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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/NCT02765386




Registration number
NCT02765386
Ethics application status
Date submitted
14/04/2016
Date registered
6/05/2016
Date last updated
6/07/2021

Titles & IDs
Public title
Optimisation of Hybrid Fittings for Cochlear Implant Recipients
Scientific title
Optimisation of Hybrid Fittings for Newly Implanted Cochlear Implant Recipients
Secondary ID [1] 0 0
CRC5610
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
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Hybrid fittings for cochlear implant recipients

Experimental: Cochlear Implant Recipients - Newly implanted cochlear implant recipients with post-implantation acoustic hearing.


Treatment: Devices: Hybrid fittings for cochlear implant recipients
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Speech, Spatial and Qualities of Hearing (SSQ) scale
Timepoint [1] 0 0
Testing at 18, 19, 22 and 25 weeks post-activation of cochlear implant
Primary outcome [2] 0 0
Word recognition scores in quiet
Timepoint [2] 0 0
Testing at 12, 15, 18, 19, 22 and 25 weeks post-activation of cochlear implant
Primary outcome [3] 0 0
Speech recognition in noise
Timepoint [3] 0 0
Testing at 12, 15, 18, 19, 22 and 25 weeks post-activation of cochlear implant

Eligibility
Key inclusion criteria
1. Adult (=18 years of age)

2. Post-operative residual hearing in the implanted ear (defined as having an unaided
threshold better than or equal to 80 dB HL at the 500 Hz frequency).

3. Implanted with the CI500 or CI24RE-series cochlear implants

4. User of the commercially available Nucleus 6 sound processor

5. User of the ACE strategy

6. Native 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
Sex
Both males and females
Can healthy volunteers participate?
No
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
N/A
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/05/2020
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The HEARing CRC - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - 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
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Melbourne
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
When providing amplification post-implantation to residual acoustic hearing in the implanted
ear, the lower frequency boundary can be modified to minimize or avoid overlap between the
frequencies coded through acoustic hearing and those presented through electrical
stimulation. This boundary is termed the cross-over frequency (Fc) and the effect of
modifying this parameter will be investigated in this study. To avoid the research being
confounded by prior bias for a particular frequency allocation, the study will be conducted
with newly implanted recipients.

This study will also investigate whether tests which measure the ability to use low frequency
hearing and objective measures can predict the preferred Fc and speech performance benefit.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02765386
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02765386