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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/NCT02746172
Registration number
NCT02746172
Ethics application status
Date submitted
13/04/2016
Date registered
21/04/2016
Date last updated
7/07/2021
Titles & IDs
Public title
Clinical Metrics for Assessing Cochlear Implant Recipient MAPs
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Scientific title
Clinical Metrics for Assessing Audibility, Comfort and Performance of Cochlear Implant Recipient MAPs
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Secondary ID [1]
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CRC5628
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hearing Loss
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Condition category
Condition code
Ear
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Deafness
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Sensitivity of percentage words/ phonemes correct, in detecting MAPs with inaccurate T and C levels in cochlear implant MAPs.
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Assessment method [1]
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Timepoint [1]
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Testing over 12 weeks
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Primary outcome [2]
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Sensitivity of speech reception threshold for numbers and sentences in noise, in detecting MAPs with inaccurate T and C levels in cochlear implant MAPs.
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Assessment method [2]
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Timepoint [2]
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Testing over 12 weeks
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Primary outcome [3]
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Sensitivity of aided hearing thresholds, in detecting MAPs with inaccurate T and C levels in cochlear implant MAPs.
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Assessment method [3]
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Timepoint [3]
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Testing over 12 weeks
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Primary outcome [4]
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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.
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Assessment method [4]
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Timepoint [4]
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Testing over 12 weeks
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Secondary outcome [1]
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Test-retest reliability of in-situ aided audiometry
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Assessment method [1]
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This will be compared to the test-retest reliability of free-field aided audiometry which is within a margin of 10 dB HL.
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Timepoint [1]
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Testing over 6 weeks
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/11/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/10/2017
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Sample size
Target
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Accrual to date
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Final
35
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The HEARing CRC - Melbourne
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Recruitment postcode(s) [1]
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3010 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The Hearing Cooperative Research Centre
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Royal Victoria Eye and Ear Hospital
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Address [1]
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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Cochlear
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02746172
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02746172
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