ANZCTR - Registration

Registration number

ACTRN12620001300965

Ethics application status

Approved

Date submitted

23/04/2020

Date registered

1/12/2020

Date last updated

19/05/2022

Date data sharing statement initially provided

1/12/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

Performance barriers for cochlear implant recipients

Scientific title

A prospective, multi-centre case-control trial examining factors that predict variable clinical performance in post lingual adult CI recipients

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

PREVA

Linked study record

Health condition

Health condition(s) or problem(s) studied:

auditory sensitivity

cochlear implant

Condition category

Condition code

Ear

Deafness

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The purpose is to examine factors that predict variable clinical performance in post-lingual adult cochlear implant recipients. The approved medical device on test (AMDTs) include models CI24RE (CA), CI422, CI512, CI522, CI612, CI622, CI532, CI632. These AMDTs provide auditory sensation and sound perception by electrically stimulating the auditory nerve of a hearing-impaired ear for individuals aged 18 years and older who have clinically established postlinguistic bilateral or unilateral sensorineural hearing loss and who have compromised functional hearing with hearing aids or would receive no benefit with hearing aids. Typical preoperative threshold levels in the impaired ears demonstrate a pure-tone average of moderately severe to profound degree.
After screening, participants will attend three face-to-face, on-site visits with an optional fourth visit where tests will be administered by the qualified audiologist Site Investigators. Visit 1 will occur on the screening day where standard clinical tests, MAPping procedures, words in quiet and loud, sentences in noise, aided thresholds and digit triplet test will be done. Visit 2 will occur within 60 days of screening where standard tests IOI questionnaire and non-standard tests BP T-level (Psychophysical), BP C-levels, Language Independent Test (LIT), Quick Spectral Modulation Detection (QSMD), Amplitude Modulation Detection Threshold (AMDT), IPG Change, Polarity Effect (PE) NRT 4 point impedance and Voltage matrix/Trans Impedance matrix (TIM) will be done, and Visit 3 will be subsequent to Visit 2 but within 90 days of screening where standard tests MoCA and Vocab test and non-standard tests SMDT, PDQ at 65 dB SPL and 50 dB SPL, Polarity Effect (Psychophysical), Spread of Excitation (SOE), Refractory/Recovery and Stroop will be done. The optional 4th visit is for subjects who for some reason are unable to complete testing in three visits and for subjects who are tested on the outcome measures with a changed MAP. There will be an initial pilot phase with one three-hour session including screening to confirm that the diagnostic test measures are operating as intended and to confirm the time required to administer the tests. The first five subjects recruited from either site will participate in this pilot phase and will be included in the main study. The Pilot Visit non-standard tests are biopolar T-levels, Bipolar C- levels, Polarity Tests (Behavioural), AMDT, QSMD and time permitting 4 point impedance and SOE (ECAP). For the main phase, the screening/initial visit will occur on the same day followed by two follow-up visits. All visits are anticipated to be approximately three to four hours in duration. These sessions will include appropriate breaks for the recipient to prevent fatigue. Non-standard tests utilise software tools that are part of the standard battery to test measures that are not standard clinical test battery.
The fidelity to the tests will be assessed and monitored through Source Data Validation five times at each site throughout the study in accordance with Visit 1 will occur following the completion of the first 5 subjects, Visit 2 will occur following the completion of the first 25 subjects, Visit 3 will occur following the completion of the first 50 subjects, Visit 4 will occur following the completion of the first 75 subjects and the final close out monitoring visit will take place after the last subject has completed data collection.
There will 200 subjects enrolled in the study, with 100 enrolled at each of the two sites (60 poorer performers and 40 good performers). Subjects who withdraw from the study will be replaced. The enrolment period for the clinical investigation is anticipated to be 22 months from the time of first subject consent to enrolment of the last subject. The expected duration of each subject’s participation in the clinical investigation is up to two months from the time of informed consent through to the End of Study visit.
The design is mainly prospective. However, it incorporates collection of retrospective speech perception and imaging data. The latter will enable analysis of the potential influence of anatomical and surgical placement variability on CI outcomes.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Post-implantation outcome measures of auditory sensitivity, aided thresholds at 250, 500, 750, 1000, 1500, 2000, 3000, 4000 and 6000Hz in Visit 1.

