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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/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
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Scientific title
Clinical Evaluation of Bass and Treble Controls for CI Subjects
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Secondary ID [1]
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CLTD5640
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Universal Trial Number (UTN)
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Trial acronym
CLASS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hearing Loss
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Condition category
Condition code
Ear
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Deafness
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Non-inferior speech perception with preferred Bass and Treble settings compared to the baseline Bass and Treble settings
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Assessment method [1]
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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.
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Timepoint [1]
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8 weeks
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Secondary outcome [1]
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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
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Assessment method [1]
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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.
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Timepoint [1]
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8 weeks
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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
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Minimum age
6
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2016
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Sample size
Target
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Accrual to date
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Final
34
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Sydney Cochlear Implant Centre - Sydney
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Recruitment hospital [2]
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Cochlear Limited - Sydney
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Recruitment postcode(s) [1]
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2024 - Sydney
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Recruitment postcode(s) [2]
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2109 - Sydney
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Cochlear
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The clinical study is designed to evaluate the safety and effectiveness of recipient
controlled Bass and Treble.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02908737
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Chris D Warren, Audiology
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Address
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Employee
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02908737
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