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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/NCT03126825




Registration number
NCT03126825
Ethics application status
Date submitted
20/04/2017
Date registered
24/04/2017
Date last updated
17/01/2018

Titles & IDs
Public title
CLEAR Clinical Study
Scientific title
Clinical Evaluation of the SpatialNR Noise Reduction Algorithm
Secondary ID [1] 0 0
CLTD5606
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 - CP910/CP920 with noise reduction on
Treatment: Devices - CP910/CP920

Other: Conventional CI - The conventional CI group will receive the noise reduction on and off signal processing test programs. This is a within subject repeated measures design, so all subjects will receive the same testing but in a counterbalanced order.

Other: Hybrid CI - The Hybrid CI group will receive the noise reduction on and off signal processing test programs. This is a within subject repeated measures design, so all subjects will receive the same testing but in a counterbalanced order.


Treatment: Devices: CP910/CP920 with noise reduction on
This intervention uses the approved Nucleus 6 system (CP910/CP920 and accessories) but adds the investigational noise reduction algorithm.

Treatment: Devices: CP910/CP920
The approved CP910 or CP920 Sound Processor.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
CNC words
Timepoint [1] 0 0
3 months
Primary outcome [2] 0 0
SRT sentences
Timepoint [2] 0 0
3 months

Eligibility
Key inclusion criteria
1. Conventional CI subject aged twelve years of age or older, or Hybrid subject aged 18
years or older

2. Recipient of a CI500 Series (CI512 or CI522) or CI24RE Series (CI24REH or CI422)
cochlear implant

3. At least three months CI experience in ear to be assessed

4. At least three months experience with the CP810,CP920 or CP910 sound processor

5. Fluent speaker in the local language used to assess clinical performance

6. Open-set speech perception ability

7. Use of or eligibility for hybrid acoustic component (hybrid population only)
Minimum age
6 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 the investigational device

2. Unwillingness or inability of the candidate to comply with all investigational
requirements

3. Additional handicaps that would prevent or restrict participation in the audiological
evaluations or that would affect the scientific integrity of the study.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2017
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Cochlear Limited Sydney - Sydney
Recruitment hospital [2] 0 0
Cochlear Limited Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
2109 - Sydney
Recruitment postcode(s) [2] 0 0
3002 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cochlear
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Acute in-booth assessment of a new noise reduction algorithm with cochlear implant
recipients.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03126825
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mary Beth Brinson, Phd
Address 0 0
Head of Global Clinical Affairs
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/NCT03126825