear, Asia Pacific
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The HEARing Co-operative Research Centre, Melbourne
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Melbourne Cochlear Implant Clinic, Melbourne
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
The Shepherd Centre, Sydney
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Hear and Say Centre
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
The Hearing House, Auckland
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the performance and usability of the N6 system in
children with the N5 system.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01800929
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Robert Cowan, PhD
Address 0 0
Country 0 0
Phone 0 0
+61294286555
Fax 0 0
Email 0 0
r.cowan@unimelb.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01800929