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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02908737




Registration number
NCT02908737
Ethics application status
Date submitted
19/08/2016
Date registered
21/09/2016
Date last updated
17/01/2018

Titles & IDs
Public title
Clinical Evaluation of Bass and Treble Controls for CI Subjects
Scientific title
Clinical Evaluation of Bass and Treble Controls for CI Subjects
Secondary ID [1] 0 0
CLTD5640
Universal Trial Number (UTN)
Trial acronym
CLASS
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 - Bass and Treble

Experimental: Bass and Treble controls - Bass and Treble controls are clinician enabled and provide the recipient with access to the adjustment of low and high frequency sound balance, known as Bass and Treble respectively.


Treatment: Devices: Bass and Treble
Bass and Treble controls are clinician enabled and provide the recipient with access to the adjustment of low and high frequency sound balance, known as Bass and Treble respectively

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

Outcomes
Primary outcome [1] 0 0
Non-inferior speech perception with preferred Bass and Treble settings compared to the baseline Bass and Treble settings - Co-primary endpoint #1: This endpoint is to test that speech perception scores in noise with preferred Bass and Treble settings are non-inferior to the baseline settings. Subjects will be tested at visit one with their own settings (Baseline), and then again after four weeks use of the Bass and Treble feature. The speech signal will arrive from zero degrees azimuth at a level of 65 dB SPL, the noise will also arrive from zero degrees azimuth, however the noise will adapt according to subject responses.
o-primary endpoint #2: This endpoint is to test that speech perception scores in quiet with preferred Bass and Treble settings are non-inferior to the baseline settings. Subjects will be tested at visit one with their own settings (Baseline), and then again after four weeks use of the Bass and Treble feature. The speech signal will arrive from zero degrees azimuth at a level of 50 dB SPL.
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
Non-inferior sentence recognition in four-talker babble noise with Bass and Treble values set to the minimum (-6 Bass, - 6 Treble) compared to the baseline condition when the speech and noise are from the front - Secondary endpoint #1: This endpoint is to test that speech perception scores in noise with Bass and Treble settings set to minimum (-6, -6) are non-inferior to the baseline settings. Subjects will be tested at visit one. The speech signal will arrive from zero degrees azimuth at a level of 65 dB SPL, the noise will also arrive from zero degrees azimuth, however the noise will adapt according to subject responses.
Timepoint [1] 0 0
8 weeks

Eligibility
Key inclusion criteria
1. Six years of age or older

2. At least 3 months experience with the CP810, CP910 or CP920 sound processor

3. At least 3 months experience with the CI24RE or CI500 series implant

4. Willingness to participate in and to comply with all requirements of the protocol
Minimum age
6 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Unrealistic expectations on the part of the subject, regarding the possible benefits,
risks and limitations that are inherent to the procedure and prosthetic device

2. Additional disabilities that would prevent participation in evaluations

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Cochlear Implant Centre - Sydney
Recruitment hospital [2] 0 0
Cochlear Limited - Sydney
Recruitment postcode(s) [1] 0 0
2024 - Sydney
Recruitment postcode(s) [2] 0 0
2109 - Sydney

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

Ethics approval
Ethics application status

Summary
Brief summary
The clinical study is designed to evaluate the safety and effectiveness of recipient
controlled Bass and Treble.
Trial website
https://clinicaltrials.gov/show/NCT02908737
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chris D Warren, Audiology
Address 0 0
Employee
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
Other publications