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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02879539




Registration number
NCT02879539
Ethics application status
Date submitted
21/08/2016
Date registered
25/08/2016

Titles & IDs
Public title
Cochlear Implant Low Power Strategy
Scientific title
Clinical Assessment of a Low Power Strategy for Cochlear Implant Recipients
Secondary ID [1] 0 0
CRC5607
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
Experimental: MP3000-ACE strategy - MP3000 sound coding strategy or ACE strategy with lower stimulation rate
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Word recognition scores in quiet
Timepoint [1] 0 0
Testing over 18 weeks
Primary outcome [2] 0 0
Sentence recognition scores in quiet
Timepoint [2] 0 0
Testing over 18 weeks
Secondary outcome [1] 0 0
Fundamental frequency (F0) discrimination
Timepoint [1] 0 0
Testing over 18 weeks
Secondary outcome [2] 0 0
Speech intelligibility and helpfulness subjective ratings
Timepoint [2] 0 0
Testing over 18 weeks
Secondary outcome [3] 0 0
Sentence in noise scores
Timepoint [3] 0 0
Testing over 18 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 or MP3000 strategy
5. At least 3 months experience with the cochlear implant
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
Randomised controlled 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/01/2017
Sample size
Target
Accrual to date
Final
32
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
Government body
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
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT02879539