Hearing LossNCT02746172
Clinical Metrics for Assessing Cochlear Implant Recipient MAPs
A study testing Cochlear implant with in-situ audiometry in people with Hearing Loss, run by The Hearing Cooperative Research Centre at 1 site in Australia.
Trial summary
The aim of this research is to investigate the potential use of specific metrics in assessing the quality and optimising an individual's cochlear implant fitting. Assessment of the sensitivity and specificity of specific metrics that are potential predictors of inaccurate T-levels and C-levels is important to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Cochlear implant with in-situ audiometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteAustralia
- Study dates
- 16 Nov 2015to 17 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (>18 years) cochlear implant recipients
- Implanted with the CI500, CI24RE and Nucleus 24 Series and CI422 cochlear implants.
- User of commercially available Freedom, CP810 or CP900 series sound processor
- User of the ACE strategy
- At least 3 months experience with the cochlear implant
- Fluent speaker in the language used to assess speech perception performance
- Willingness to participate in and to comply with all requirements of the protocol
Who cannot join
- Additional handicaps that would prevent participation in evaluations
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Metrics for Assessing Audibility, Comfort and Performance of Cochlear Implant Recipient MAPs
The aim of this research is to investigate the potential use of specific metrics in assessing the quality and optimising an individual's cochlear implant fitting. Assessment of the sensitivity and specificity of specific metrics that are potential predictors of inaccurate T-levels and C-levels is important to determining best methods for streamlined high quality fitting, providing the potential for feedback to the individual and clinic, as well as automated adjustments for optimisation. Ultimately the objective is to increase clinical capacity for managing both the installed base and new candidates for cochlear implantation.
Read the detailed description
Optimising the clinical fitting of a cochlear implant to an individual listener is an important aspect of post-operative clinical care. The level of success experienced by any individual with a cochlear implant can be influenced, to a significant extent, by the quality of the clinical programming by the audiologist. During clinical programming the audiologist typically measures the amount of electrical charge required to elicit first hearing (the T-level) and to provide a loud but comfortable percept (the C-level) on each of the 22 electrodes. The amount of electrical stimulation required for a threshold and a comfortably loud percept varies across the electrodes of the array and also across individual users. Appropriately set lower and upper electrical stimulation levels are vital for ensuring that the listener is able to detect reasonably soft sounds whilst loud sounds are perceived as loud while remaining comfortable. Achieving this result across the relevant frequency range is a prime aim of programming.
There are a number of challenges in achieving optimal fitting of cochlear implant recipients in the clinical setting. First, there are varying skill levels and experience level of health professionals and allied workers involved in programming devices for cochlear implant recipients, often resulting in variability in the quality of the program (or MAP) provided to an individual. Second, there are varying levels of access to specialized equipment such as sound booths which are required for some types of audiometric measures to be reliably obtained. Finally, there are increasing demands on clinical capacity, with the specialized centres typically treating recipients having limited resources and ability to effectively manage the rapidly increasing population.
As a result, there is an increased need for effective, quality-controlled but streamlined management of implanted recipients.
The aim of the current study is to investigate the potential use of specific metrics in assessing the quality and optimizing an individual's cochlear implant fitting. Assessment of the sensitivity and specificity of specific metrics that are potential predictors of inaccurate T-levels and C-levels is important to determining best methods for streamlined high quality fitting, as well as automated adjustments for optimizing. One of the key objectives is to integrate a new technological advance in the form of in-situ audiometry, which removes the need for a sound booth to conduct audibility checks of the program. Other planned investigations relate to identifying the metrics which best identify maps that are not optimized, and to development and assessment of a range of techniques which may be able to be effectively applied in the clinical setting.
- Conditions
- Hearing Loss
- Being tested
- Cochlear implant with in-situ audiometry
- Keywords
- cochlear implants, Mapping, in-situ audiometry
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear implant with in-situ audiometryDevice
| Study group | Role | What they receive |
|---|---|---|
| Cochlear Implant Recipients | Experimental | cochlear implant recipients Receives: Device: Cochlear implant with in-situ audiometry |
| Normal Hearing Volunteers | No intervention | Normal hearing volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of percentage words/ phonemes correct, in detecting MAPs with inaccurate T and C levels in cochlear implant MAPs.
Measured: Testing over 12 weeks
Sensitivity of speech reception threshold for numbers and sentences in noise, in detecting MAPs with inaccurate T and C levels in cochlear implant MAPs.
Measured: Testing over 12 weeks
Sensitivity of aided hearing thresholds, in detecting MAPs with inaccurate T and C levels in cochlear implant MAPs.
Measured: Testing over 12 weeks
Sensitivity of loudness ratings for narrow band noise presented at different frequencies and levels, in detecting MAPs with inaccurate T and C levels in cochlear implant MAPs.
Measured: Testing over 12 weeks
Secondary outcomes (1)
Test-retest reliability of in-situ aided audiometry
This will be compared to the test-retest reliability of free-field aided audiometry which is within a margin of 10 dB HL.
