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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02908737
Ethics application status
Date submitted
19/08/2016
Date registered
21/09/2016

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
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
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
Sex
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
Not applicable
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
1/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2016
Sample size
Target
Accrual to date
Final
34
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Identifiable data will not be made available to the public. Data will be kept in a secure, locked environment and only the researchers working on the study, relevant authorities and authorised representatives will have access to it.

Subject health records and any information obtained during the research project are subject to inspection (for the purpose of verifying the procedures and the data) by the Food and Drug Administration (FDA) of the United States of America, other national drug regulatory authorities and such as the Australian Government's Therapeutic Goods Administration (TGA), local Ethics Committees, and other duly authorised representatives of the Sponsor, or as required by law.

Study subjects have consented to this.


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/NCT02908737