Timepoint [1]

Up to two months from the time of informed consent through to the End of Study visit. Timepoints relative to participants are screening/baseline, 60 days, 90 days 120 days (if optional 4th visit completed).

Primary outcome [2]

Post-implantation outcome measures of auditory sensitivity, phoneme discrimination in noise (LIT) and in quiet (PDQ) in Visit 2.

Timepoint [2]

Up to two months from the time of informed consent through to the End of Study visit. Timepoints relative to participants are screening/baseline, 60 days, 90 days 120 days (if optional 4th visit completed).

Primary outcome [3]

Post-implantation outcome measures of auditory sensitivity, Quick Spectral Modulation Detection (QSMD) test in Visit 2.

Timepoint [3]

Up to two months from the time of informed consent through to the End of Study visit. Timepoints relative to participants are screening/baseline, 60 days, 90 days 120 days (if optional 4th visit completed).

Secondary outcome [1]

Post-implantation outcome measures of auditory sensitivity, Amplitude Modulation Detection Threshold (AMDT Test) in Visit 2.

Timepoint [1]

Up to two months from the time of informed consent through to the End of Study visit. Timepoints relative to participants are screening/baseline, 60 days, 90 days 120 days (if optional 4th visit completed).

Secondary outcome [2]

Binary performance on a monosyllabic word in quiet test at a conversational level of 65 dB in the implanted ear in screening.

Timepoint [2]

Up to two months from the time of informed consent through to the End of Study visit. Timepoints relative to participants are screening/baseline, 60 days, 90 days and 120 days (if optional 4th visit completed).

Secondary outcome [3]

Difference in CI alone sentence in noise scores (Visit 1 minus pre-operative).

Timepoint [3]

Up to two months from the time of informed consent through to the End of Study visit. Timepoints relative to participants are screening/baseline, 60 days, 90 days 120 days (if optional 4th visit completed).

Secondary outcome [4]

Aided thresholds are the outcome measures. Aided thresholds will be measured for the implanted ear at 250, 500, 1000, 2000, 3000, 4000, 6000 Hz (Visit 1)

Timepoint [4]

Up to two months from the time of informed consent through to the End of Study visit. Timepoints relative to participants are screening/baseline, 60 days, 90 days 120 days (if optional 4th visit completed).

Secondary outcome [5]

Auditory sensitivity outcomes in phoneme discrimination (LIT in visit 2) and (PDQ in Visit 3)).

Timepoint [5]

Up to two months from the time of informed consent through to the End of Study visit. Timepoints relative to participants are screening/baseline, 60 days, 90 days 120 days (if optional 4th visit completed).

Secondary outcome [6]

Auditory sensitivity outcomes in spectral resolution measured with the QSMD in Visit 2 and temporal resolution with the AMDT in Visit 2.

Timepoint [6]

Up to two months from the time of informed consent through to the End of Study visit. Timepoints relative to participants are screening/baseline, 60 days, 90 days 120 days (if optional 4th visit completed).

Secondary outcome [7]

Auditory sensitivity outcomes in temporal resolution with the AMDT in Visit 2.

Timepoint [7]

Up to two months from the time of informed consent through to the End of Study visit. Timepoints relative to participants are screening/baseline, 60 days, 90 days 120 days (if optional 4th visit completed).

Secondary outcome [8]

Percent correct words in quiet in Visit 1 at 65 dB SPL in the CI alone condition.

Timepoint [8]

Up to two months from the time of informed consent through to the End of Study visit. Timepoints relative to participants are screening/baseline, 60 days, 90 days 120 days (if optional 4th visit completed).

Secondary outcome [9]

Sentence in noise scores in Visit 1 in the CI alone and best bilateral conditions

Timepoint [9]

Up to two months from the time of informed consent through to the End of Study visit. Timepoints relative to participants are screening/baseline, 60 days, 90 days 120 days (if optional 4th visit completed).