Measured: Testing over 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study start16 Nov 2015
- Primary completion17 Oct 2017
- Study completion17 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hearing Cooperative Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Victoria Eye and Ear Hospital, Cochlear
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746172
- Sponsor's protocol ID
- CRC5628
- Status last verified
- Jul 2021
- First submitted
- 13 Apr 2016
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Metrics for Assessing Audibility, Comfort and Performance of Cochlear Implant Recipient MAPs
- ClinicalTrials.gov ID
- NCT02746172
- Acronym / sponsor ID
- CRC5628
- Conditions
- Hearing Loss
- Keywords
- cochlear implants, Mapping, in-situ audiometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- The Hearing Cooperative Research CentreUniversity, hospital or other
- Collaborators
- Royal Victoria Eye and Ear Hospital, Cochlear
- Study start
- 16 Nov 2015 (actual)
- Primary completion
- 17 Oct 2017 (actual)
- Study completion
- 17 Oct 2017 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this research is to investigate the potential use of specific metrics in assessing the quality and optimising an individual's cochlear implant fitting. Assessment of the sensitivity and specificity of specific metrics that are potential predictors of inaccurate T-levels and C-levels is important to determining best methods for streamlined high quality fitting, providing the potential for feedback to the individual and clinic, as well as automated adjustments for optimisation. Ultimately the objective is to increase clinical capacity for managing both the installed base and new candidates for cochlear implantation.
Detailed description
Optimising the clinical fitting of a cochlear implant to an individual listener is an important aspect of post-operative clinical care. The level of success experienced by any individual with a cochlear implant can be influenced, to a significant extent, by the quality of the clinical programming by the audiologist. During clinical programming the audiologist typically measures the amount of electrical charge required to elicit first hearing (the T-level) and to provide a loud but comfortable percept (the C-level) on each of the 22 electrodes. The amount of electrical stimulation required for a threshold and a comfortably loud percept varies across the electrodes of the array and also across individual users. Appropriately set lower and upper electrical stimulation levels are vital for ensuring that the listener is able to detect reasonably soft sounds whilst loud sounds are perceived as loud while remaining comfortable. Achieving this result across the relevant frequency range is a prime aim of programming.
There are a number of challenges in achieving optimal fitting of cochlear implant recipients in the clinical setting. First, there are varying skill levels and experience level of health professionals and allied workers involved in programming devices for cochlear implant recipients, often resulting in variability in the quality of the program (or MAP) provided to an individual. Second, there are varying levels of access to specialized equipment such as sound booths which are required for some types of audiometric measures to be reliably obtained. Finally, there are increasing demands on clinical capacity, with the specialized centres typically treating recipients having limited resources and ability to effectively manage the rapidly increasing population.
As a result, there is an increased need for effective, quality-controlled but streamlined management of implanted recipients.
The aim of the current study is to investigate the potential use of specific metrics in assessing the quality and optimizing an individual's cochlear implant fitting. Assessment of the sensitivity and specificity of specific metrics that are potential predictors of inaccurate T-levels and C-levels is important to determining best methods for streamlined high quality fitting, as well as automated adjustments for optimizing. One of the key objectives is to integrate a new technological advance in the form of in-situ audiometry, which removes the need for a sound booth to conduct audibility checks of the program. Other planned investigations relate to identifying the metrics which best identify maps that are not optimized, and to development and assessment of a range of techniques which may be able to be effectively applied in the clinical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cochlear Implant Recipients | Experimental | Device: Cochlear implant with in-situ audiometrycochlear implant recipients |
| Normal Hearing Volunteers | No intervention | –Normal hearing volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult (>18 years) cochlear implant recipients
- Implanted with the CI500, CI24RE and Nucleus 24 Series and CI422 cochlear implants.
- User of commercially available Freedom, CP810 or CP900 series sound processor
- User of the ACE strategy
- At least 3 months experience with the cochlear implant
Key exclusion criteria (2 listed)
- Additional handicaps that would prevent participation in evaluations
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear implant with in-situ audiometry | Device | Cochlear Implant Recipients |
Primary outcome
Sensitivity of percentage words/ phonemes correct, in detecting MAPs with inaccurate T and C levels in cochlear implant MAPs.
Time frame: Testing over 12 weeks
Sensitivity of speech reception threshold for numbers and sentences in noise, in detecting MAPs with inaccurate T and C levels in cochlear implant MAPs.
Time frame: Testing over 12 weeks
Sensitivity of aided hearing thresholds, in detecting MAPs with inaccurate T and C levels in cochlear implant MAPs.
Time frame: Testing over 12 weeks
Sensitivity of loudness ratings for narrow band noise presented at different frequencies and levels, in detecting MAPs with inaccurate T and C levels in cochlear implant MAPs.
Time frame: Testing over 12 weeks
1 secondary outcome
Test-retest reliability of in-situ aided audiometry
Time frame: Testing over 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cochlear implant with in-situ audiometry in people with Hearing Loss, run by The Hearing Cooperative Research Centre at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of percentage words/ phonemes correct, in detecting MAPs with inaccurate T and C levels in cochlear implant MAPs. (time frame: Testing over 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.