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Trial registered on ANZCTR


Registration number
ACTRN12619000992101p
Ethics application status
Submitted, not yet approved
Date submitted
28/05/2019
Date registered
12/07/2019
Date last updated
12/07/2019
Date data sharing statement initially provided
12/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A study comparing speech perception of off-the-ear and behind-the-ear sound processors in adults with hearing loss
Scientific title
A pre-market, prospective, multicentre, open-label, within-subject, interventional study of speech perception with the Kanso off-the-ear sound processor compared with CP910/CP920 behind-the-ear sound processor in adults with hearing loss
Secondary ID [1] 298354 0
CLTD5743
Universal Trial Number (UTN)
U1111-1234-2608
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post lingual deafness 313011 0
Condition category
Condition code
Ear 311517 311517 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of the investigation is to collect data regarding native mandarin language speech perception with the Kanso sound processor compared with the currently available CP10/CP20 sound processor.

Study participants will attend for a single session of one-on-one, face-to-face, sound booth testing using both the Kanso (off-the-ear (OTE) sound processor) and the CP910/CP920 (previous generation behind-the-ear (BTE) sound processor).

Testing will be performed by an audiologist and involve speech perception testing in quite and in noise. The order of testing (i.e. Kanso or CP910/CP920 first) will vary between participants by random assignment, but all participants will be required to complete the tests with both the test device and the comparator device. Individual tests may take about 20 minutes to complete. The total time for all tests is expected to be 2 hours, allowing for up to 20 minutes between treatment arms.

After completing all eligibility and baseline assessments the participants will undergo all tests within a single visit, as described above. An additional visit may be scheduled if the participant is unable to complete all the required tests in one session.
Intervention code [1] 314596 0
Treatment: Devices
Comparator / control treatment
The comparator for this study is the CP910/CP920, which is an off-the-ear sound processor.
The order of testing (i.e. Kanso or CP910/CP920 first) will vary between participants, but all participants will be required to complete the tests with both the comparator device and the test device.
Control group
Active

Outcomes
Primary outcome [1] 320221 0
Sentence in noise scores determined with the Computer-aided Mandarin Speech Test System (HOPE speech perception test)
Timepoint [1] 320221 0
This study consists of a single visit (Visit 1), at which time the primary outcome measure will be assessed
Secondary outcome [1] 370915 0
Recognition of monosyllabic words in quiet scores determined by the percentage correct in 4 lists of 25 monosyllabic words chosen to match the English CNC word test
Timepoint [1] 370915 0
This study consists of a single visit (Visit 1), at which time the secondary outcome measure will be assessed

Eligibility
Key inclusion criteria
1. 18 years or age or older
2. At least 6 months experience with a Nucleus 24 series
3. At least 6 months experience with one of the following sound processors: CP802, CP810, CP910 or CP920
4. Native Mandarin language
5. Signed informed consent
6. Willingness to participate in and to comply with all requirements of the protocol
7. Normal cochlea anatomy bilaterally before implantation
8. Stable MAP for 6 months prior to enrolment
9. Baseline speech in quiet score (>30% syllable maximum speech recognition rate using the HOPE test)

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects who are unable to follow investigational procedures
2. Bipolar, dual electrode or double electrode MAPs
3. Less than 16 hours battery life with current sound processor MAP
4. Concurrent participation is another investigation with pharmaceuticals or medical device
5. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
6. Additional handicaps that would prevent or restrict participation in the audiological evaluations or that would affect the scientific integrity of the study
7. Individuals with lack or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, subjects in emergency situations, homeless persons, and those incapable of giving informed consent
8. Members of a group with a hierarchical structure such as employees of a subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention
9. Patients who wear or have implantable life support devices such as pacemakers and implantable cardioverter defibrillators
10. Pregnant and lactating patients

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
Crossover
Other design features
Within-subject control, with all participants completing testing with both test and comparator devices
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The sample size, (with 97.5% confidence limits) was calculated to detect non-inferiority tests for speech recognition and monosyllabic words in quiet using the Kanso, compared to CP910/CP920.
For non-inferiority tests, the 95% confidence interval (alpha = 0.025 one sided) for the mean paired difference will be estimated and compared with the pre-specified non-inferiority margins. Only when the non-inferiority test is successful, then a superiority test will be conducted to assess the benefit of Kanso or CP910/CP920 sound processor.

Recruitment
Recruitment status
Not yet recruiting
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 outside Australia
Country [1] 21532 0
China
State/province [1] 21532 0
Guangdong and Jiangsu

Funding & Sponsors
Funding source category [1] 302892 0
Commercial sector/Industry
Name [1] 302892 0
Cochlear
Address [1] 302892 0
1 University Ave
Macquarie University
NSW 2109
Country [1] 302892 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cochlear
Address
1 University Ave
Macquarie University
NSW 2109
Country
Australia
Secondary sponsor category [1] 302848 0
Commercial sector/Industry
Name [1] 302848 0
Cochlear Medical Device (Beijing) Co., Ltd
Address [1] 302848 0
Unit 2608, Gemdale Tower B, 91 Jianguo Road
Chaoyang District, Beijing, 100022
Country [1] 302848 0
China

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303466 0
Beijing Friendship Hospital Ethical Committee
Ethics committee address [1] 303466 0
No. 95, Yongan Road
Xicheng District, Beijing City
Beijing 100050
Ethics committee country [1] 303466 0
China
Date submitted for ethics approval [1] 303466 0
02/04/2019
Approval date [1] 303466 0
Ethics approval number [1] 303466 0

Summary
Brief summary
Kanso sound processor is not currently approved for use in mainland China. This study is to test the performance of Kanso using speech testing procedures with native Mandarin speech test materials. Performance will be compared with the currently approved CP910/CP920 sound processor.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93754 0
Prof Shengshu Gong
Address 93754 0
Beijing Friendship Hospital
No. 95 Yongan Road
Xicheng District
Beijng, 100050
Country 93754 0
China
Phone 93754 0
+8610 63139850
Fax 93754 0
Email 93754 0
gongss@ccmu.edu.cn
Contact person for public queries
Name 93755 0
Ms Jin Cong
Address 93755 0
Beijing Friendship Hospital
No. 95 Yongan Road
Xicheng District
Beijng, 100050
Country 93755 0
China
Phone 93755 0
+8610 63139850
Fax 93755 0
Email 93755 0
jincong99@163.com
Contact person for scientific queries
Name 93756 0
Ms Jin Cong
Address 93756 0
Beijing Friendship Hospital
No. 95 Yongan Road
Xicheng District
Beijng, 100050
Country 93756 0
China
Phone 93756 0
+8610 63139850
Fax 93756 0
Email 93756 0
jincong99@163.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results