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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
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
Trial website
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
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01800929