Trial Review

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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/NCT02984748




Registration number
NCT02984748
Ethics application status
Date submitted
4/12/2016
Date registered
7/12/2016
Date last updated
6/07/2021

Titles & IDs
Public title
Outcome Prediction in Cochlear Implant Recipients
Scientific title
Prediction of Outcomes in Adult Cochlear Implant Recipients
Secondary ID [1] 0 0
CLTD 5565
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
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Cochlear implant

Cochlear Implant Recipients -


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

Outcomes
Primary outcome [1] 0 0
Speech recognition in quiet
Timepoint [1] 0 0
Testing over 12 months
Primary outcome [2] 0 0
Speech recognition in noise
Timepoint [2] 0 0
Testing over 12 months

Eligibility
Key inclusion criteria
1. Clinical suitability for first side implantation, i.e. not undergoing assessment for
second side cochlear implant surgery

2. Willing and able to attend the study visits

3. Able to provide informed consent for participation in the study, with an understanding
of the requirements, risks and benefits of participation in the investigation

4. Able to read and understand study documents and follow investigator instructions

5. Able to understand and follow study personnel instructions during audiological
measurements

6. Native speaker in the language used to assess clinical speech perception performance
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unrealistic expectations on the part of the subject regarding the possible benefits,
risks, and limitations that are inherent to enrolment in the clinical investigation.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2020
Sample size
Target
Accrual to date
Final
267
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
Commercial sector/Industry
Name [1] 0 0
Cochlear
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Attune Hearing
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Sydney Cochlear Implant Clinic
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The ability to predict post-operative outcomes after implantation is important for a number
of reasons, including being able to advise candidates of appropriate expectations using
evidence based guidance. The approved study involves investigation of the ability to predict
outcomes in the implanted ear alone and in the best-aided binaural listening conditions,
examining a number of measured factors both pre-, peri- and post-operatively. The study
incorporates a range of functional outcome measures through questionnaires to ascertain
social, functional and demographic factors that may be predictive of outcomes. Questionnaires
are also administered to determine the degree of benefit obtained after implantation for each
individual, since this forms a key component of providing pre-operative counselling to
candidates.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02984748
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/NCT02984748