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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02746172




Registration number
NCT02746172
Ethics application status
Date submitted
13/04/2016
Date registered
21/04/2016
Date last updated
21/04/2016

Titles & IDs
Public title
Clinical Metrics for Assessing Cochlear Implant Recipient MAPs
Scientific title
Clinical Metrics for Assessing Audibility, Comfort and Performance of Cochlear Implant Recipient MAPs
Secondary ID [1] 0 0
CRC5628
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - Cochlear implant with in-situ audiometry

Experimental: Cochlear Implant Recipients - cochlear implant recipients

No Intervention: Normal Hearing Volunteers - Normal hearing volunteers


Treatment: Devices: Cochlear implant with in-situ audiometry


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sensitivity of percentage words/ phonemes correct, in detecting MAPs with inaccurate T and C levels in cochlear implant MAPs.
Timepoint [1] 0 0
Testing over 12 weeks
Primary outcome [2] 0 0
Sensitivity of speech reception threshold for numbers and sentences in noise, in detecting MAPs with inaccurate T and C levels in cochlear implant MAPs.
Timepoint [2] 0 0
Testing over 12 weeks
Primary outcome [3] 0 0
Sensitivity of aided hearing thresholds, in detecting MAPs with inaccurate T and C levels in cochlear implant MAPs.
Timepoint [3] 0 0
Testing over 12 weeks
Primary outcome [4] 0 0
Sensitivity of loudness ratings for narrow band noise presented at different frequencies and levels, in detecting MAPs with inaccurate T and C levels in cochlear implant MAPs.
Timepoint [4] 0 0
Testing over 12 weeks
Secondary outcome [1] 0 0
Test-retest reliability of in-situ aided audiometry - This will be compared to the test-retest reliability of free-field aided audiometry which is within a margin of 10 dB HL.
Timepoint [1] 0 0
Testing over 6 weeks

Eligibility
Key inclusion criteria
1. Adult (>18 years) cochlear implant recipients

2. Implanted with the CI500, CI24RE and Nucleus 24 Series and CI422 cochlear implants.

3. User of commercially available Freedom, CP810 or CP900 series sound processor

4. User of the ACE strategy

5. At least 3 months experience with the cochlear implant

6. Fluent speaker in the language used to assess speech perception performance

7. Willingness to participate in and to comply with all requirements of the protocol
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Additional handicaps that would prevent participation in evaluations

2. Unrealistic expectations on the part of the subject, regarding the possible benefits,
risks and limitations that are inherent to the procedure and investigational device

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
Parallel
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
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)
VIC
Recruitment hospital [1] 0 0
The HEARing CRC - Melbourne
Recruitment postcode(s) [1] 0 0
3010 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Hearing Cooperative Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Victoria Eye and Ear Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Cochlear
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The aim of this research is to investigate the potential use of specific metrics in assessing
the quality and optimising an individual's cochlear implant fitting. Assessment of the
sensitivity and specificity of specific metrics that are potential predictors of inaccurate
T-levels and C-levels is important to determining best methods for streamlined high quality
fitting, providing the potential for feedback to the individual and clinic, as well as
automated adjustments for optimisation. Ultimately the objective is to increase clinical
capacity for managing both the installed base and new candidates for cochlear implantation.
Trial website
https://clinicaltrials.gov/show/NCT02746172
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, MBA
Address 0 0
Country 0 0
Phone 0 0
+613 9035 5346
Fax 0 0
Email 0 0
rcowan@hearingcrc.org
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02746172