Secondary outcome [10]

Percent correct words in quiet in Visit 1 at 65 dB SPL in the CI alone condition for the Melbourne site versus the German site

Timepoint [10]

Up to two months from the time of informed consent through to the End of Study visit. Timepoints relative to participants are screening/baseline, 60 days, 90 days 120 days (if optional 4th visit completed).

Secondary outcome [11]

Pre-operative PB max score on Freiburg words in quiet under headphones (MHH site only) minus the percent words in quiet at 65 dB SPL in the CI alone condition in Visit 1.

Timepoint [11]

Up to two months from the time of informed consent through to the End of Study visit. Timepoints relative to participants are screening/baseline, 60 days, 90 days 120 days (if optional 4th visit completed).

Eligibility

Key inclusion criteria

1. Minimum duration of cochlear implant experience of 12 months in the ear to be assessed
2. Implanted greater than or equal to 2007 in the ear to be assessed in the study.
3. Word recognition score in quiet at a conversational level that is either a) below the 35th percentile (“poorer”) or b) above the 65th percentile of the site’s implanted population (implanted greater than or equal to 2007) at the site AND greater than or equal to 10% higher than the pre-operative aided word score in the ear to be assessed in the study (“good”).
4. Pre-operative word score in the implanted ear to be assessed in the study less than or equal to 80%
5. 18 years of age or older at the time of implantation of the ear to be assessed in the study.
6. Appropriate pre- and post-operative imaging; specifically, pre-operative MRI, pre-operative CT and post-operative CT that allows sufficient resolution to identify individual electrode contacts.
7. Willingness to participate in and to comply with all requirements of the protocol.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

1) Limited conditioning of the auditory pathway. Specifically, recipients to be excluded are those who were diagnosed with prelingual severe to profound hearing loss at less than or equal to 2 years of age AND meet at least one of the following criteria
i. Use non-speech based means as a primary mode of communication (for example, sign language)
ii. Have an aided post operative word score in quiet at 65 dB SPL in the implanted ear that is less than 5%
2) Diagnosed cognitive deficit deemed by the investigators to potentially impact outcomes
3) Restricted electrical frequency allocation table due to current use of combined electric-acoustic stimulation (either with or without amplification in the ear to be assessed)
4) Non-fluent in the language used for assessments at the investigational site
5) Additional handicaps that would prevent participation in evaluations
6) Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigation
7) Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
8) Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
9) Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

Study design

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

22/10/2020

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

1/08/2022

Actual

Sample size

Target

200

Accrual to date

88

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment outside Australia

Country [1]

Germany

State/province [1]

Lower Saxony

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Cochlear Limited

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Cochlear Limited

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Victorian Eye and Ear Hospital (RVEEH)

Ethics committee address [1]

Eye and Ear on the Park, St Andrews Place, 
East Melbourne, Vic, 3002

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

26/03/2020

Ethics approval number [1]

20/1457H

Summary

Brief summary

The purpose of this research project is to identify which factors are important in explaining the benefit obtained after implantation. The ability to understand words and sentences in noise varies across people who have been implanted with the cochlear implant. This study is particularly interested in understanding differences in the way in which cochlear implant recipients can discriminate the important cues of pitch and timing in speech sounds. The discrimination of these cues is essential for speech understanding. The study will investigate the influence of a range of factors on the ability to discriminate these cues; factors such as the anatomy of the cochlea, the health of the nerve fibres in the cochlea and the sound processor MAP settings.

Trial website

Public notes

Contacts

Principal investigator

Name

Prof Robert Cowan

Address

HEARnet Ltd
550 Swanston Street
Carlton VIC 3053

Country

Australia

Phone

+61 03 90354710

Email

[email protected]

Contact person for public queries

Name

Herah Hansji

Address

Cochlear Limited
1 University Avenue
Macquarie University
NSW 2109

Country

Australia

Phone

+61 03 86623107

Email

[email protected]

Contact person for scientific queries

Name

Pam Dawson

Address

Cochlear Limited
1 University Avenue
Macquarie University
NSW 2109

Country

Australia

Phone

+61 0386623107

Email

[email protected]

Trial Review

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Documents added automatically